As substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level.
treatment at doses of 10mg/2.5mg/5mg and 10mg/2.5mg/10mg is contraindicated. In patients with creatinine clearance greater than or equal to 60ml/min, no dose modification is required. Hepatic impairment: Contraindicated in patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, Perindopril/ Indapamide/Amlodipine should be administrated with caution, as dosage recommendations for amlodipine in these patients have not been established. Contraindications: Hypersensitivity to the active substances, to other sulphonamides, to dihydropyridine derivatives, any other ACE-inhibitor or to any of the excipients. History of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy. Dialysis patients. Patients with untreated decompensated heart failure. Severe renal impairment. Moderate renal impairment for Perindopril/ Indapamide/Amlodipine 10mg/2.5mg/5mg and 10mg/2.5mg/10mg. Hereditary/ idiopathic angioedema. Second and third trimesters of pregnancy. Hepatic encephalopathy. Severe hepatic impairment. Hypokalaemia. Combination with nonantiarrhythmic agents causing Torsades de Pointes. Severe hypotension. Shock, including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (e.g. high-grade aortic stenosis). Haemodynamically unstable heart failure after acute myocardial infarction. Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment. Concomitant use with sacubitril/valsartan therapy. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Precautions and warnings: The combination of lithium and the combination of perindopril/indapamide is usually not recommended. There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). If dual blockade therapy is considered necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. The combination of perindopril and potassium-sparing drugs, potassium supplements or potassium containing salt substitutes is usually not recommended. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. There is an increased risk of hypotension and renal insufficiency when patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors. Treatment with diuretics may be a contributory factor. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, including
Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67E5AO, Ireland. Freephone: 1800 - 201 700 | Email: info@teva.ie
perindopril. This may occur at any time during treatment. In such cases perindopril should be discontinued promptly. Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution and/or measures to ensure a patent airway, should be administered promptly. There have been isolated reports of patients experiencing sustained, life-threatening anaphylactoid reactions while receiving ACE inhibitors during desensitisation treatment with hymenoptera (bees, wasps) venom. ACE inhibitors should be used with caution in allergic patients treated with desensitisation and avoided in those undergoing venom immunotherapy. Rarely, patients receiving ACE inhibitors during low density lipoprotein (LDL)-apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE-inhibitor therapy prior to each apheresis. Patients with primary hyperaldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the reninangiotensin system. Therefore, the use of this product is not recommended. ACE inhibitors should not be initiated during pregnancy; when pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately. When liver function is impaired, administration of the diuretic should be stopped immediately if this occurs. If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun. Thiazide diuretics and thiaziderelated diuretics may reduce urinary excretion of calcium and cause a mild and transient increase in plasma calcium levels. Thiazides and related diuretics including indapamide have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia. If Perindopril/Indapamide/Amlodipine is prescribed to patients with known or suspected renal artery stenosis, treatment should be started in a hospital setting at a low dose and renal function and potassium levels should be monitored, since some patients have developed a functional renal insufficiency which was reversed when treatment was stopped. A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. If the prescription of an angiotensin converting enzyme inhibitor is still preferred, continuation of treatment may be considered. The risk of hypotension exists in all patients, but particular care should be taken in patients with ischaemic heart disease or cerebral circulatory insufficiency, with treatment being started at a low dose. The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with heart failure should be treated with caution. ACE inhibitors should be used with caution in patients with an obstruction in the outflow tract of the left ventricle. In patients with insulin dependent diabetes mellitus (spontaneous tendency to increased levels of potassium), treatment should be started under medical supervision with a reduced initial dose. As with other angiotensin converting enzyme inhibitors, perindopril is apparently less effective in lowering blood pressure in black patients than in non-black patients, possibly because of a higher prevalence of low-renin states in the black hypertensive population. Angiotensin converting enzyme inhibitors can cause hypotension in cases of anaesthesia, it is therefore recommended that treatment with long-acting angiotensin converting enzyme inhibitors such as perindopril should be discontinued where possible one day before surgery. Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Tendency to gout attacks may be increased in hyperuricaemic patients.
Interactions: Concomitant use of ACE inhibitors with sacubitril/valsartan, racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and gliptins
(e.g. linagliptin, saxagliptin, sitagliptin, vildagliptin) may lead to an increased risk for angioedema. Hyperkalaemia may occur in some patients treated with Perindopril/ Indapamide/Amlodipine. Some drugs or therapeutic classes may increase the occurrence of hyperkalaemia: aliskiren, potassium salts, potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride), ACE inhibitors, angiotensin-II receptors antagonists, NSAIDs, heparins, immunosuppressant agents such as ciclosporine or tacrolimus, trimethoprim and cotrimoxazole (trimethoprim/ sulfamethoxazole), as trimethoprim is known to act as a potassium-sparing diuretic like amiloride. The combination of these drugs increases the risk of hyperkalaemia, therefore, the combination of Perindopril/Indapamide/Amlodipine with the abovementioned drugs is not recommended. If concomitant use is indicated, they should be used with caution and with frequent monitoring of serum potassium. Please refer to the SmPC for the full list of known interactions with concomitant products which are either contraindicated, “not recommended”, or “require special care”. Pregnancy and lactation: Not recommended during the first trimester of pregnancy. This medicine is contraindicated during the second and third trimesters of pregnancy. Perindopril/Indapamide/Amlodipine is contraindicated during lactation. A decision should be made whether to discontinue nursing or to discontinue Perindopril/ Indapamide/Amlodipine taking account the importance of this therapy for the patient. Effects on ability to drive and use machines: No studies on the effects of fixed combination of perindopril/indapamide/amlodipine on the ability to drive and use machines have been performed. Perindopril and indapamide have no influence on the ability to drive and use machines but individual reactions related to low blood pressure may occur in some patients. Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients suffer from dizziness, headache, fatigue, weariness or nausea, the ability to react may be impaired. Adverse reactions: Agranulocytosis, aplastic anaemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia, hypersensitivity, hyperkalaemia, hypokalaemia, syncope, peripheral neuropathy, angina pectoris, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, Torsade de Pointes (potentially fatal), pancreatitis, gastritis, hepatitis, jaundice, pemphigoid, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, rhabdomyolysis, renal failure, electrocardiogram QT prolongation. Common: Dizziness, headache, paraesthesia, dysgeusia, visual impairment, tinnitus, vertigo, hypotension, cough, dyspnoea, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, pruritus, rash, muscle spasms, asthenia. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: There is no information on over-dosage with fixed combination of perindopril/indapamide/amlodipine in humans. For perindopril/indapamide combination the most likely adverse reaction in cases of overdose is hypotension, sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion. For amlodipine, experience with intentional overdose in humans is limited. Gross overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported. Non-cardiogenic pulmonary oedema has rarely been reported that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Please refer to the SmPC for full guidance on management of overdosage. Legal category: POM. Marketing Authorisation Number: PA1986/108/001-004. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands. Job Code: MED-IE-00091. Date of Preparation: January 2025
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com
Prescription Only Medicine. Further information is available on request or in the SmPC. Product Information also available on the HPRA website. Date of Preparation: January 2025 | Job Code: GEN-IE-00114
Introducing Venlatev (venlafaxine)
Venlatev replaces Ireven
Indications
Venlatev 37.5 mg, 75 mg and 150 mg hard prolonged-release capsules
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of generalised anxiety disorder.
Venlatev (venlafaxine hydrochloride) Hard Prolonged-Release Capsules Abbreviated Prescribing Information. Presentation: Each hard prolongedrelease capsule contains venlafaxine hydrochloride, equivalent to 37.5mg, 75mg and 150mg of venlafaxine respectively. Indications: Treatment of major depressive episodes, generalised anxiety disorder, social anxiety disorder, and panic disorder, with or without agoraphobia. Also indicated for the prevention of recurrence of major depressive episodes. Dosage and administration: For oral use. Adults: For the treatment of major depressive episodes, the recommended dose is 75m/day, up to a maximum of 375mg/day for patients not responding to the initial dose (dose increases can be made at no less than 4-day intervals). For generalised anxiety disorder and social anxiety disorder, the recommended dose is 75mg/day, up to a maximum of 225mg/day (dose increases can be made at intervals of 2 weeks or more). For panic disorder, the recommended dose is 37.5mg/day for 7 days, then increased to 75mg/day, up to a maximum of 225mg/ day (dose increases can be made at intervals of 2 weeks or more). Treatment across all indications should be assessed on a case-by-case basis. Consult the SmPC for full details. Children and Adolescents: Not recommended for use in children and adolescents under the age of 18 years. Elderly: No specific dose adjustments of venlafaxine are considered necessary based on patient age alone, however, caution should be exercised in treating the elderly. The lowest effective dose should always be used. Renal impairment: No change in dose is necessary for patients with glomerular filtration rate (GFR) between 30-70 ml/minute, however, caution is advised. For patients that require haemodialysis and in patients with severe renal impairment (GFR < 30 ml/min), the dose should be reduced by 50%. Because of inter-individual variability in clearance in these patients, individualisation of dosage may be desirable. Hepatic impairment: In patients with mild and moderate hepatic impairment, in general a 50% dose reduction should be considered. However, due to inter-individual variability in clearance, individualisation of dose may be desirable. There are limited data in patients with severe hepatic impairment. Caution is advised, and a dose reduction by more than 50% should be considered. The potential benefit should be weighed against the risk in the treatment of patients with severe hepatic impairment. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome. Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI. Precautions and warnings: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment. As with other serotonergic agents, serotonin syndrome, a potenially life-threatening condition, may occur with venlafaxine treatment, particularly with concomitant use of other substances that affect the serotonergic neurotransmitter system. If concomitant treatment with venlafaxine and other medicinal products that may affect the serotonergic and/or dopaminergic neurotransmitter systems is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and
dose increases. Mydriasis may occur in association with venlafaxine. It is recommended that patients with raised intraocular pressure or patients at risk for acute narrow-angle glaucoma (angle-closure glaucoma) be closely monitored. Dose-related increases in blood pressure have been commonly reported with venlafaxine. In some cases, severely elevated blood pressure requiring immediate treatment has been reported in post-marketing experience. All patients should be carefully screened for high blood pressure and pre-existing hypertension should be controlled before initiation of treatment. Increases in heart rate can occur, particularly with higher doses. Caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate. Venlafaxine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease, therefore, it should be used with caution in these patients. Convulsions may occur with venlafaxine therapy. Venlafaxine should be introduced with caution in patients with a history of convulsions, and concerned patients should be closely monitored. Treatment should be discontinued in any patient who develops seizures. Cases of hyponatraemia and/or the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion may occur with venlafaxine. Venlafaxine should be used cautiously in patients predisposed to bleeding, including patients on anticoagulants and platelet inhibitors. Clinically relevant increases in serum cholesterol were recorded in venlafaxine-treated patients, therefore, measurement of serum cholesterol levels should be considered during long-term treatment. Mania/hypomania may occur in a small proportion of patients with mood disorders who have received antidepressants, including venlafaxine. Venlafaxine should be used cautiously in patients with a history or family history of bipolar disorder. Aggression may occur in a small number of patients who have received antidepressants, including venlafaxine. The use of venlafaxine has been associated with the development of akathisia. In patients with diabetes, treatment with an SSRI or venlafaxine may alter glycaemic control. Insulin and/or oral antidiabetic dose may need to be adjusted. Serotonin-norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SNRIs. Venlafaxine should be gradually tapered when discontinuing treatment over a period of several weeks or months according to the patient’s needs. Interactions: Venlafaxine must not be used in combination with irreversible non-selective MAOIs. Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI. Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible non-selective MAOI. Due to the risk of serotonin syndrome, the combination of venlafaxine with a reversible and selective MAOI, is not recommended. may occur with venlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic neurotransmitter system. If concomitant treatment with venlafaxine and an SSRI, an SNRI or a serotonin receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of venlafaxine with serotonin precursors is not recommended. Caution is advised if a patient’s therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly, as this may lead to an increase in levels of venlafaxine and O-desmethylvenlafaxine Serotonin syndrome may occur with the concomitant use of venlafaxine and lithium. Caution should be exercised with co-administration of venlafaxine and imipramine and metoprolol. Pregnancy and lactation: Venlafaxine must only be
Treatment of social anxiety disorder.
Treatment of panic disorder, with or without agoraphobia.
administered to pregnant patients if the expected benefits outweigh any possible risk. Discontinuation symptoms may occur in the newborns if venlafaxine is used until or shortly before birth. Some newborns exposed to venlafaxine late in the third trimester have developed complications requiring tube-feeding, respiratory support or prolonged hospitalisation. Such complications can arise immediately upon delivery. Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth. A risk to the suckling child cannot be excluded, therefore, a decision to continue/ discontinue breast-feeding or to continue/discontinue therapy with Venlatev should be made, taking into account the benefit of breast-feeding to the child and the benefit of Venlatev therapy to the woman. Effects on ability to drive and use machines: Venlatev may impair judgment, thinking, and motor skills. Therefore, any patient receiving venlafaxine should be cautioned about their ability to drive or operate hazardous machinery. Adverse reactions: Agranulocytosis, aplastic anaemia, pancytopaenia, neutropaenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, thrombocytopenia, delirium, neuroleptic malignant syndrome (NMS), serotonin syndrome, convulsion, tardive dyskinaesia, suicidal ideation, suicidal behaviours, Torsade de pointes, ventricular tachycardia, ventricular fibrillation, angle-closure glaucoma, pancreatitis, hepatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, rhabdomyolysis. Very Common: Insomnia, headache, dizziness, sedation, nausea, dry mouth, constipation, hyperhidrosis (including night sweats). Common: Decreased appetite, confusional state, depersonalisation, abnormal dreams, nervousness, libido decreased, agitation, anorgasmia, akathisia, tremor, paraesthesia, dysgeusia, visual impairment, accommodation disorder, including blurred vision, mydriasis, tinnitus, tachycardia, palpitations, hypertension, hot flush, dyspnoea, yawning, diarrhoea, vomiting, rash, pruritus, hypertonia, urinary hesitation, urinary retention, pollakiuria, menorrhagia, metrorrhagia, erectile dysfunction, ejaculation disorder, fatigue, asthenia, chills, weight decreased/increased, blood cholesterol increased. Consult the SmPC in relation to other side effects. Overdose: In post-marketing experience, overdose with venlafaxine was reported predominantly in combination with alcohol and/or other medicinal products, including cases with fatal outcome. Severe poisoning symptoms may occur in adults after intake of approximately 3g of venlafaxine. Published retrospective studies report that venlafaxine overdose may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressants, but lower than that for tricyclic antidepressants. Severe poisoning may require complex emergency treatment and monitoring. Therefore, in event of suspected overdose involving venlafaxine, prompt contact with national poison information centre is recommended. General supportive and symptomatic measures are recommended; cardiac rhythm and vital signs must be monitored. When there is a risk of aspiration, induction of emesis is not recommended. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Administration of activated charcoal may also limit absorption of the active substance. Legal category: POM. Marketing Authorisation Number: PA1986/099/001-003. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands. Job Code: MED-IE-00085. Date of Preparation: September 2024.
Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67E5AO, Ireland.
Freephone: 1800 - 201 700 | Email: info@teva.ie
Prescription Only Medicine.
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie.
Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com
Date of Preparation: January 2025 | Job Code: 00100
Further information is available on request or in the SmPC. Product Information also available on the HPRA website.
Code: 67244
Contents Foreword
Flexible Training for Doctors ‘Consistently Low’ P5
Major Step Forward in Lung Cancer Detection P6
Professor Wang wins 2025 NovaUCD Innovation Award P8
Cost Implication of UWWTD on Medicines P12
Mater Private Network Annual Heart Summit P14
Review of the Irish Melanoma Forum 2024 P19 REGULARS
Editor
We lead the news with details on page 6 of a major step forward in the early detection of lung cancer, which has been taken with the launch of the Beaumont RCSI Irish Cancer Society Lung Health Check, a first-of-its-kind pilot clinical trial in Ireland. Funded by the Irish Cancer Society, this initiative will bring life saving lung health checks directly into the communities of North Dublin and the North East through mobile scanning units.
Feature: Understanding Diabetes - Type 1 vs Type 2 P22
Hospital Professional News is a publication for Hospital Professionals and Professional educational bodies only. All rights reserved by Hospital Professional News. All material published in Hospital Professional News is copyright and no part of this magazine may be reproduced, stored in a retrieval system or transmitted in any form without written permission.
IPN Communications Ltd have taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.
In one of our other key news stories this issue, Dr Lucy Jessop, Director of the National Immunisation Office gives readers an overview of the National Immunisation Office Strategic Plan for 2024-2027.
Ensuring equitable access to immunisation and strengthening vaccine programmes are critical to protecting public health in Ireland. The National Immunisation Office (NIO) Strategic Plan 2024-2027 sets out a targeted approach to enhancing immunisation services, addressing emerging challenges, and supporting healthcare professionals in delivering high quality, evidence based vaccination programmes.
You can read more about this on page 10.
In other news, Medicines for Ireland Medicines for Ireland (MFI) has warned about the devastating impact of the cost of implementation of the Urban Wastewater Treatment Directive (UWWTD) on the supply of the majority of medicines for Irish patients.
SALES EXECUTIVE
Jean Lonergan
jean@hospitalprofessionalnews.ie +353 87 288 2371
SALES & TRAINING MANAGER
Amy Evans | amy@ipn.ie 0872799317
CONTRIBUTORS
Dr Lyle McVicker | Lisa Wynne
Dr Deirdre Philbin | Dr Shameer Rafee
Zoe McCrudden | Sharon Maher
Ciara Cahill | Dan Atar | Irene Gibson
Mr. Sadiq Siddiqui | Mr Ronan Kelly
Dr Johann Leunbach | Dr Ella Patchett
Professor Alan Soo | Dr Karl Hazel
Dr. Fiona McGillicuddy
Professor Helen Roche
Professor Lis Neubeck
Professor Niall Tubridy
Professor Dominic Hegarty
Professor Desmond J. Tobin
Professor Shirley Potter
Professor Peter O’Gorman
Professor Derek O’Keeffe
DESIGN DIRECTOR
Ian Stoddart Design
The warning comes after several generic medicines suppliers, supported by Medicines for Europe, filed a legal case with the Court of Justice of the European Union against the creation of an Extended Producer Responsibility (EPR) scheme under the Urban Wastewater Treatment Directive (UWWTD). The legal action seeks to avoid a discriminatory and disproportionate cost burden on generic medicines, therefore safeguarding patient access to vital medicines.
The Special Focus for April is on Cardiology with a host of excellent clinically contributed articles including Dr Fiona McGillicuddy and Professor Helen Roche discussing Biomarkers to Support Personalised Health and Precision Nutrition in Cardiometabolic Disease on page 33; Zoe McCrudden, Sharon Maher and Ciara Cahill from IAHFN who look at Heart failure mangement medical and non-medical in the Irish healthcare system on page 35 and Mr Sadiq Siddiqui and Mr Ronan Kelly on page 39 with an overview of Endoscopic Vessel Harvesting for Coronary Artery Bypass Grafts Surgery.
I hope you enjoy the issue.
St John of God Hospital Renamed
St John of God Hospital has signed a landmark Memorandum of Understanding (MOU) with UCD School of Medicine and the hospital has been officially renamed St John of God University Hospital from this month. This agreement establishes St John of God University Hospital as an educational affiliate of University College Dublin (UCD) and sets out the hospital’s role in delivering psychiatry clinical placements for both
undergraduate and graduateentry medical students. The MOU reinforces St John of God University Hospital’s longstanding commitment to medical education, reflecting its role as a teaching hospital over many decades. The agreement represents a renewed dedication to deepening collaboration between the hospital and UCD.
This academic partnership also underlines the Hospital’s contribution to education and
professional development of doctors, nurses, and a wide range of healthcare practitioners.
Speaking at the signing of the MOU, Professor Jennifer Hoblyn, Clinical Director at St John of God University Hospital, said, “The Memorandum of Understanding represents a pivotal step forward in medical education. By partnering with UCD, we hope to continue providing valuable opportunities to students but also support our own model of care at St John
Professor Michael Keane, Professor of Medicine and Therapeutics at UCD, Professor Jennifer Hoblyn, Clinical Director at St John of God University Hospital, Professor Brian O 'Donoghue, Professor of Adult Psychiatry at UCD, and Damien O'Dowd, Chief Executive of St John of God University Hospital
of God University Hospital through fresh perspectives and academic collaboration.’’
Damien O’Dowd, Chief Executive of St John of God University Hospital, added, “We are delighted to be here today to sign this MOU. This agreement reflects St John of God University Hospital’s longstanding commitment to medical education and professional development. This collaboration strengthens our position as a leader in both psychiatric care and education.’’
The MOU between St John of God University Hospital and UCD establishes a comprehensive clinical education programme where students will engage in eight structured rotational placements at the hospital between April and November. These placements are designed to develop the students’ clinical skills, allowing them to take psychiatric histories, attend ward rounds and clinics and build an understanding of common acute and chronic mental health presentations within inpatient and community settings.
Calls for Key Amendments to Mental Health Bill
The Irish Hospital Consultants Association (IHCA) has launched its position paper outlining concerns and a number of strategic considerations in relation to key elements of the recently published Mental Health Bill 2024.
The IHCA strongly supports the Minister of State for Mental Health and Older People, Mary Butler, in reforming mental health legislation. The IHCA engaged constructively with the previous Joint Committee on Mental Health, providing a detailed submission to the PreLegislative Scrutiny of the General Scheme of the Bill.
While many of the Association’s contributions are reflected in the
published draft Bill, the IHCA believes that several critical amendments and considerations are needed in order to ensure effective and timely care to those who need it most, who can be among the most vulnerable people in society.
Launching the position paper, IHCA Vice President and Consultant Psychiatrist Professor Anne Doherty said, “While we welcome the broad principles of the Mental Health Bill, we, as an Association, have some concerns in relation to ensuring that legislation is workable in practice so that patients can access services in a timely and carefocused manner.
“We are keen to see these elements within the Bill addressed as a priority to mitigate against impractical legislation which may only serve to create barriers to treatment and result in an overdependence on the intervention of the State for patient care. We are concerned that if left unchecked, the legislation will undermine the patient’s Right to Treatment in a timely and careoriented manner.
Overall, the IHCA remains committed to constructive engagement with the Department of Health and Minister Butler on legislation that can transform psychiatric care in Ireland,
bringing it in line with international best practice.
“We commend the efforts of the Department of Health to enact positive change in this extraordinarily difficult area of health policy and are keen to see a sustainable framework implemented that avoids delays in treatment and excessive legal burdens and costs being placed on patients within the context of parallel legal processes. Consultant Psychiatrists will accordingly need to allocate additional time to dealing with legal and procedural processes, rather than providing urgent care to patients in an already strained system.
Flexible Training for Doctors ‘Consistently Low’
Recent Medical Council data notes that just 1% of doctors in specialist training programmes availed of Flexible Training during 2022 – 2023. The Medical Council’s 2024 Quantitative Annual Returns show that uptake of Flexible Training, which can allow doctors on the Trainee Specialist Register to undertake part-time or less than full- time medical training, is consistently low.
Flexible training schemes are designed to accommodate doctors who have personal or professional commitments that make full-time training difficult. These schemes allow doctors to work less than full-time while still completing their training and progressing in their careers.
Ahead of International Women’s Day, Medical Council President, Dr Suzanne Crowe, called on doctors to support each other, as well as for established doctors to support and mentor younger doctors who wish to undertake specialist medical training
Dr Crowe acknowledged the challenges faced by trainee doctors in Ireland, “I would encourage doctors in specialist training programmes to seek information on flexible options if they are struggling currently. Resources are available, but more encouragement and mentorship among doctors is also needed.
“Flexible training can be a useful option for doctors who may have caring responsibilities, who prefer
Medical Council President, Dr Suzanne Crowe
to train in a part time capacity, or who desire a better work-life balance. Our research shows that doctors continue to leave the Register each year for reasons such as burnout and lack of flexibility.
“Women can bring a unique understanding of women’s health issues, paving the way for change in medicine, and helping other patients to feel safe and heard. I often speak about the fact that doctors who have familial and care priorities at home need greater flexibility and work arrangements. These are essential components in ensuring we retain our doctors in Ireland.”
Dr Suzanne Crowe also noted the recent progress that has been made to improve equitable access to medical treatment for women, “Medicine is a caring profession, but training has historically been gendered or male focused. I’m pleased to see that this week, Minister for Health, Jennifer Carroll MacNeill, TD led the launch of Women’s Health Week 2025, which affirms the Department of Health’s commitment to driving continued progress across all aspects of healthcare to ensure an equitable service for everyone.
Calls for Criteria-Led Discharging
The Irish Hospital Consultants Association (IHCA) is calling for the widespread implementation of Criteria-Led Discharging (CLD) across Irish hospitals to improve patient flow, reduce delays, and ease hospital overcrowding.
CLD is a structured process that allows pre-approved patients to be discharged from hospital once they meet specific evidence-based clinical criteria, rather than relying solely on the admitting Consultant to make the decision. Instead, Non-Consultant Hospital Doctors (NCHDs), nurses, or Health and Social Care Professionals (HSCPs) can oversee the discharge once all pre-agreed criteria set by the medical team are met.
Despite increased government investment and staffing
improvements, hospitals are facing record levels of demand, with inpatient activity rising by 73,000 admissions last year alone, with 72% of these admissions coming through emergency care. According to the IHCA, smarter, more efficient discharge processes—such as CLD—are essential to ensuring timely access to care.
CLD has been used effectively in other healthcare systems, including the NHS, where studies show it increases weekend discharge rates by 55% and reduces overall hospital length of stay. A structured, predictable discharge process also benefits patients and their families, allowing them to plan for recovery at home.
IHCA President, Professor Gabrielle Colleran, said, "Despite increased funding and reforms, hospitals continue to face record levels of demand. An ageing population and rising chronic disease levels mean this pressure is unlikely to ease anytime soon.
"While continuous investment and staffing are critical, we must also optimise how our hospital teams work. Criteria-Led Discharging is a proven, safe practice that can help reduce unnecessary delays and improve patient care.
"We have an opportunity to build on recent progress in reducing waiting lists and increasing hospital capacity. Implementing CLD as standard practice across every hospital would be
“Since the launch of the first Women’s Health Action Plan three years ago, I have been pleased to see initiatives such as specialist endometriosis teams, the opening of more ambulatory gynaecology clinics, and treatments focusing on prevention and early intervention initiatives for cardiovascular and bone health, aimed at women in midlife and older. There is no one size fits all model of care, and for women to live longer, healthier lives; genderspecific healthcare is essential”, Dr Crowe concluded.
a significant step towards a more efficient, patient-centred hospital system.
"CLD is not a new concept. It dates back to the 1990s and has been recommended in multiple HSE policy documents. It was also part of discussions over the transfer of tasks from doctors to nurses under the Haddington Road Agreement. Yet, a decade later, its implementation remains inconsistent. We have never been in a stronger position to fully implement it.
"While CLD is not a silver bullet, its widespread adoption is a necessary step in addressing emergency care bottlenecks and hospital congestion."
Major Step Forward in Lung Cancer Detection
A major step forward in the early detection of lung cancer has been taken with the launch of the Beaumont RCSI Irish Cancer Society Lung Health Check, a first-of-its-kind pilot clinical trial in Ireland.
Funded by the Irish Cancer Society, this initiative will bring lifesaving lung health checks directly into the communities of North Dublin and the North East through mobile scanning units.
Lung cancer is the leading cause of cancer-related deaths in Ireland, claiming more lives than breast, prostate, and colorectal cancer combined. Early detection is key to improving survival rates, and this initiative is designed to identify lung cancer
and other lung conditions before symptoms appear.
The Lung Health Check, supported by the EU4Health SOLACE consortium and the Department of Health’s Women’s Health Fund, will invite highrisk individuals in selected GP practices, beginning with the Centric Health network in North Dublin and the North-East region to attend a lung health check at a mobile scanning unit. This service, operated by Alliance Medical Diagnostic Imaging, will be based in local GAA clubs, including Croke Park, bringing convenient screening to community locations for those invited.
In Ireland, around 60% of people diagnosed with lung cancer are
Pictured (-r): Professor Daniel Ryan, Respiratory Consultant at the Beaumont RCSI Cancer Centre; Averil Power, CEO of the Irish Cancer Society; Professor Jarushka Naidoo, Professor of Medical Oncology and Consultant Medical Oncologist, Beaumont RCSI Cancer Centre; and Professor Patrick Redmond, Head of RCSI Department of General Practice at the launch of the Beaumont RCSI Irish Cancer Society Lung Health Check
public support in advancing cancer research and care.
Professor Daniel Ryan, Respiratory Consultant at the Beaumont RCSI Cancer Centre and Clinical Lead of the Lung Health Check pilot, said, “Having a mobile lung health check in the community is a major step forward for lung cancer care in Ireland, and we are proud to be leading this work. If you receive an invitation, I strongly encourage you to take part. A simple scan could make all the difference – catching lung cancer early can greatly improve outcomes.
detected at a later stage, when treatment options are more limited. However, introducing lung health checks for high-risk individuals using low dose CT scans has been shown to reduce lung cancer mortality by at least 20%.
International evidence has found that the vast majority (80%) of patients diagnosed through similar programmes have early-stage lung cancer, when treatment is most effective and offers the best chance of cure.
This initiative is part of the ¤4.9 million Beaumont RCSI Irish Cancer Society Lung Outreach Programme, the largest single investment in lung cancer in Ireland’s history. It is led by consultant medical oncologist Professor Jarushka Naidoo. The announcement comes ahead of the Irish Cancer Society’s Daffodil Day on 28 March, highlighting the importance of
New Hub for Medical Research
HSE CEO Bernard Gloster has opened the first of the HSE’s new regional Research Directorates, at St Camillus’ Hospital Limerick, hailing the initiative as a key HSE commitment to advancing the delivery of modern healthcare.
“The best medical care in the world,” he said, “is built upon the latest scientific knowledge, and this knowledge is constantly being added to through research. Healthcare research makes new discoveries, it drives improvement, it makes treatments more effective and processes more efficient. Whether its focus is on technology, surgery, medicine or the patient experience, research helps improve health and social
care for our patients and clients, and the HSE, through its Regional Directorates, is committed to supporting research and embedding it across our services.”
The Research Directorate Mid West, led by Prof Declan Lyons, will oversee all aspects of clinical research within the HSE locally, with the aim of promoting the advance of scientific knowledge and medical treatments.
As a single point of entry for healthcare researchers in the region, the Directorate will streamline researchers’ access to professional advice, expert regulatory support, and the infrastructure needed to conduct effective and innovative research.
At the official opening last Friday, March 21, Prof Lyons said the opening of the Directorate was
“An important step for the HSE in driving the research agenda forward. In collaboration with our academic partners, our mission in the Mid West is to facilitate reliable, high quality, and innovative research across a range of fields relevant to the people of the locality”
He cited as an exemplar of such research the recent trial of a comprehensive multidisciplinary assessment of older patients living with frailty who present to the Emergency Department (ED) at University Hospital Limerick. Led
“This pilot is breaking down barriers that have long stood in the way of early detection of lung cancer, bringing together partners across the healthcare system. The support from the Irish Cancer Society, and our collaboration with Centric Health GP practices, Alliance Medical Diagnostic Imaging, and the GAA clubs in the region will ultimately save lives.”
The cutting-edge mobile scanning unit is on-site in Croke Park for the launch today, offering attendees the opportunity to see first-hand how the technology will be used in the community.
The first invitations for the Lung Health Check will be sent by the select GP practices in the coming months with the first participants expected to undergo screening by early summer. The pilot clinical trial will focus on high-risk individuals, particularly current or former smokers, with the aim of assessing the impact of community-based lung health screening in Ireland.
by consultant geriatrician Dr Aoife Leahy, the research identified key benefits for patients, including reduced wait times in ED, fewer hospital admissions, lower rates of ED re-attendance and fewer nursing home admissions. Patients also reported better quality of life and function at 180 days.
Prof Lyons said such studies continue to drive improvement in healthcare, and his vision for the Research Directorate Mid West is to help foster a thriving research culture that enables innovative studies that will impact patient lives locally, nationally and internationally.
SVUH – Top Performing Centre for Rare Lung Disease
Professor Cormac McCarthy, Associate Professor and Consultant Respiratory Physician at SVUH and members of his team proudly unveil the plaque marking their designation as a European Reference Network (ERN) Centre of Expertise for Rare and Complex Diseases
St. Vincent’s University Hospital (SVUH) has been awarded an Excellent rating in the prestigious ERN-LUNG Member Activity Performance Tool (LUNG-MAP) survey, solidifying its position as a leader in rare and complex lung disease care across Europe. As an expert centre for rare lung disease, SVUH has been recognised as one of the leading and highestperforming centres in Europe, rated Excellent by the European Reference Network. SVUH is proud to share this recognition on Rare Disease Day, a global initiative dedicated to raising awareness and improving outcomes for people living with rare conditions. This announcement underscores the hospital’s dedication to delivering world-class care for patients with rare lung diseases, ensuring they benefit from cutting-edge treatment and international collaboration.
The European Reference Network for Rare Respiratory Diseases (ERN-LUNG), made up of 88 centres across Europe, assessed healthcare providers across seven key categories, including Network Activities, Academy, CPMS (Clinical Patient Management System), Registry, Publications, Clinical Trial Network (CTN), and Patient-Related Outcomes (PRO). In health centres all over Europe, SVUH emerged as the topperforming hospital, excelling in all seven categories—a testament to its commitment to clinical excellence, research, and patientcentred care.
Professor Michael Keane, Interim CEO of St. Vincent’s University Hospital, welcomed the recognition, said: “This achievement highlights the dedication of our multidisciplinary teams who work tirelessly to improve the diagnosis, treatment, and care of patients with rare and complex lung diseases. As an integral part of ERN-LUNG, SVUH is ensuring that Irish patients benefit from the highest standard of specialised care, supported by cutting-edge research and international collaboration.”
The European Reference Networks (ERNs) are a flagship initiative of the European Union, designed to connect the best medical expertise across Europe and ensure that knowledge travels to the patient, rather than the other way around. With over 6,000 rare diseases affecting up to 36 million people in the EU, ERNs play a critical role in improving access to high-quality
care, accelerating diagnosis, and enabling cross-border consultations between medical experts.
Professor Cormac McCarthy, Associate Professor and Consultant Respiratory Physician at SVUH, highlighted the significance of this achievement: “SVUH’s recognition as the highest-performing centre in ERNLUNG underscores our dedication to rare lung disease research and care. This distinction means that Irish patients are receiving some of the best rare disease treatment in Europe, right here at home. Our participation in ERN-LUNG enables us to engage in pioneering research, access international expertise, and shape the future of rare lung disease treatment, ultimately improving outcomes for our patients.”
SVUH’s participation in ERN-LUNG allows the hospital to access a secure IT platform where complex patient cases can be discussed by
RCPI Council Elections open for Nominations
expert panels across Europe. This facilitates faster, more accurate diagnoses and ensures patients receive the most advanced treatments available, without the need to travel abroad.
The hospital’s commitment to rare disease care aligns with the broader national and European strategy to integrate ERNs into healthcare systems, ultimately improving outcomes for patients with rare and complex conditions. SVUH collaborates closely with Mater and Beaumont hospitals in Dublin, further strengthening Ireland’s position in rare disease expertise and care.
As Rare Disease Day 2025 shines a light on the millions of people living with rare diseases, SVUH’s recognition as a centre of excellence serves as a powerful reminder of the importance of collaboration, innovation, and patient-centred care in transforming lives.
The Royal College of Physicians of Ireland (RCPI) is holding an election this year to elect five fellows to RCPI Council including two from Medicine, one from Public Health Medicine, one from Pathology, and one from Obstetrics and Gynaecology.
Eligible fellows are invited to submit their nomination using the online form by 4pm (GMT) on Friday, 16 May 2025. Following the nomination period, the voting ballot will open on 29 May 2025.
Further information on the RCPI Council election including eligibility criteria, role description and Council terms of reference is available on the website by going to www.rcpi.ie
The Council is the governing body of the Royal College of Physicians of Ireland. It sets our mission, vision and strategic direction, and approves general policies. Council also ensures the accountability of RCPI by monitoring and supporting the implementation of policies, directives and general functions. Read more about the RCPI Council at https://www.rcpi.ie/About-Us/Our-People/President-and-Council
New Horizons for Biosimilar Medicines Policy
Delivering better access, outcomes, and biotech manufacturing in the future
Europe has historically led the way in biosimilar adoption and policy development enabling biological medicine affordability and access for millions of European patients. A fit for the future biosimilar medicine policy should target broader, transformative opportunities for innovation in healthcare delivery, patient outcomes and technological progress.
Biosimilar medicines have proven their health value, generating nearly 7 billion patient treatment days of safe clinical use while contributing to the sustainability and resilience of healthcare systems with more than ¤56 billion in cumulated savings since 2006.
The four future opportunities for biosimilar medicine policies in Europe are:
1. Availability, Affordability and Accessibility: Future-proof the regulatory review process in-line
with science and experience, drive competition at loss of exclusivity, and encourage multisource competition and supply in the market.
2. Advancing Care and Outcomes for Patients: Financial savings from the use of biosimilar medicines are a means to drive more efficient healthcare delivery for patients. Biosimilar policies should include re-investment and benefit sharing strategies aimed at improving overall patient care to further reduce the impact of non-communicable diseases on patients’ lives. This will allow people to live productive lives and stimulate the economy.
3. Innovation along Care Pathways: take advantage of affordable biological treatment to reshape treatment and care pathways for patient benefit. Build on the pharmaceutical legislation and health strategy
reform to explore untapped therapeutic potential through new combination therapies or repurposing in new indications.
4. Stronger EU Global Leadership: Europe is wellpositioned to lead on the next generation of biosimilar medicines. The EU Biotech Act should spur investments in new technologies and innovation in product and process development by focusing on industrial know-how to ensure its competitive advantage on the global stage.
Speaking at Medicines for Europe’s BIOS25 conference in Amsterdam, Sector Group Chair Isabell Remus said, “Biosimilar medicines have revolutionised the availability and cost-efficiency of biological therapies across Europe. Our industry now provides access to new, lifesaving and life-enhancing medicines to
patients across the region, while also representing a cornerstone of Europe’s biotech economy that drives next-generation technologies, digital solutions, and sustainable practices.
“Yet there is more to do, particularly in using biosimilars to reshape European healthcare delivery. This will require removal of the default but unnecessary clinical efficacy studies, reform of EU procurement laws, and investment in the EU biosimilar ecosystem in preparation for the loss of exclusivity on the next generation of biological medicines – as well as support for biosimilar R&D and manufacturing in Europe. These steps, alongside the potential offered by the EU Biotech Act, will ensure the biosimilar sector continues to thrive in Europe for the benefit of patients and healthcare systems.”
Professor Wang wins 2025 NovaUCD Innovation Award
A leading skin and wound healing research expert, Professor Wang focuses on areas of biomaterials, stem cell and gene therapy for the treatments of skin wounds, and cartilage and bone regeneration.
Professor Wang’s intellectual property portfolio includes 12 invention disclosures to NovaUCD, being a named
inventor on more than 30 patents, and launching and commercialising multiple developed technologies onto the market.
He is also the founder of three start-up companies, including Vornia, Bláfar and Branca Bunús, a UCD spin-out biotech company.
UCD is committed to delivering impact from our leading research and innovation across a broad range of disciplines
Branca Bunús develops and commercialises therapies for patients suffering from genetic disorders.
“I am delighted to receive this award from NovaUCD – my dream and passion is translating my
scientific discovery into realworld applications to benefit humankind,” said Professor Wang.
“In the years ahead I will keep pursuing this life mission of mine.”
The NovaUCD Innovation Award recognises excellence in innovation and of successes achieved in the commercialisation of UCD research or other intellectual activity over several years.
A total of seven awards were presented by Professor Orla Feely, President of UCD.
“UCD is committed to delivering impact from our leading research and innovation across a broad range of disciplines,” said Professor Feely.
“The NovaUCD Innovation Awards, which have become a key annual event, recognise the achievements of our research, innovation and entrepreneurial communities and demonstrate our strength in developing talent and creating and applying knowledge to deliver impact.”
Professor Wenxin Wang
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Achieving Equity and Excellence: The National Immunisation Office Strategic Plan 2024-2027
Ensuring equitable access to immunisation and strengthening vaccine programmes are critical to protecting public health in Ireland. The National Immunisation Office (NIO) Strategic Plan 2024-2027 sets out a targeted approach to enhancing immunisation services, addressing emerging challenges, and supporting healthcare professionals in delivering high quality, evidence based vaccination programmes. With a focus on collaboration, innovation, and equity, the strategy outlines key priorities to improve vaccine uptake, align immunisation governance structures, and strengthen preparedness for emerging infectious threats.
Strengthening Immunisation in Clinical and Hospital Settings
Immunisation remains one of the most effective public health interventions, with significant implications for hospital professionals. The COVID-19 pandemic underscored the importance of strong vaccination strategies, showcasing both successes in uptake and areas requiring continued attention. However, challenges persist, including declining childhood immunisation rates, the emergence of new infectious threats, and pressures on the healthcare
Written by Dr Lucy Jessop, Director, National Immunisation Office
system. The strategy underscores the importance of collaboration with healthcare providers across all sectors to enhance vaccine access, address coverage gaps, and improve immunisation uptake.
Strategic Priorities for Healthcare Professionals
The 2024-2027 plan focuses on six core objectives, each addressing key areas of vaccine administration and public health protection:
1. Enhancing Childhood Immunisations: Achieving a 95% uptake of routine childhood vaccines is a national priority to prevent outbreaks of vaccine preventable diseases. Healthcare professionals play a crucial role in identifying under immunised patients, supporting catch up vaccination efforts, and promoting vaccine confidence among families.
2. Improving School Based Vaccination Programmes: Strengthening the uptake of school delivered vaccines, including HPV and flu vaccines, is essential to meeting WHO targets for disease prevention. The strategy focuses on maximising vaccine access and ensuring equitable delivery across all regions.
3. Optimising Adult Immunisation Strategies: Hospital based healthcare professionals are central to protecting vulnerable populations, including older adults, pregnant individuals, and those with chronic conditions. The strategy aims to increase influenza vaccine uptake to 75% in eligible groups and explore opportunities to enhance immunisation efforts for high risk populations such as gay bisexual Men who have sex with Men (gbMSM) in the LGBTQIA+ community.
4. Integrating COVID-19 Vaccination into Routine Care: While COVID-19 is no longer classified as a public health emergency, it remains a significant concern. The NIO Strategic Plan aims to align COVID-19 vaccination with routine immunisation structures where possible, ensuring continued access for at risk groups and supporting healthcare workers in maintaining vaccine uptake.
5. Enhancing Preparedness for Emerging Infectious Threats: The COVID-19 pandemic highlighted the need for strengthened vaccination systems and preparedness strategies. The NIO Strategic Plan emphasises a proactive approach to infectious disease threats, including Mpox and future novel pathogens, through robust surveillance, effective vaccine distribution, and coordinated public health responses.
6. Leveraging Data and Technology for Informed Immunisation Planning: Access to accurate and timely immunisation data is critical for public health decision making. The development of the National Immunisation Information System (NIIS) will enhance real-time tracking of vaccine coverage, facilitate targeted interventions, and support evidence based policy development.
Equity and Collaboration in Vaccine Delivery
Collaboration is fundamental to delivering effective immunisation programmes. The engagement of
hospital staff, general practitioners, nurses, and pharmacists plays a vital role in both vaccine administration and promotion of and increasing public trust in immunisations. The NIO is committed to supporting healthcare providers with clear, evidence based guidance and training to improve vaccine confidence and counter misinformation.
A Call to Action for Hospital Professionals
As Ireland strengthens its immunisation programmes, healthcare professionals across hospital and community settings play a critical role in supporting vaccine uptake and public confidence. By ensuring vaccines are accessible, addressing patient’s questions, and integrating immunisation into routine care where appropriate, healthcare providers contribute to a strong and equitable immunisation system. The NIO remains committed to providing evidence based guidance and resources to support these efforts, including training on how to speak to people about immunisations using motivational interviewing.
For further details, access the full National Immunisation Office Strategic Plan 2024-2027 at www.immunisation.ie.
HSE National Immunisation Office have a new eLearning course 'Talking About Immunisation' to support health professionals and vaccine advocates. The course provides an understanding of how to effectively communicate with people who may be hesitant about vaccinations. Visit: http://hseland.ie
European Immunisation Week, taking place on April 27th, is an opportunity for healthcare professionals to advocate for vaccines and raise awareness about their importance. This year, hospital staff can support the week by engaging with our social media channels and sharing content from our #HumanlyPossible campaign.
Social Media: @hseimm on Twitter & Instagram | National Immunisation Office on YouTube
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'Diabetes in Ireland' Conference 2025 is incorporating all areas in:
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About the programme
O n e v e n u e , f o u r s t r e a m s a n d a n e x c e p t i o n a l c o n f e r e n c e e x p e r i e n c e .
O n e v e n u e , f o u r s t r e a m s a n d a n e x c e p t i o n a l c o n f e r e n c e e x p e r i e n c e .
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About the programme
About the programme
n a t i o n a l a n d i n t e r n a t i o n a l d i a b e t e s e x p e r t s o n d i a b e t e s r e s e a r c h , d i a b e t e s t e c h n o l o g y , a c c e s s a n d m o r e , k e
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w h a t i s h a p p e n i n g i n d i a b e t e s c a r e i n I r e
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w h a t i s h a p p e n i n g i n d i a b e t e s c a r e i n I r e l a n d . L i g h t l u n c h w i t h t ea a n d c o f f e e w i l l b e p r o v i d e d .
Cost Implication of UWWTD on Medicines
Medicines for Ireland (MFI) has warned about the devastating impact of the cost of implementation of the Urban Wastewater Treatment Directive (UWWTD) on the supply of the majority of medicines for Irish patients.
The warning comes after several generic medicines suppliers, supported by Medicines for Europe, filed a legal case with the Court of Justice of the European Union against the creation of an Extended Producer Responsibility (EPR) scheme under the Urban Wastewater Treatment Directive (UWWTD). The legal action seeks to avoid a discriminatory and disproportionate cost burden on generic medicines, therefore safeguarding patient access to vital medicines.
Generic medicines are the mainstay of most patients medicine cabinets, they generally are the lowest cost medications, representing nearly 60 per cent of all prescriptions in 2023. As such, it’s anticipated that
generic medicine suppliers may be expected to shoulder the bulk of the financial cost under the EPR scheme for removing micropollutants from urban wastewater. This fails to recognise the extremely tight margins given the pricing models for generic medicines.
Donagh O’Leary, chair of the MFI UWWTD working group said: “Based on the modelling conducted by our colleagues in Medicines for Europe, the real impact of the UWWTD will lead to a tsunami of medicine shortages. We are extremely concerned that the UWWTD will place disproportionate financial and operational burdens on the generic pharmaceutical industry, hindering the supply of medicines to millions of Irish patients.”
“The directive’s flawed Extended Producer Responsibility (EPR) system unfairly targets pharmaceutical companies, forcing them to cover the lion’s share of costs for removing residues from wastewater. We know that these
residues originate from many other sectors beyond pharma and the establishment of an EPR under the Directive must recognise this to spread the cost fairly. We are urgently calling for the Commission to undertake a new impact assessment. In addition, an urgent reviewof the UWWTD is needed to ensure patient access to essential medicines is not burdened by cost.”
The European Commission estimates ¤1.2 billion annually for EU-wide Extended Producer Responsibility (EPR) in its impact assessment. However, the feasibility study used for the impact assessment only assessed 12 molecules, of which hazardousness data was not available for 7 of them. This is not a reliable sample for the thousands of pharmaceutical molecules.
National regulators and the water industry have estimated much higher costs than the European Commissions. For example, the German Environment Agency estimates costs for Germany
Advancing Clinical Trial Science
University of Galway has announced the appointment of Dr Tom Melvin as an Associate Professor to support its mission of advancing clinical trial methodologies and regulatory science.
The appointment of Dr Melvin a globally recognised expert in medical device regulation, will enhance the Institute for Clinical Trial’s collaboration with the medtech industry,
supporting innovation and the development of safe, effective medical technologies.
Through his expertise, Dr Melvin will provide strategic guidance on regulatory pathways, ensuring that cutting-edge medical devices can reach patients efficiently while maintaining the highest safety and ethical standards.
Launched in 2023, the Institute for Clinical Trials is dedicated
Associate Professor Tom Melvin with Professor Fidelma Dunne, Director of the Institute for Clinical Trials at University of Galway
alone at ¤885 million – ¤1.025 billion annually, nearly four times the Commission’s projection of ¤238 million. EurEau estimates annual per capita costs at ¤8 –¤25, translating to EU-wide costs of up to ¤11.3 billion annually. These discrepancies highlight the need for accurate cost assessments to avoid jeopardising medicine supply.
Mr O’Leary concluded: “MFI and our colleagues in Medicines for Europe fully support initiatives to improve environmental sustainability. However, while the EPR framework claims to encourage the development of “greener” medicines, it fails to recognise the complexities of pharmaceutical design, where reformulation is often impractical without compromising the safety and effectiveness of the medicine. MFI remains committed to working with all stakeholders to develop practical and sustainable solutions that safeguard the environment and patient access to essential medicines.”
to transforming how clinical trials are designed, conducted and translated into practice, with a strong focus on industry partnerships, education and regulatory leadership.
Professor Melvin said, “I am delighted to be joining University of Galway’s Institute for Clinical Trials - a place where operational and scientific excellence drive the ambition to rapidly translate research into impact. The
translational development of a new medical technology is a complex journey that has become more challenging as a result of the revised framework for the regulation of medical devices in Europe.
“The Institute for Clinical Trials is playing a vital role in supporting developers to translate their technology from idea and prototype to first clinical use. I look forward to providing support to medical technology developers, and to engage in research to develop improved methodological approaches for the evaluation of medical technologies.”
Professor Fidelma Dunne, Director of the Institute for Clinical Trials at University of Galway, said: “Dr Melvin’s expertise in medical device regulation will be invaluable to the Institute for Clinical Trials at University of Galway. His appointment strengthens our position as a leader in clinical trials and regulatory science, reinforcing our role in supporting industry and academic partners in bringing new innovations to patients.”
GO BEYOND LOWERING LDL-C
ADD ON TO REDUCE CV RISK
When statins* and ezetimibe are not enough, add on once daily oral bempedoic acid earlier, to help your patients go even further.1,2Δ ® ®
* Concomitant use with simvastatin >40 mg daily is contraindicated; please refer to the relevant SmPC for more information.1,2
Δ NILEMDO® and NUSTENDI® are indicated in adults with established, or at high risk for, ASCVD to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors, who are on maximally-tolerated statins, or statin-intolerant, or statin-contraindicated with or without ezetimibe or not adequately controlled with ezetimibe treatment.1,2
Abbreviated Prescribing Information Refer to Summary of Product Characteristics (SmPC) prior to prescribing.
Presentation: Each Nilemdo film-coated tablet contains 180 mg bempedoic acid. Each Nustendi film-coated tablet contains 180 mg of bempedoic acid and 10 mg of ezetimibe. Indications: Hypercholesterolaemia and mixed dyslipidaemia: Nilemdo/Nustendi are indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet: In combination with a statin (Nilemdo: or statin with other lipid-lowering therapies) in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin; alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant; or for whom a statin is contraindicated (Nustendi: and are unable to reach LDL-C goals with ezetimibe alone). Cardiovascular disease: In adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in patients on a maximum tolerated dose of a statin with or without ezetimibe or; alone in patients who are either statin-intolerant, or for whom a statin is contraindicated (Nustendi: or in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.) Posology and method of administration: The recommended dose is one tablet of 180 mg Nilemdo or 180 mg/10 mg Nustendi taken once daily, with or without food. Tablet should be swallowed whole. Concomitant simvastatin therapy: When Nilemdo/Nustendi are co-administered with simvastatin, simvastatin dose should be limited to 20 mg daily (or 40 mg daily for patients with severe hypercholesterolaemia and high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks). Coadministration with bile acid sequestrants: Dosing of Nustendi should occur either at least 2 hours before or at least 4 hours after administration of a bile acid sequestrant.
Paediatric Population: The safety and efficacy of Nilemdo/Nustendi in children aged less than 18 years have not yet been established. Contraindications: Hypersensitivity to the active substance or any of the excipients (see SmPC); pregnancy; breast-feeding; concomitant use with simvastatin > 40 mg daily. When Nustendi is co-administered with statin in patients with active liver disease or unexplained persistent elevations in serum transaminases; when Nustendi is co-administered with a statin, consult the SmPC for that particular statin therapy. Warnings and precautions: Potential risk of myopathy with concomitant statins: Bempedoic acid increases plasma concentrations of statins. Patients receiving Nilemdo and a statin should be monitored for adverse reactions that are associated with high doses of statins. Statins occasionally cause myopathy. In rare cases, myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria and can lead to fatality. In post marketing experience with ezetimibe, very rare cases of myopathy and rhabdomyolysis were reported. Most patients who developed rhabdomyolysis were taking a statin with ezetimibe. Patients receiving Nilemdo/Nustendi and a statin should be advised of the potential increased risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness. If such symptoms occur, a lower maximum dose of the same statin or an alternative statin, or discontinuation of Nilemdo/Nustendi and initiation of an alternative lipid-lowering therapy should be considered under close monitoring of lipid levels and adverse reactions. If myopathy is confirmed by creatine phosphokinase (CPK) > 10× upper limit of normal (ULN), immediately discontinue Nilemdo/ Nustendi and any statin. Increased serum uric acid: Bempedoic acid may raise serum uric acid due to inhibition of renal tubular OAT2 and may cause or exacerbate hyperuricaemia and precipitate gout in patients with history of gout or predisposed to gout. Discontinue Nilemdo/Nustendi if hyperuricaemia accompanied with symptoms of gout appear. Elevated liver enzymes: Liver function tests should be performed at initiation of therapy. Discontinue Nilemdo/Nustendi if increase in transaminases > 3× ULN
persists. Renal impairment: Additional monitoring for adverse reactions may be warranted in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) or patients with ESRD on dialysis. Hepatic impairment: Periodic liver function tests should be considered for patients with severe hepatic impairment (Child-Pugh C) taking Nilemdo. Nustendi is not recommended in moderate to severe hepatic impairment (Child-Pugh B and C) due to unknown effects of increased exposure to ezetimibe. Fibrates: If cholelithiasis is suspected in a patient receiving Nustendi and fenofibrate, gallbladder investigations are indicated, and therapy should be discontinued. Ciclosporin: Caution when initiating Nustendi in the setting of ciclosporin. Ciclosporin concentrations should be monitored. Anticoagulants: Appropriately monitor INR if Nustendi is added to warfarin, other coumarin anticoagulants, or fluindione. Contraception measures in women of child-bearing potential: Before initiating treatment in women of child-bearing potential appropriate advice on effective methods of contraception should be provided, and effective contraception initiated. Patients taking oestrogen-based oral contraceptives should be advised to stop Nilemdo/Nustendi before stopping contraceptive measures if planning to become pregnant. Excipients: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Nilemdo/Nustendi as it contains lactose. Patients at high risk of cardiovascular disease: Evidence for the use of the fixed combination medicinal product of bempedoic acid with ezetimibe in patients at high risk of cardiovascular disease is only available for the lipid-lowering effect in absence of any cardiovascular risk reduction estimation for ezetimibe in primary prevention patients. Driving and use of machines: Nustendi has minor influence on ability to drive and use machines. Dizziness has been reported. Interaction with other medicinal products: Refer to SmPC for full information on interactions. Adverse reactions: Nilemdo: Common (≥ 1/100 to < 1/10): Glomerular filtration rate decreased, anaemia, gout, hyperuricaemia (includes blood uric acid increased), AST increased, pain in extremity. Uncommon (≥ 1/1,000 to < 1/100): weight decreased, haemoglobin decreased, ALT increased, liver function test increased, blood creatinine increased, blood urea increased, Consult Nilemdo SmPC in relation to other adverse reactions. Nustendi: Common (≥ 1/100 to < 1/10): Glomerular filtration rate decreased, anaemia, decreased haemoglobin, hyperuricaemia (includes uric acid increased), decreased appetite, dizziness, headache, hypertension, cough, constipation diarrhoea, abdominal pain, nausea, dry mouth, flatulence, gastritis, liver function test increased (includes liver function test abnormal), back pain, muscle spasms, myalgia, pain in extremity, arthralgia, blood creatinine increased, fatigue, asthenia, gout, AST increased (for bempedoic acid), blood CPK increased. Uncommon (≥ 1/1,000 to < 1/100): weight decreased, ALT increased, blood urea increased, hot flush, dyspepsia, gastrooesophageal reflux disease, AST increased (for ezetimibe), GGT increased, pruritus (with statin), neck pain, muscular weakness (with statin), chest pain, pain, oedema peripheral (with statin). Frequency not known: Thrombocytopaenia, hypersensitivity (including rash, urticaria, anaphylaxis, angio-oedema), depression, paraesthesia (with statin), dyspnoea, pancreatitis, hepatitis, cholelithiasis, cholecystitis, erythema multiform, myopathy / rhabdomyolysis. Consult Nustendi SmPC in relation to other adverse reactions. Legal Classification: POM. Package quantity, marketing authorisation (MA) number: Nilemdo 28 tablets: EU/1/20/1425/002. Nustendi 28 tablets: EU/1/20/1424/002. MA Holder: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany. Further information available on request from Daiichi Sankyo Ireland Ltd. D09 YF97. Telephone: (01) 489 3000. Fax: (01) 489 3033. Email: medinfo@daiichi-sankyo.ie Date of Preparation: December 2024. JOB ID: IE/BEM/12/24/0005.
Healthcare professionals are asked to report any suspected adverse reactions via the HPRA Pharmacovigilance, Website: www.hpra.ie. Adverse events or a product complaint about a Daiichi Sankyo medicine can also be directly reported to Daiichi Sankyo Ireland Ltd. D09 YF97 by telephone: +353 (1) 4893000.
References: 1. NILEMDO®. Summary of Product Characteristics. Available from: https://www.medicines.ie/medicines/nilemdo-180mg-film-coated-tablets-36336/spc [Accessed December 2024]. 2. NUSTENDI®. Summary of Product Characteristics. Available from: https://www.medicines.ie/medicines/nustendi-180mg-10mg-film-coated-tablets-36337/spc [Accessed Date: December 2024] IE/BEM/12/24/0002 | Date of preparation: January 2025
Mater Private Network Annual Heart Summit
Mater Private Network hosted its annual Dublin Heart Summit recently at the Royal College of Surgeons in Ireland (RCSI), welcoming over 700 cardiologists, GPs and other healthcare professionals to discuss the latest developments in patient care.
Now in its second year, the Dublin Heart Summit is organised by Mater Private Network and the Cardiovascular Research Institute (CVRI) Dublin and supported by RCSI and the Irish Cardiac Society. It aims to foster collaboration and inspire fresh approaches to improving patient outcomes in cardiovascular medicine.
This year’s programme included expert-led discussions on emerging treatments and innovative technologies, evolving models of care, and spotlights
Ireland’s potential to strengthen its position as a global leader in heart health.
Highlights included a keynote address from Professor Valentin Fuster of Mount Sinai, USA, and the National Centre for Cardiovascular Investigation, Spain, who spoke on the changing landscape of health and disease, with a focus on technology and education.
Other sessions featured leading international and national experts to explore a wide range of topics, including recent developments in the treatment of heart failure, coronary artery disease, cardiooncology, the link between menopause and heart health, and the role of exercise as a form of cardiovascular medicine.
Professor Robert Byrne, Director of Cardiology at Mater Private Network and Professor of Cardiovascular research at RCSI with Professor Valentin Fuster of Mount Sinai, USA
Speaking about the importance of the Dublin Heart Summit, Professor Robert Byrne, Director of Cardiology at Mater Private Network and Professor of Cardiovascular research at RCSI, said, "Our vision for the Heart Summit is to create a platform for leading experts from Ireland and abroad to come together, share expertise, and help shape the future of cardiovascular care. Cardiovascular disease remains the leading cause of death and disability among Irish adults, and it's essential that we continue to advance
our approaches to prevention, diagnosis, and treatment.
“As medical and surgical treatments continue to evolve, we have a responsibility to embrace clinical research as part of routine care and to ensure that the latest innovations are made available to our patients in a timely manner. In doing so, we not only enhance patient outcomes here in Ireland, but also contribute to the global advancement of cardiovascular medicine."
With more than 700 healthcare professionals in attendance both virtually and in person, Mater Private Network is dedicated to advancing excellence and innovation in cardiac care in Ireland by hosting educational sessions like the Dublin Heart Summit.
Irish Life Health announces new Managing Director
Irish Life Health has announced that Ann Marie Nestor will become Managing Director of the business, succeeding Ger Davis.
Ann Marie has been with Irish Life Health since 2023, as Director of Finance, Planning & Risk. She has over two decades of experience in financial services and insurance industry, the majority spent with Canada Life Assurance Europe where she held roles including Head of Product Development, and Chief Risk Officer.
Ann Marie will be a key member of the leadership team of the Insurance and Financial Services division within the Irish Life Group, which will be led by Ger Davis in his new capacity as Managing Director, Insurance and Financial Solutions.
Within Irish Life, Ann Marie is Executive Sponsor of the Ethnicity & Multiculturalism Employee Resource Group (ERG), where she has led initiatives that promote a more inclusive workplace, and partnering with networks that promote talent from diverse backgrounds.
Ann Marie Nestor, Managing Director, Irish Life Health, said: "I am very pleased to take on this leadership position for Irish Life Health during this important time for the health insurance industry in Ireland. Above all, I look forward to working with the team as we continue to deliver and innovate for our customers. My focus will be on ensuring that our customers continue to receive best-in-class health insurance and an innovative product offering that evolves with their needs, while also ensuring we drive strong value for money.”
Ann Marie Nesto
Professor Valentin Fuster of Mount Sinai, USA
Supporting Positive Mental Health
A team from the Centre for Positive Health Sciences at RCSI University of Medicine and Health Sciences led by Dr Jolanta Burke has partnered up with organisations across five EU countries and secured €5.5 million in funding from the Interreg EU programme for an initiative aimed at developing innovative forest-based tools to support adolescents and their families in improving and maintaining their positive health.
The RCSI Centre for Positive Health Sciences team, Dr Jolanta Burke (Principal Investigator), Dr Elaine Byrne, Dr Mary Clarke, Prof. Christian van Nieuwerburgh and PhD Candidates Kate Brassington and Branislav Kaleta, will be involved in this four-year project. Their work will focus on codesigning a series of forest-based psychological interventions (real-life and virtual reality) that mental health professionals, young people, and their families can engage with to enhance adolescent health and well-being. They will also explore how foresters can adapt Irish forests to create more welcoming environments for young people. By the end of the project, this initiative will deliver a suite of innovative solutions designed to deepen adolescents’ engagement with nature, helping to safeguard them against anxiety, depression, and other mental health challenges
as well as improving their psychological, emotional and social well-being.
Dr Jolanta Burke said: "Many young people are struggling, and our research with nearly 3,000 students reveals a concerning decline in wellbeing as adolescents progress through their education. A cost-effective way to support them is by connecting them with the natural resources of nearby forests, encouraging them to embrace their restorative benefits from an early age. This project has the potential to transform the lives of many young people living in Ireland and their families. It could make our beautiful forests more inviting to them."
Faced with the mental health problems experienced by adolescents, the Forest4Youth project, co-funded by Opens in new windowInterreg North-WestEurope, is proposing an innovative solution: exploring the therapeutic power of forests to improve teenagers' well-being.
Today, 17.5% of young people in north-western Europe suffer from mental disorders such as depression, anxiety or addiction. Mental health services are struggling to meet this growing demand. It is therefore essential to rethink therapeutic support by integrating varied, more accessible and sustainable approaches.
Dr Jolanta Burke, RCSI Centre for Positive Health Sciences
A natural recovery area
Research shows that forest immersion has a direct and beneficial impact on mental health, particularly on symptoms of depression and anxiety, reducing stress, improving mood and promoting concentration. Yet these natural therapies remain under-exploited.
More than 20% of north-western Europe is covered by natural areas that could be used for the benefit of adolescents living with mental health problems. The Forest4Youth project improves the integration of the forest in therapeutic devices thanks to the following results:
• Identification of pilot therapeutic forests in several European countries.
• The development of a care protocol combining real immersion in the forest and virtual reality.
• Accompanying adolescents in therapeutic forest programmes.
• Training for mental health professionals and foresters.
• The creation of reference training centres.
MSc Clinical Pharmacy Graduations
A transnational approach
Forest4Youth is based on an unprecedented collaboration between mental health professionals and the owners and managers of forests and green spaces. The aim is to develop accessible solutions that can be implemented on a large scale, so that young people can benefit from these therapies.
"Reconnecting teenagers with nature gives them a chance to improve their mental health," explain the project's initiators. The project also calls on public decision-makers to integrate these solutions into health and regional planning policies.
At a time when the mental health of young people is becoming a societal emergency, natural spaces represent a precious and widely available resource: exploiting them for their well-being is a necessity.
Congratulations to the MSc Clinical Pharmacy graduates from the School of Pharmacy at University College Cork, who have celebrated their achievement at the spring conferring ceremony, University College Cork.
The School recognised the following individuals who successfully completed the programme: Caoimhe Bolger, James Crowley, Anne-Marie Doherty, Jane Ensor, Lisa Kehily, Phoebe Kelly, Michael Kilcullen, Rachel MacCarthy, Aoife Maher, James McGuirk, Mary Minehane, Kieran O’Dea, Eve Rodgers, Áine Sweeney.
Caoimhe Bolger received the prize for achieving the highest aggregate score in the programme class 2022-2024.
Jane Ensor received the prize for the best research dissertation in the programme class 2022-2024.
Thank you to McCabe’s Pharmacy, Denis O’Driscoll, and Susan O’Meara for donating the prizes to accompany these awards.
The MSc in Clinical Pharmacy is currently accepting applications for the 2025 September intake. Learn more about the programme and how to apply by visiting www.ucc.ie
Myeloma
Management of Multiple Myeloma
Written
by Prof. John Quinn, Consultant Haematologist & Saad Sharif, Haematology Registrar, Beaumont Hospital
Introduction
Multiple Myeloma (MM) is a haematological disorder characterised by clonal expansion of abnormal plasma cells within the bone marrow. MM represents a significant proportion of haematological malignancies with approximately 380 new cases diagnosed every year in Ireland. The International Myeloma Working Group criteria which was devised in 2014 is used to diagnose MM. This requires >10% clonal bone marrow plasma cells or biopsy-proven extramedullary plasmacytoma alongside one of the following Myeloma Defining Events to make a diagnosis; >60% clonal plasma cells in the bone marrow; a significantly deranged serum free light chain ratio; more than one focal bony lesion ≥5mm in diameter on imaging; CRAB features (Hypercalcaemia, Renal insufficiency, anaemia and bone lesions). While Myeloma is regarded as incurable, the primary goal of treatment is to induce a deep and durable remission which allows patients to achieve prolonged survival until eventual relapse or drug intolerance. In recent years, there has been a great expansion of additional therapeutic options achieving impressive results in relapsed and refractory multiple myeloma (RRMM), conferring excellent progression-free survival (PFS) in many cases.
Monoclonal antibodies –Anti-CD38
One of the most significant breakthroughs in Myeloma treatment has been the addition of
Anti-CD38 monoclonal antibodies (Daratumumab and Isatuximab). These monoclonal antibodies bind to CD38 which is overexpressed in myeloma plasma cells. Daratumumab is given in both induction pre-autologous stem cell transplant (ASCT) and maintenance treatment postASCT. The Phase III CASSIOPEIA trial offered a glimpse of a much deeper remission with improved PFS in 2021. The PERSEUS trial evaluated the use of Daratumumab up front alongside Lenalidomide, Bortezomib and Dexamethasone (DRVd) in transplant-eligible patients with newly diagnosed myeloma compared to standard of care Lenalidomide, Bortezomib and Dexamethasone (RVd). A significant improvement in PFS of 84.3% compared to 67.7% in the control arm was demonstrated. Measurable residual disease (MRD)-negativity was achieved in 75.2% vs 47.5%, The IMROZ trial, which was published in June 2024, compared Isatuximab, Lenalidomide, Bortezomib and Dexamethasone (Isa-RVD) to RVd in transplant-ineligible patients up until the age of 80. PFS at 60 months was 63.2% in the treatment arm vs 45.2% in the control arm, MRD-negativity was 55.5% in the treatment arm vs 40.9% in the control arm. These studies highlight the utility of drugs previously known to be effective in RRMM later demonstrating their benefit earlier in treatment ladder.
Antibody dependent Cellular Cytotoxics (ADCC)
For patients with relapsed/ refractory myeloma, the Phase III
DREAMM-7 Study published in 2024 examined a new monoclonal antibody Belantamab mafodotin, which binds to an antigen heavily expressed on clonal plasma cell called BCMA (B-Cell Maturation Antigen), in combination with Bortezomib and Dexamethasone. The treatment arm was compared to Daratumumab in combination with Bortezomib and Dexamethasone. This trial demonstrated a median PFS improvement of 23 months in the Belantamab arm from 13.4 months to 36.6 months in the treatment arm. Data presented recently at the American Society of Haematology demonstrated overall survival (OS) advantage as well, particularly on first relapse. The DREAMM-8 Study compared Belantamab, Pomalidomide and Dexamethasone (BPd) with Pomalidomide, Bortezomib and Dexamethasone (PVd) for use in relapsed refractory disease after at least one line of therapy including Lenalidomide. This study demonstrated significantly higher proportion of patients in the Belantamab group (40%) achieved a complete response compared to that of the control group (15%). Median PFS had not been reached in the treatment arm after 22 months of follow up compared to the median PFS of the control arm of 12 months. While there are more adverse effects associated with Belantamab, such as ocular toxicities, these typically resolve after holding or dose reducing the drug. This drug could become a vital option in the future as it is suitable for a broad range of individuals of varying frailties and can be given in an outpatient Day Ward setting without the need for admission to hospital. Administration in an outpatient setting not only reduces hospitalrelated costs and vital bed space in chemotherapy wards but also enhances patient convenience and quality of life.
Bispecific Antibody therapy: Bispecific Antibodies (BiAbs), which include Bispecific T-cell engagers (BiTEs), have emerged in the last 5 years as an effective treatment modality in the management of many haematological diseases. They function by facilitating T-cell mediated cell death by essentially
guiding T-cells to specific antigens on cancer cells. After excellent results demonstrated in the treatment of acute lymphoblastic leukaemia with Blinatumomab in the last decade, bispecific drugs have been used across a multitude of haematological malignancies due to their selective mechanisms of action and balanced off-target toxicities.
Bispecific drugs are licensed by the FDA in the treatment of patients with relapsed refractory myeloma who have failed three or more prior lines of therapy which must include an antiCD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory drug. Elranatanab, Teclistamab and Linvoseltamab are bispecific drugs which bind to the domain binding site of BCMA on myeloma cells as well as CD3 on T cells, however, unlike in CAR-T where BCMA is targeted with a once-off treatment these parenteral drugs require continuous treatment for efficacy.
Elranatanab’s efficacy in relapsed refractory myeloma was evaluated in the MagnetisMM trials. The MagnetisMM-3 trial followed patients for 24 months and demonstrated a PFS of 17.2 months in patients who were treated with Elranatanab and had been treated with three or more lines of therapy prior. 37.4% of patients had achieved a complete response or better with 67% of those maintaining their response by 24 months. Teclistamab has been investigated in the MajesTEC study and has been FDA-approved since October 2022. The MajesTEC-1 trial demonstrated a PFS of 11.3 months on follow-up of patients for 14 months, with 39.4% of patients achieving a complete response or better. The results of the LINKER-MM trial were published in June 2024 which investigated the efficacy and safety profile of Linvoseltamab. Patients were followed for 14 months with 50% achieving a complete response or better. The median PFS was not reached, but the probability of remaining in PFS at 12 months was 70%. Linvoseltamab is administered intravenously weekly with each administration requiring admission for 24 hours to observe for CRS and ICANS with a step-up
Prof. John Quinn
Saad Sharif
Generic Product Launch
Perindopril arginine/ Indapamide/Amlodipine Teva
Film-coated Tablets
perindopril arginine/ indapamide/amlodipine
Indications
Perindopril arginine/Indapamide/Amlodipine Teva:
As substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level.
Presentation: Each film-coated tablet contains 5mg or 10mg perindopril arginine, 1.25mg or 2.5mg indapamide and 5mg or 10mg of amlodipine. Indications: As substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level. Dosage and administration: For oral use. Adults: One Perindopril/Indapamide/Amlodipine film-coated tablet per day as a single dose. Children: Not recommended for use in children and adolescents. Elderly: Elimination of is decreased in the elderly. Treatment should be initiated after considering blood pressure response and renal function. Renal impairment: Contraindicated in patients with severe renal impairment (creatinine clearance below 30mL/min). In patients with moderate renal impairment (creatinine clearance 30-60mL/min), treatment at doses of 10mg/2.5mg/5mg and 10mg/2.5mg/10mg is contraindicated. In patients with creatinine clearance greater than or equal to 60ml/min, no dose modification is required. Hepatic impairment: Contraindicated in patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, Perindopril/ Indapamide/Amlodipine should be administrated with caution, as dosage recommendations for amlodipine in these patients have not been established. Contraindications: Hypersensitivity to the active substances, to other sulphonamides, to dihydropyridine derivatives, any other ACE-inhibitor or to any of the excipients. History of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy. Dialysis patients. Patients with untreated decompensated heart failure. Severe renal impairment. Moderate renal impairment for Perindopril/ Indapamide/Amlodipine 10mg/2.5mg/5mg and 10mg/2.5mg/10mg. Hereditary/ idiopathic angioedema. Second and third trimesters of pregnancy. Hepatic encephalopathy. Severe hepatic impairment. Hypokalaemia. Combination with nonantiarrhythmic agents causing Torsades de Pointes. Severe hypotension. Shock, including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (e.g. high-grade aortic stenosis). Haemodynamically unstable heart failure after acute myocardial infarction. Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment. Concomitant use with sacubitril/valsartan therapy. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Precautions and warnings: The combination of lithium and the combination of perindopril/indapamide is usually not recommended. There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). If dual blockade therapy is considered necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. The combination of perindopril and potassium-sparing drugs, potassium supplements or potassium containing salt substitutes is usually not recommended. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. There is an increased risk of hypotension and renal insufficiency when patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors. Treatment with diuretics may be a contributory factor. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, including
Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67E5AO, Ireland.
Freephone: 1800 - 201 700 | Email: info@teva.ie
Prescription Only Medicine.
perindopril. This may occur at any time during treatment. In such cases perindopril should be discontinued promptly. Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution and/or measures to ensure a patent airway, should be administered promptly. There have been isolated reports of patients experiencing sustained, life-threatening anaphylactoid reactions while receiving ACE inhibitors during desensitisation treatment with hymenoptera (bees, wasps) venom. ACE inhibitors should be used with caution in allergic patients treated with desensitisation and avoided in those undergoing venom immunotherapy. Rarely, patients receiving ACE inhibitors during low density lipoprotein (LDL)-apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE-inhibitor therapy prior to each apheresis. Patients with primary hyperaldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the reninangiotensin system. Therefore, the use of this product is not recommended. ACE inhibitors should not be initiated during pregnancy; when pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately. When liver function is impaired, administration of the diuretic should be stopped immediately if this occurs. If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun. Thiazide diuretics and thiaziderelated diuretics may reduce urinary excretion of calcium and cause a mild and transient increase in plasma calcium levels. Thiazides and related diuretics including indapamide have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia. If Perindopril/Indapamide/Amlodipine is prescribed to patients with known or suspected renal artery stenosis, treatment should be started in a hospital setting at a low dose and renal function and potassium levels should be monitored, since some patients have developed a functional renal insufficiency which was reversed when treatment was stopped. A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. If the prescription of an angiotensin converting enzyme inhibitor is still preferred, continuation of treatment may be considered. The risk of hypotension exists in all patients, but particular care should be taken in patients with ischaemic heart disease or cerebral circulatory insufficiency, with treatment being started at a low dose. The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with heart failure should be treated with caution. ACE inhibitors should be used with caution in patients with an obstruction in the outflow tract of the left ventricle. In patients with insulin dependent diabetes mellitus (spontaneous tendency to increased levels of potassium), treatment should be started under medical supervision with a reduced initial dose. As with other angiotensin converting enzyme inhibitors, perindopril is apparently less effective in lowering blood pressure in black patients than in non-black patients, possibly because of a higher prevalence of low-renin states in the black hypertensive population. Angiotensin converting enzyme inhibitors can cause hypotension in cases of anaesthesia, it is therefore recommended that treatment with long-acting angiotensin converting enzyme inhibitors such as perindopril should be discontinued where possible one day before surgery. Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Tendency to gout attacks may be increased in hyperuricaemic patients. Interactions: Concomitant use of ACE inhibitors with sacubitril/valsartan, racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and gliptins
(e.g. linagliptin, saxagliptin, sitagliptin, vildagliptin) may lead to an increased risk for angioedema. Hyperkalaemia may occur in some patients treated with Perindopril/ Indapamide/Amlodipine. Some drugs or therapeutic classes may increase the occurrence of hyperkalaemia: aliskiren, potassium salts, potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride), ACE inhibitors, angiotensin-II receptors antagonists, NSAIDs, heparins, immunosuppressant agents such as ciclosporine or tacrolimus, trimethoprim and cotrimoxazole (trimethoprim/ sulfamethoxazole), as trimethoprim is known to act as a potassium-sparing diuretic like amiloride. The combination of these drugs increases the risk of hyperkalaemia, therefore, the combination of Perindopril/Indapamide/Amlodipine with the abovementioned drugs is not recommended. If concomitant use is indicated, they should be used with caution and with frequent monitoring of serum potassium. Please refer to the SmPC for the full list of known interactions with concomitant products which are either contraindicated, “not recommended”, or “require special care”. Pregnancy and lactation: Not recommended during the first trimester of pregnancy. This medicine is contraindicated during the second and third trimesters of pregnancy. Perindopril/Indapamide/Amlodipine is contraindicated during lactation. A decision should be made whether to discontinue nursing or to discontinue Perindopril/ Indapamide/Amlodipine taking account the importance of this therapy for the patient. Effects on ability to drive and use machines: No studies on the effects of fixed combination of perindopril/indapamide/amlodipine on the ability to drive and use machines have been performed. Perindopril and indapamide have no influence on the ability to drive and use machines but individual reactions related to low blood pressure may occur in some patients. Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients suffer from dizziness, headache, fatigue, weariness or nausea, the ability to react may be impaired.
Adverse reactions: Agranulocytosis, aplastic anaemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia, hypersensitivity, hyperkalaemia, hypokalaemia, syncope, peripheral neuropathy, angina pectoris, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, Torsade de Pointes (potentially fatal), pancreatitis, gastritis, hepatitis, jaundice, pemphigoid, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, rhabdomyolysis, renal failure, electrocardiogram QT prolongation. Common: Dizziness, headache, paraesthesia, dysgeusia, visual impairment, tinnitus, vertigo, hypotension, cough, dyspnoea, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, pruritus, rash, muscle spasms, asthenia. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: There is no information on over-dosage with fixed combination of perindopril/indapamide/amlodipine in humans. For perindopril/indapamide combination the most likely adverse reaction in cases of overdose is hypotension, sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion. For amlodipine, experience with intentional overdose in humans is limited. Gross overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported. Non-cardiogenic pulmonary oedema has rarely been reported that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Please refer to the SmPC for full guidance on management of overdosage. Legal category: POM. Marketing Authorisation Number: PA1986/108/001-004. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands. Job Code: MED-IE-00091. Date of Preparation: January 2025
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie.
Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com
Date of Preparation: January 2025 | Job Code: GEN-IE-00114
Further information is available on request or in the SmPC. Product Information also available on the HPRA website.
Myeloma
regimen lasting three weeks with an acceptable safety profile. The most common adverse events of these BCMA-targeting bispecific drugs were CRS, myelosuppression and ICANS.
Real-world data is still pending to compare the drugs’ safety and efficacy. Teclistamab was only recently licensed in March 2025 in Ireland for RRMM as a fourth or later line of therapy and has been implemented with a stepup regimen requiring at least 6 days as an inpatient to escalate the drug dose to full while Elranatanab and Linvoseltamab are still pending license for use in Ireland in relapsed refractory disease. After dose escalation, Teclistamab can be administered in an outpatient setting with weekly injections that can be switched to biweekly after 6 months, provided treatment efficacy and tolerability have been established. While these drugs are currently licensed or intended for use in relapsed refractory disease with this current regimen, these drugs could potentially be incorporated into earlier lines of MM therapy and dosing frequency may be spaced out earlier in future as was the case with drugs which have been in circulation longer and have had efficacy and safety profile more thoroughly assessed.
Other bispecific drugs include Talquetamab, which targets a domain-binding site other than BCMA. Talquetamab targets GPRC5D x CD3 and has been used both as monotherapy and in combination with other bispecific drugs to induce a more complete and prolonged response despite an increase in adverse effect profile. The MonumenTAL study was a Phase 1b-2 study which assessed Talquetamab in combination with Teclistamab. Although the incidence of Grade 3 and 4 infections as well as mortality was higher in this group, PFS at 12 months was 78% and at 18 months was 70%. These studies suggest that combining different bispecific therapies may offer enhanced efficacy, albeit with a trade-off in safety concerns that will need to be carefully managed. Further trials are in the works to determine if a more favourable safety outcome can be obtained.
CAR-T involves initially harvesting the patient’s T Cells via leukapheresis, a process which separates the white cells from the rest of the blood. These T cells are then genetically modified to express a chimeric antigen receptor which targets the
disease (MRD) negative status. Cilta-cel was evaluated in the CARTITUDE trial, demonstrating median PFS of 34.9 months with 60% of patients achieving MRDnegativity at any point during the trial. It was FDA-approved in February 2022 for use in RRMM after three prior lines of therapy and is currently approved for use in first relapse after treatment with a regimen involving Lenalidomide, however is still awaiting license in Ireland. While CAR-T represents a clinically proven step in the management of relapsed refractory MM, there are risks of toxicity, notably CRS and ICANS. While these can be managed with immunosuppressants, if severe enough they may necessitate transfer to ICU for haemodynamic support. Researchers are currently working on identifying novel antigens that could be used in isolation or in combination with the BCMA.
tumour-associated antigen. Once these CAR-T cells have been enriched and activated, they’re grown until the target amount has been reached and then reinfused back into the bloodstream, binding both the target antigen on the tumour cells as well as recruiting immune cells to attack the malignant cells. Since 2021, CAR-T has been available in Ireland in St James’ Hospital. It is currently offered for the treatment of B Cell Acute Lymphoblastic Lymphoma in patients 25 years of age and younger and of Relapsed refractory DLBCL. CAR-T is approved by the FDA for treatment of early and advanced stages of myeloma and is awaiting licensing for reimbursement in Ireland for use in Myeloma.
The domain in MM targeted by the two currently approved agents, Ciltacabtagene autoleucel (Ciltacel) and Idecabtagene vicleucel (Ide-cel), is BCMA. Studies thus far have been favourable regarding overall response. Idecel was FDA-approved in March 2021 for use in RRMM after three prior lines of therapy, it is more recently approved for RRMM after two prior lines of therapy. The KarMMa trial demonstrated with Ide-cel a median PFS duration of 8.8 months with 26% of patients obtaining measurable residual
Examples of such antigens include CD319 (SLAMF7) which is being investigated with the CARAMBA project. This incorporates a virus-free Sleeping Beauty CAR gene transfer, which enhances the safety profile and reduces the cost of CAR-T cell manufacturing. Given cost is a significant barrier in the licensing of therapeutics in Ireland and around the world, this confers economic viability and sustainability. Another binding site, G protein-coupled receptor family C group 5 member (GPRC5D) is also being investigated as a potential target for CAR-T in the MCARH prospective trial.
Conclusions:
The future of MM treatment is promising, with continued innovation likely to further transform the landscape of care for these patients. Oral therapies are also in development such as Iberdimide, an immunomodulatory drug which adds to the expanding repertoire of RRMM treatments. This drug is currently under investigation in the EXCALIBUR trial in combination with Daratumumab, Bortezomib and Dexamethasone in patients with relapsed refractory disease.
In conclusion, these are exciting times in MM therapeutics. Ongoing trials are undergoing recruitment whilst agents which are FDA-approved are obtaining license for reimbursement in Ireland over time. These clinical trials give hope for a future where patients with MM experience longer overall survival, better quality of life, and fewer treatment and disease-related complications. References available on request
Review of the Irish Melanoma Forum 2024
The 12th Annual Scientific Meeting of the Irish Melanoma Forum (IMF) was held on May 2, 2024, at O'Reilly Hall, University College Dublin (UCD). This significant event brought together experts from research, clinical practice, and patient advocacy to discuss the latest advancements in melanoma research, diagnosis, and treatment. Co-chaired by Professor Shirley Potter and Professor Desmond J. Tobin, the conference highlighted the increasing importance of collaboration in addressing Ireland’s growing melanoma rates.
Multidisciplinary Focus and Leadership
Professor Potter, a Consultant Plastic and Reconstructive Surgeon at St James’s Hospital and Blackrock Clinic, and Clinical Professor at UCD School of Medicine, emphasised the necessity of a multidisciplinary approach in melanoma management. Her clinical expertise spans melanoma, advanced skin cancer, and head and neck microvascular reconstruction.
Professor Tobin, Full Professor of Dermatological Science and Director of The Charles Institute of Dermatology at UCD, brings a robust research background in skin and hair sciences, particularly focusing on pigmentation in health and disease, including melanoma. Their combined leadership reflects a strategic integration of clinical practice and basic laboratory research, aiming to foster comprehensive advancements in melanoma understanding and treatment, as well as melanoma research capacity-building in Ireland.
Key Themes and Discussions
Several key themes shaped the discussions at the forum, focusing on personalised medicine, novel therapeutic approaches, and emerging biomarkers:
- Clinical Research in Phenotypes, Biomarkers, and Histopathology:
Chaired by Prof. Aurelie Fabre and Dr Paula Calvert, this session included a keynote from Prof. Sapna Patel of MD Anderson Cancer Centre, who discussed perioperative systemic therapy in melanoma. Presentations by Mr Tim Arentsen and Ms Katie Hanratty explored gene expression profiling and molecular analysis in both cutaneous and uveal melanoma, emphasising early detection and risk assessment.
- Basic Research: Led by Prof. Breandán Kennedy and Dr
Professor Desmond J. Tobin and Professor Shirley Potter
Cristina Casalou, this session delved into the mechanisms of melanoma progression.
Prof. Colin Goding from the Ludwig Institute for Cancer research at University of Oxford discussed phenotypic plasticity in melanoma and its role in therapy resistance. Researchers such as Ms Marta Valenti and Ms Marzia Pendino presented novel research, including the role of oestrogen stimulation and cannabinoid-based therapies for uveal melanoma.
- Melanoma Management: Chaired by Prof. Derek Power and Prof. Paul Donnellan, this session covered both the psychological and clinical aspects of treatment. Dr Sinéad Lynch highlighted the importance of psycho-oncology in post-cancer care, while Prof. James Larkin from The Royal Marsden NHS Foundation Trust presented on cellular therapy and its potential to reach a clinical inflection point. Dr Garret O’Connell and Dr Chris Cronin addressed surgical excision variations and the development of consensus guidelines for neoadjuvant immunotherapy.
- Sentinel Node Biopsy and Systemic Therapy: Chaired by Dr Aoife Lally and Mr Fiachra Martin, this session featured Prof. Marc Moncrieff, who questioned the relevance of sentinel node biopsy in light of advances in systemic therapy. The session concluded with a Multidisciplinary Team (MDT) discussion, allowing experts to collaborate on complex melanoma cases.
Challenges and Future Directions
As melanoma rates continue to rise in Ireland, experts highlighted several challenges and areas for future improvement:
- Access to Advanced Therapies: Despite advancements in melanoma treatments, Irish patients face delays in accessing immunotherapies and targeted treatments due to regulatory and funding challenges. Forum attendees called for streamlined approval processes and better access to oncology drugs.
- Public Awareness and Prevention: Experts emphasised the importance of public education on sun safety and early melanoma detection, especially given Ireland's high proportion of fairskinned individuals. Raising awareness about the dangers of unprotected UVR exposure remains crucial in reducing the disease burden.
- Research and Biobanking Infrastructure: Prof. Desmond Tobin called for increased investment in melanoma research, particularly in strengthening the country’s biobanking infrastructure. Current bio-banking regulations restrict access to human melanoma tissue samples, hindering translational research.
The IMF 2024 meeting was an invaluable platform for collaboration, where researchers, clinicians, and patient advocates could exchange ideas, share research findings, and work together on challenges. As melanoma cases continue to rise, efforts in research, policy reform, and patient education will be essential in improving patient outcomes and alleviating the disease's impact on Ireland’s healthcare system.
The 2025 Meeting Preview
The next Irish Melanoma Forum is scheduled for May 23, 2025, in Dublin, Ireland. The event will feature prominent keynote speakers, including:
- Professor John Kirkwood (University of Pittsburgh) –A world leader in melanoma research, particularly in melanoma biology and targeted therapies.
- Professor David Fisher (Harvard Medical School) –Known for his ground breaking research on molecular and genetic events that underlie melanoma formation
- Professor John Crown (St. Vincent’s Private Hospital & Dublin City University) –One of the most prominent Irish oncologists, known for his expertise in cancer treatment and his advocacy for personalised medicine approaches in oncology.
- Professor Myles Smith (Royal Marsden Hospital) –Specialising in melanoma surgical oncology, he has contributed significantly to the surgical treatment of melanoma.
In addition to these keynotes, the 2025 meeting will feature parallel sessions such as the Melanoma Clinical Nurse Specialist Parallel Meeting, focusing on patient management, education, and support, and the Cancer Trials Ireland Parallel DSSG Meeting, discussing clinical trials. The Patient Advocate Parallel Meeting will empower advocates with the latest strategies to support melanoma patients and their families.
The 2025 forum promises to build on the successes of 2024 by addressing cutting-edge research and clinical practices in melanoma care and treatment. As the IMF continues to evolve, it serves as a vital platform for healthcare professionals, researchers (incl. early career researchers via travel bursaries etc.) and patient advocates to come together in the fight against melanoma.
For the most up-to-date information on the goals and agenda of the 2025 meeting, it is advised to consult official sources closer to the event date.
Advancing Treatment for Newly Diagnosed Multiple Myeloma: The Isa-RVD Clinical Trial
Written by Prof. Peter O’Gorman, Mater Hospital
“The trial aims to enhance treatment response while maintaining a manageable safety profile. The results of this trial will contribute to our understanding of optimal frontline treatment strategies for multiple myeloma”
Multiple myeloma remains a complex and challenging disease, requiring continuous advancements in treatment to improve patient outcomes. The Isa-RVD (CTRIAL-IE 19-34) clinical trial is led by myself as Consultant Haematologist at the Mater Misericordiae University Hospital and sponsored by Cancer Trials Ireland. The trial is investigating a novel four-drug regimen for patients with newly diagnosed multiple myeloma (NDMM).
This international, phase II, multi-centre trial is evaluating the addition of Isatuximab, a monoclonal antibody targeting CD38, to standard treatment, Lenalidomide, Bortezomib, and Dexamethasone. Our objective is to assess the efficacy and safety of this regimen and determine its potential as a frontline treatment option for NDMM patients. The trial is a collaboration with investigators from the Dana-Farber Cancer Institute in Boston, who are running a complementing sister trial in the United States. Together with the Dana-Farber Cancer Institute, I will collaborate on an
ambitious correlative science program to identify biomarkers for response, resistance and risk.
Trial
Progress and Recruitment
The Isa-RVD trial, opened for recruitment in March 2022 and completed accrual March 2025, recruiting 54 patients, across five Irish sites and one international site in Denmark. The Participating sites include:
• Mater Misericordiae University Hospital/Mater Private Hospital (24 patients)
• University Hospital Limerick (14 patients)
• University Hospital Waterford (7 patients)
• Beaumont Hospital (4 patients)
• St James’s Hospital (2 patients)
• Aarhus University Hospital, Denmark (3 patient)
Trial Objectives and Clinical Significance
The primary endpoint of this trial is to assess the Very Good Partial Response (VGPR) or
better rate after two cycles of induction therapy, as defined by the International Myeloma Working Group (IMWG) criteria.
The trial aims to enhance treatment response while maintaining a manageable safety profile. The results of this trial will contribute to our understanding of optimal frontline treatment strategies for multiple myeloma.
I would like to extend my gratitude to the patients, investigators, and research staff across all participating centres. Their dedication and commitment
are essential in driving forward innovative research that has the potential to improve outcomes for multiple myeloma patients in Ireland and beyond.
As we observe Multiple Myeloma Awareness Month, this trial underscores the importance of clinical trials in shaping the future of myeloma care. I look forward to sharing further insights as the trial progresses.
For more information, please visit Study Details | Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma | ClinicalTrials.gov
Raising Awareness of Arthritis
Written by Maebh Coyle, Arthritis Ireland
Each year, Arthritis Ireland strives to raise awareness of the challenges facing those living with arthritis, in addition to sharing and promoting self-management techniques. The theme of this year’s National Arthritis Week (held during the first week of April) was ‘Empowering Lives with Lifestyle Medicine’. The goal of this week was to highlight the latest evidence-based, best practice guidelines for the management of all forms of arthritis.
The six pillars of lifestyle medicine
Our education campaign highlighted six key pillars of lifestyle medicine which are known to have a big impact in the management of symptoms of arthritis (and possibly also playing a role in preventing it from occurring in the first place).
• Diet and Nutrition: Promoting the importance of a balanced diet, such as the Mediterranean diet, which is high in fibre and helps lower inflammation.
• Exercise and Movement: Encouraging regular exercise like swimming, aqua-aerobics, walking, cycling, Pilates, and yoga to improve joint flexibility and reduce stiffness.
• Sleep and Rest: Emphasising good sleep hygiene practices to manage pain and fatigue.
• Managing Stress: Providing techniques such as mindfulness, meditation, and deep breathing exercises to reduce stress.
• Smoking and Substance Misuse: Educating on the benefits of reducing or eliminating smoking and excessive alcohol consumption.
• Relationships and Connections: Highlighting the importance of supportive relationships and community involvement for emotional well-being.
How we reached our audience
During National Arthritis Week, Arthritis Ireland launched a dynamic campaign featuring graphic resources and content that highlighted the transformative benefits of lifestyle medicine. Through a series of lifestyle medicine webinars, dedicated landing pages and social media posts, the campaign demonstrated how simple changes can lead to significant improvements in symptoms and overall health. In addition to raising awareness, these assets also succeeded in driving more visitors to the Arthritis Ireland website, social channels, self-management programmes, helpline and fundraising activities.
Informative webinars
The webinars were given by a number of health psychologists and lifestyle medicine physicians from RCSCI (including Dr Lisa Mellon, Dr Kate McCann, Dr Alan Maddock and Dr Maria Pertl). Topics covered included an introduction to Lifestyle Medicine, including where to begin and how to incorporate the six pillars into daily life, as well as focus on social connections, sleep, stress reduction and mindfulness.
Motivating patients
It is generally understood that behavioural change is hard, but it is a very worthwhile goal given the convincing evidence that these lifestyle changes are likely to have a significant impact on public health. One key aspect involved in behavioural change (and motivation) is to focus on the sense of wellbeing that lifestyle changes can offer to individuals almost immediately, rather than solely on the longer-term outcomes. These benefits have been shown to foster greater self-esteem, self-efficacy and a sense of empowerment in people living with a chronic condition.
Putting it all together
Individuals are encouraged to reflect on their goals, design an action plan, track progress, and access resources for ongoing support. Goal-setting is vital to help focus efforts and energy towards clear objectives, which can help sustain motivation through the change journey. Some important questions to ask patients when setting goals include;
• How do you want to feel?
• What do you want to focus on?
• Where to you want to go with this?
As an individual progresses, it is helpful to not only focus on the end goal, but also the benefits and changes experienced along the way. To help you discuss these aspects of behaviour change with your patients, please download and disseminate this lifestyle medicine booklet, https://www.arthritisireland. ie/Handlers/Download. ashx?IDMF=ff6482e1-1110-4c0091e6-d1171c47d9ac
Additional resources
The Arthritis Ireland helpline is open Monday to Friday, 10am4pm (0818 252 846) or via email at: helpline@arthritisireland.ie – offering a confidential service that can provide support on a whole range of issues relating to arthritis, from work related concerns to emotional wellbeing or medications advice.
For anyone recently diagnosed with arthritis, please refer them to our Steps Programme. STEPS
is a unique programme that helps people understand their diagnosis, adjust their behaviour and lifestyle, and embrace supported self-management of their disease. It is a unique way to introduce people to the supports and services available from Arthritis Ireland by offering personally-tailored information to support them, no matter where they are on their arthritis journey. Use this referral form to refer your patients to Arthritis Ireland’s STEPS programme: or access it on the Arthritis Ireland website (arthritisireland.ie). Below we outline the process:
Step 1 – Healthcare professional gets consent to pass details to Arthritis Ireland
Step 2 – Within 3-5 working days, a fully trained peer arranges suitable call time with individual
Step 3 – The peer completes a screening form during initial conversation
Step 4 – Based on the screening form, a personalised pack of information is posted
Step 5 – After 8 weeks a follow-up call & screening form is completed
Step 6 – Comparisons are made and data from calls assessed
*Crucially, this service does not interfere with, nor replace, treatment with your rheumatology clinic or by any other medical professional. Rather it emphasises supported self-management –whereby the individual patient is in control of their condition but is supported by Arthritis Ireland throughout their journey.
Diabetes
Understanding Diabetes: Type 1 vs Type 2
Diagnosis and Treatment
Written
by Professor Derek O’Keeffe, Consultant Physician/ Professor of Medical Device Technology, University Hospital Galway, Ireland/Digital Health Principal Investigator, CURAM Research Ireland Centre for Medical Devices, Ireland, National Clinical Lead Diabetes, HSE.
Dr Lyle McVicker, University Hospital Galway, Endocrinology SPR, Research Physician, University Hospital Galway - As endocrinologists, we frequently encounter diagnostic challenges when differentiating between diabetes types. While both Type 1 and Type 2 diabetes share hyperglycaemia as their hallmark, their underlying pathophysiology, management approaches, and progression significantly differ. This article aims to provide hospital practitioners with practical knowledge on diagnosing diabetes, distinguishing between its main types and effectively managing them.
Diagnosing Diabetes
The American Diabetes Association (ADA) and World Health Organization (WHO) have established clear diagnostic criteria for diabetes. A definitive diagnosis requires meeting one of these threshold values:
• Haemoglobin A1C ≥48 mmol/ mol
• Fasting plasma glucose ≥7.0 mmol/L (following at least 8 hours without caloric intake)
• 2-hour plasma glucose ≥11.1 mmol/L during an oral glucose tolerance test (OGTT)
• Random plasma glucose ≥11.1 mmol/L in patients exhibiting classic hyperglycaemic symptoms
Clinicians should consider testing for diabetes when patients present with classic symptoms including polyuria (frequent urination), polydipsia (increased thirst), unexplained weight loss, recurrent infections, delayed wound healing, blurred vision, or fatigue.
For asymptomatic patients, diagnosis should never rely on a single abnormal test result. Confirmation requires a second test, either of the same type or a different one, showing values within the diabetic range. When discordant results occur between tests, repeating the abnormal test is recommended, with careful consideration of factors that might affect glucose or A1C measurements.
Diabetes. But, what type?
The distinction between diabetes types is crucial for implementing appropriate treatment strategies. Type 1 diabetes generally requires insulin replacement
Feature
Type 1
Age of Onset Usually <35 years but can
from diagnosis, while type 2 may initially respond to non-insulin therapies. Figure 1 shows a simple breakdown of the classic clinical features of each type.
Type 2 Diabetes
Typically >40 years but occur at any age increasingly common in younger individuals
Body Mass Index Often normal or underweight
Overweight or obese (BMI) (BMI ≥25 kg/m2)
Symptoms Acute onset, polyuria, polydipsia, Insidious onset, often weight loss, ketosis asymptomatic, may present with complications
Family History Less common, associated with Strong family history autoimmune diseases of diabetes
Not initially required, but may be needed over time
As is true of the old adage, ‘’patients don’t always read the textbooks’’ and as such we are often left scratching our head as to the type of diabetes a patient may have. When clinical features don't clearly point to a specific diabetes type, biomarker testing provides valuable insights:
Islet autoantibody testing is most informative when conducted within three years of diagnosis. Clinicians should test for multiple antibodies including GAD, IA2, and ZnT8, as the presence of multiple positive antibodies strongly supports a type 1 diagnosis. It's important to note that higher false positive rates occur in older adults, which often necessitates confirmation with C-peptide testing for accurate classification.
C-peptide testing becomes particularly useful when evaluating patients with long-duration diabetes. Very low C-peptide levels (<0.24 ng/mL) strongly indicate type 1 diabetes, while intermediate values (0.6–1.8 ng/mL) require
Dr Lyle McVicker
Professor Derek O’Keeffe
Figure 1. Characteristic features of Type 1 and Type 2 Diabetes
Diabetes
careful clinical correlation as they could represent type 1 diabetes, MODY, or insulin-treated type 2 diabetes. Measurements should be paired with a serum glucose level to aid interpretation.
When interpreting biomarker results, clinicians should consider the complete clinical picture. A patient with negative autoantibodies but persistently low C-peptide levels might still have type 1 diabetes, particularly if the testing was performed many years after diagnosis when autoantibodies may have disappeared. Conversely, a patient with weakly positive single autoantibody but robust C-peptide production likely has type 2 diabetes with a false positive antibody result. This integrated approach to biomarker interpretation helps resolve diagnostic dilemmas in clinically ambiguous presentations.
Generally speaking, if in doubt regarding the underlying cause of diabetes it is safest to err on the side of caution and treat in a way that most reduces potential harm i.e. diabetic ketoacidosis (DKA). In practice this means oftentimes starting insulin on a patient newly diagnosed with diabetes where uncertainty exists between a diagnosis of type 1 of type 2. This is sometimes done while awaiting antibody results and continued until a short interval clinic appointment following hospital discharge. If after several weeks, antibodies have returned negative and the clinical picture more resembles one of type 2 diabetes the insulin can be carefully tapered off or stopped outright and oral medications instituted.
Challenging Clinical Presentations of Diabetes
Type 1 diabetes in older adults presents unique diagnostic challenges. Despite classic presentations with DKA, type 2 diabetes remains significantly more common in older age groups. Negative autoantibody testing in older adults makes type 1 diabetes much less likely, and routine autoantibody screening isn't necessary if typical type 1 features are absent. For cases with uncertain classification, C-peptide measurement provides valuable confirmation, helping to distinguish late-onset type 1 from insulin-requiring type 2 diabetes, thus guiding appropriate therapeutic approaches.
Indeed, early insulin requirement serves as an important predictive factor for misdiagnosed type 1 diabetes. Patients initially classified as having type 2 diabetes who
require insulin therapy within three years of diagnosis likely have slowly progressive type 1 diabetes. These patients should undergo comprehensive biomarker testing, including autoantibody and C-peptide assessment, to confirm the correct diagnosis. Early recognition of misclassified type 1 diabetes helps prevent dangerous gaps in insulin therapy and inappropriate treatment with agents that may have limited efficacy.
Pancreatic cancer should be considered in the differential diagnosis of new-onset diabetes, particularly in specific high-risk scenarios. Clinicians should maintain heightened vigilance when diabetes presents in patients over 50 years old without typical metabolic syndrome features, especially when accompanied by unexplained weight loss, abdominal pain, or jaundice. The relationship works both ways - new-onset diabetes can sometimes be the first detectable sign of pancreatic cancer, presenting months before the cancer becomes clinically apparent through other symptoms. Early imaging studies should be considered for patients with suspicious presentations, particularly when multiple risk factors are present.
Maturity-Onset Diabetes of the Young (MODY) represents several monogenic forms of diabetes that should be considered when patients present with atypical features. These typically include relatively mild hyperglycaemia (A1C <58 mmol/mol at diagnosis), strong multigenerational family history of diabetes, absence of typical autoimmune or insulin resistance markers, and onset at a young age (typically before 25-30 years). Patients with MODY may also display distinctive clinical features suggesting specific genetic variants, such as renal cysts, lipodystrophy, or characteristic patterns of glycemic control such as persistently elevated fasting glucose with normal post-prandial values. Genetic testing provides definitive diagnosis and guides targeted treatment approaches for these patients. Awareness is critical as a MODY diagnosis can dramatically change treatment regimens and reduce burden on patients.
Latent Autoimmune Diabetes in Adults (LADA) presents a particular diagnostic challenge as it initially resembles type 2 diabetes but has an autoimmune pathophysiology similar to type 1. These patients typically appear to have type 2 diabetes but experience a more rapid progression to insulin
dependence. GAD autoantibody testing aids identification, and early recognition allows for appropriate treatment planning that accounts for the progressive β -cell failure these patients will experience. Recognizing LADA helps clinicians anticipate the eventual need for insulin therapy rather than persisting with combination oral agents that may prove insufficient.
Modern Diabetes Management:
A Practical Guide for Hospital Clinicians
Effective diabetes management requires personalization based on the patient's age, comorbidities, preferences, and social circumstances. While HbA1c targets of ≤53 mmol/mol suit most adults, consider lower targets for selected patients who can achieve them safely, and more relaxed goals (58-69 mmol/mol) for frail elderly patients.
Type 2 Diabetes Management
Most recent international joint consensus guidelines from the ADA and European Association for the Study of Diabetes (EASD) now emphasise the consideration of cardiorenal protection and weight management alongside glycemic control when devising a medication regimen in type 2 Diabetes.
• Metformin: Remains the first-line pharmacological therapy for most patients with type 2 Diabetes due to its proven efficacy, safety profile, low cost, and extensive clinical experience. Metformin has demonstrated modest cardiovascular benefits, is weight neutral or may promote slight weight loss, and has a low risk of hypoglycaemia. Contraindications include severe renal impairment (eGFR <30 mL/min/1.73m2), and dose adjustment is recommended for moderate renal impairment.
• SGLT2 inhibitors: Consider for patients with established cardiovascular disease (CVD), heart failure, or chronic kidney disease regardless of HbA1c. These reduce heart failure hospitalizations and slow CKD progression, particularly in patients with albuminuria.
• GLP-1 receptor agonists: Offer significant cardiovascular benefits for patients with atherosclerotic disease while providing excellent glycemic control and weight reduction. Tirzepatide (dual GIP/GLP-1 agonist) shows superior efficacy for both glucose management and weight loss compared to earlier GLP-1 RAs. It is now
available in Ireland though it's not yet covered by the long-term illness scheme.
• DPP-4 inhibitors: Provide modest glycemic improvements with minimal hypoglycaemia risk and weight neutrality, making them suitable for elderly patients.
• Traditional agents: Sulfonylureas and insulin remain effective for glucose control but carry increased hypoglycaemia risk and weight gain concerns.
Weight management is crucial—5-10% weight loss improves multiple metabolic parameters, while ≥15% loss can induce diabetes remission in some patients. The availability of GLP-1 RAs have revolutionized pharmacological weight management though recent supply shortages have truncated some patients' courses and stopped others from accessing the most potent agents. For patients with BMI ≥35 kg/m2 and suboptimal control despite medication, metabolic surgery should be considered though access to this via both the public and private system in Ireland remains difficult and waiting lists are long.
Despite pharmaceutical advances, lifestyle modifications remain fundamental. Recommend individualized nutrition therapy (Mediterranean, plant-based, or moderate low-carbohydrate approaches) and physical activity (≥150 minutes weekly of moderateintensity activity, resistance training, and reduced sedentary time).
Type 1 Diabetes Management
Person-centred care is essential for type 1 diabetes. Diabetes self-management education and support (DSMES) remains the cornerstone intervention at diagnosis and throughout the patient's life. The DAFNE (Dose Adjustment For Normal Eating) programme, ideally implemented within 6-12 months of diagnosis, equips patients with carbohydrate counting skills and insulin adjustment strategies.
Continuous glucose monitors (CGMs) represent the preferred monitoring approach, focusing on Time in Range (TIR).
Recommend patients aim for >70% of time within 3.9–10.0 mmol/L, while minimizing time below 3.9 mmol/L (<4%, ideally <1% below 3.0 mmol/L).
Insulin therapy options include:
• Multiple daily injections (MDI) with basal-bolus regimens (standard approach)
• Hybrid closed-loop systems (insulin pumps linked to CGM with a software algorithm controlling insulin delivery), which improve outcomes and reduce hypoglycaemia
• Connected insulin pens as intermediate technology, providing dose tracking and decision support
Comprehensive Care Considerations for All Diabetes Types
Beyond glycemic control, address cardiovascular and kidney risk:
• Lipid management: statin therapy for patients >40 years or with additional CVD risk factors. Risk level can be assessed
through use of the American College of Cardiology ASCVD risk calculator (Risk Estimator Plus).
• Annual kidney function screening: albuminuria and eGFR
• Regular retinal screening: The National Diabetic Retinal Screening Programme in Ireland facilitates free screening and onward referral to ophthalmology if required.
• Comprehensive foot care: Annual foot examinations to assess skin integrity, vascular status, and neuropathy using monofilament testing and vibration sensation.
The psychological burden of diabetes requires regular screening for diabetes distress, depression, anxiety, and eating disorders. Pay particular attention during care transitions to prevent treatment gaps. Optimal diabetes management requires a multidisciplinary team including
endocrinologists, diabetes specialist nurses, dietitians, and psychologists to address the complex biological, technological, and psychosocial aspects of diabetes care.
Key Takeaways for HospitalBased Clinicians
1. Individualise treatment plans considering the whole person, not just their HbA1c
2. For type 2 diabetes, select medications based on cardiorenal benefits and weight impacts
3. For type 1 diabetes, prioritise education, CGM, and appropriate insulin delivery methods
4. Address cardiovascular and kidney risk factors in all patients
5. Screen regularly for psychological complications
6. Collaborate with a multidisciplinary team for comprehensive care
Guidance taken from:
1. Department of Health (2024), V2. NCEC National Clinical Guideline No. 17 Adult type 1 diabetes mellitus. Available at: http://health.gov.ie/nationalpatient-safety-office/ncec/
2. Management of Hyperglycaemia in type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 1 November 2022; 45 (11): 2753–2786. https://doi. org/10.2337/dci22-0034
3. The Management of type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 1 November 2021; 44 (11): 2589–2625. https://doi.org/10.2337/ dci21-0043
New Appointment in Respiratory Care News
Roscommon University Hospital (RUH) is delighted to announce the recent appointment of Sarah Daly to the role of Advanced Nurse Practitioner (ANP) in Respiratory Care.
Sarah is ultimately responsible for the assessment, diagnosis and treatment of respiratory conditions, including Asthma, COPD, Lung Fibrosis, Pulmonary Hypertension and Sleep Related Breathing Disorders. Working with respiratory specialists in the Sleep and Respiratory Clinics at University Hospital Galway and Roscommon University Hospital has provided Sarah with additional expertise, allowing her to expand her scope of practice in the field of respiratory care.
A native of Kilconnell in County Galway, Sarah began her nursing career as an enhanced staff nurse in Portiuncula University Hospital. It was there her interest in respiratory care peaked while working with respiratory patients on the medical ward.
She joined Roscommon University Hospital as a candidate Advanced Nurse Practitioner in Respiratory Care in 2022, after obtaining a Higher Diploma in Respiratory Care and a Masters Degree in
Roscommon University Hospital welcomes the recent appointment of Advanced Nurse Practitioner in Respiratory Care Sarah Daly
Nursing. During her two-year candidature, Sarah enhanced her nursing skills further working between Roscommon and Portiuncula University Hospitals, earning a certificate in nurse medicinal prescribing and referring for radiological procedures, before completing a Postgraduate Diploma in Advanced Nursing Practice at the University of Galway.
“Ultimately, my vision for the service in RUH, is to provide respiratory care to patients as close to their homes as possible. As an ANP I can practice independently and autonomously to diagnose, treat, support and educate patients on their respiratory conditions in their local hospital. It's wonderful to see that the service is already making a significant difference in the lives of our patients”, explains Sarah.
Last November Sarah was honoured to receive the Bernie
Carpenter Perpetual Bursary Award from the Irish Association of Advanced Nurse Midwife Practitioners (IAANMP). The bursary will allow Sarah to undertake further studies in the field of respiratory. In May Sarah will travel to Edinburgh to complete a sleep medicine and cognitive behavioural therapy course which will expand her knowledge of sleep related breathing disorders and enhance her skills in supporting patients
diagnosed with obstructive sleep apnoea and other sleep-related breathing disorders.
“I was delighted to receive the bursary award which will enable me to expand the sleep diagnostics service for RUH, provide comprehensive care to patients who have sleep-related respiratory disorders and ensure that patients are examined, diagnosed and treated in a timely manner, as close to home as possible,” added Sarah.
Parkinson’s Disease
What is Parkinson’s Disease: Treatment Options
and Patient Perspective
What is Parkinson’s Disease?
Parkinson’s Disease is the fastest growing neurological condition, and it is estimated that up to 18,000 people are living with the condition in Ireland. This number is expected to double by 2050, which means demand for Parkinson’s services will significantly increase over the coming years.
Parkinson’s Disease (PD) is a progressive neurological disorder, and is classified as a Movement Disorder, as it primarily affects movement. Although Parkinson’s is a movement disorder, there are both motor and non-motor symptoms associated with it. It is variable in its progression, i.e. some people progress more slowly than others, and the symptoms can be effectively controlled with medication for many years. A common misconception surrounding Parkinson’s is that is a condition diagnosed only in the older person, while the average age of diagnosis is over 65 there are increasing numbers of people being diagnosed with early or young onset, under the age of 60, and there is no age too young to be diagnosed with PD.
Parkinson’s Disease is caused by a loss of a chemical called dopamine. We all lose some of this chemical as we get older, however, people with Parkinson’s lose this chemical at a faster rate than others. It is only when 7080% of dopamine has been lost do symptoms tend to be revealed. The concept of prodromal phase in Parkinson’s is evident in many
Written by Lisa Wynne, Parkinson’s Nurse Specialist, Parkinson’s Ireland
research papers, this phase is prior to motor symptoms being displayed and may be the existence of non-motor symptoms for between 5 –15 years before a diagnosis occurs. In existence on their own, these symptoms do not lead to a diagnosis of PD but when taken alongside other symptoms, a picture of PD may gradually be pieced together.
A tremor is a widely recognised motor symptom of Parkinson’s, 70% of people have a tremor, so it is not experienced by all. Tremor, bradykinesia (a slowness in movement), rigidity and a change in posture are the cardinal symptoms of PD but we must also be aware that Parkinson’s is a multifaceted condition and those living with PD may experience 40+ symptoms.
The non-motor symptoms are often unknown, underdiagnosed, and hidden, but for some, they prove to be the more troublesome symptoms to manage. Constipation, bladder issues and sleep issues are just some of the more common examples. The psychiatric symptoms including anxiety, apathy and depression are the more dominant symptoms affecting both people with PD and their families. With little awareness, these often have the biggest impact.
Treatments
There is currently no cure for Parkinson’s. There have however been significant improvements in the treatment of the symptoms of Parkinson’s in the last 20 years. Treatments include drug therapies, surgery, exercise component, and an interdisciplinary team input.
There is extensive research currently being carried out into the causes of Parkinson’s and into developing new treatments for Parkinson’s. The goal of this research is to develop biomarkers to assist in the diagnosis of Parkinson’s, slow down progression or even cure Parkinson’s altogether. As research advances, there are
likely to be better treatments available over time which will improve the quality of life of people with Parkinson’s. The research surrounding Parkinson’s is moving at an expediential pace globally and within Ireland on many different areas, such as treatments, role of our gut, use of pesticides in farming communities and exercise, certainly a growth in the last decade.
Each person with Parkinson’s Disease should have an individualised tailored regime depending upon his/her age, physical state, level of disease etc, thus no two patients’ regimes will be the same. A tailored and personalised approach to all therapies, be they pharmacological or non-pharmacological, should be the foundation of care for a person living with PD.
The management of Parkinson’s Disease is very much a multidisciplinary team approach. Consultants, nurse specialists, physiotherapists, occupational therapists, speech and language therapists, social workers, pharmacists, and many other health care workers play a key role in the overall management of the patient’s condition.
There is a misconception out there that the medications only last for 5 or 6 years or so. This is not necessarily true, as medications continue to work for
as long as they are taken. Due to the progressive nature of the condition medications may need to be reviewed will have to be increased or decreased every so often depending upon the level of progression. Levodopa remains the ‘gold standard’ treatment for the majority, initial use of which was in the 1960’s, with a variation of regimes that can be prescribed concomitantly.
Parkinson’s can be effectively managed with oral medications for a significant amount of time but in some people, the medication no longer controls these symptoms, and they may experience motor fluctuations. As the disease progresses, the tailoring of medication regimes and optimisation of these regimes can become a little more difficult with a narrowing therapeutic window and increased wearing off of medication causing more ‘off’ periods and an increase of symptoms, directly impacting mobility, additional symptoms and quality of life of the person with PD.
Complex therapies may be the next line of treatment considered in this case. Complex therapies include surgical and device treatments. Recent advancements in Parkinson’s treatment from an Irish perspective include the availability of Deep Brain
Stimulation service in Ireland and additional pump therapies. The National DBS (deep brain stimulation) service was established in 2021, providing the neurosurgical aspect in Beaumont Hospital and the neurology management in the Mater Hospital Dublin. In July 2024, the license was approved for levodopa in liquid formulation, delivered via a pump system, providing an additional treatment option for management of advanced Parkinson’s. These recent developments are welcomed following a hiatus in new treatment options for those with PD. Parkinson’s medication is time critical. The delay of medication or a missed dose can result in immediate deterioration of symptoms. Consistency in dosing helps maintain optimal symptom control and reduces the risk of complications like falls and hospitalisations. Missed doses can increase hospital stays, heighten the risk of other health complications, and delay discharge, complicating overall care and treatment plans. Timing and types of medication can vary with each person with Parkinson's.
• Speak with family members to get an accurate medication history.
• Coordinate with the care team to ensure medications are given on time, especially across shifts.
• Utilise tools like reminders and educate patients and caregivers on the importance of strict adherence to dosing schedules.
• Consider use of stickers or visual prompts at bedside, patient chart, electronic records.
Some specific considerations to bear in mind are if the patient is NPO or has an impaired swallow or in the case of peri-operative stages.
Timely medication = Better outcomes. Ensure timely Parkinson's care for improved patient quality of life and reduced hospital stay.
Parkinson’s Ireland will be launching a clinical awareness campaign ‘Meds On Time, Every Time’ later in the year to highlight the importance and increase awareness among many areas. Engagement from clinical staff, people with PD and families will be pivotal in the success of the campaign.
In 2024, Parkinson’s Ireland and Irish Medication Safety Network (IMSN) collaborated on two safety alerts for PD. Alert one focused on ‘Reducing harm from omitted and delayed Parkinson’s Disease Medications in Irish hospitals’ while alert 2 focused on ‘Contraindicated Medication in Parkinson's Disease’. For further information please see www. parkinsons.ie and IMSN website for the most recent publications.
Patient Perspective
Organisations such as Parkinson’s Ireland offer support to those living with Parkinson’s and their families. The core of the work provided by Parkinson’s Ireland is to increase awareness of this condition to all, to provide education and support to optimise therapies and to encourage self-advocacy and empowerment to those living with PD and family members. Selfmanagement for those living with a chronic condition is vital to allow the person to live well and maintain health life and health brain.
Celebrating the Inaugural Flagship Fundraiser with our Donegal Branch
Parkinson’s Ireland is a branchbased charity, with 21 branches across Ireland. Each branch offers a range of services and supports to their members, such as exercise classes, information meetings and social elements such as coffee mornings, Christmas lunches and summer outings. Alongside the in-person branch activities, Parkinson’s Ireland provides a nurse call back and a dietician call back service. Our nurse callback service is available 9am to 5pm, Monday to Friday, and although our helpline is not an emergency one, our nurse specialists always aim to get back to you within one working day. Our helpline manager can also signpost you to other support services available, depending on your situation and needs.
Working with multiple different therapists, we offer virtual classes Monday to Friday on various aspects such as yoga, mindfulness, singing and psychological wellness. Parkinson’s Ireland currently has three PD nurse specialists, providing in person appointment for our Cork members and national phone support line for education and support. This is a valuable and critical lifeline for those either newly diagnosed or living with Parkinson's for a much greater period. A nurse led zoom is facilitated weekly and our nurses also provide a virtual four week newly diagnosed programme with the aim of empowering those with PD and giving them the essential nuggets of information necessary in the earlier days of diagnosis. Throughout the year we provide webinars on topics such as women with PD, carers, and assistive technology, bringing awareness to all, in all corners of the country and
further afield, dispel the myths and associated stigma experienced and provide a network of support in many avenues.
“Since I was diagnosed with Parkinson’s in July 2023, Parkinson’s Ireland has given me enormous help in managing my symptoms.” – Brenda O’Connell, person with PD.
Bringing it all together for awareness month in April, the events will kick off with our flagship fundraiser ‘A Walk in the Park for Parkinson’s’ on April 5th. Taking place in 14 locations nationwide, following a hugely successful launch in 2024 it is hoped this year will surpass our expectations. Our awareness campaign for 2024 was titled ‘Different for Everyone’ to highlight the 40+ symptoms associated with the condition. This year, we wanted there to be a focus on personal stories to help spread further awareness on how Parkinson’s manifests itself differently person to person. During April, Parkinson’s Ireland will share videos from patients, loved ones and health professionals, each person describing one of the many symptoms of Parkinson’s Disease and how Parkinson’s Ireland helps them manage it. “Time to Talk About Parkinson’s” is the title of this year’s annual online conference, where we will have a range of speakers such as dieticians, neurologists and physiotherapists joining us to share advice on how to live positively with PD. Visit www.parkinsons.ie to join our conference on April 12th. If you are unable to join us on the day, a recording will be available from our website soon after.
Please keep an eye on Parkinson’s Ireland’s website and social media during April to find out more about our awareness campaigns, education conference and help us celebrate Parkinson’s Awareness month and World Parkinson's Day on April 11th.
Patients at risk of anaphylaxis should carry 2 Adrenaline auto-injectors1
Patients at risk of anaphylaxis should carry 2 Adrenaline auto-injectors1
ABBREVIATED PRESCRIBING INFORMATION
ABBREVIATED PRESCRIBING INFORMATION
EpiPen (adrenaline) 300 micrograms solution for injection in pre-filled pen, EpiPen Junior (adrenaline) 150 micrograms solution for injection in pre-filled pen
EpiPen (adrenaline) 300 micrograms solution for injection in pre-filled pen, EpiPen Junior (adrenaline) 150 micrograms solution for injection in pre-filled pen
Please refer to Summary of Product Characteristics (SmPC) before prescribing
Please refer to Summary of Product Characteristics (SmPC) before prescribing
Indications, Dosage and Administration: the emergency treatment of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens, as well as idiopathic or exercise induced anaphylaxis.
Indications, Dosage and Administration: the emergency treatment of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens, as well as idiopathic or exercise induced anaphylaxis.
Posology: Paediatric population: Usual paediatric dose is 0.01 mg/kg body weight. However, the prescribing physician has the option of prescribing more or less than these amounts based on careful assessment of each individual patient and recognizing the life threatening nature of reactions for which this is being described. A dosage below 150 micrograms cannot be administered with EpiPen adrenaline Auto-Injector. The physician should consider using other forms of injectable adrenaline if lower doses are felt to be necessary for small children. Children and adolescents over 30 kg in weight: The usual dose is 300 micrograms for intramuscular use. Children between 15 kg and 30 kg in weight: The usual dose is 150 micrograms for intramuscular use. Children below 15 kg in weight: The suitability of EpiPen Junior has to be judged individually. The use in children weighing less than 7.5 kg is not recommended unless in a life-threatening situation and under medical advice. Adults: The usual dose is 300 micrograms for intramuscular use. An initial dose should be administered as soon as symptoms of anaphylaxis are recognized. In the absence of clinical improvement or if deterioration occurs, a second injection with an additional EpiPen or EpiPen Junior Auto-Injector may be administered 515 minutes after the first injection. It is recommended that patients are prescribed two EpiPen or EpiPen Junior pens which they should carry at all times. The physician prescribing an EpiPen or EpiPen Junior Auto-Injector must ensure that the patient understands the indications for use and the correct method of application. Therefore, the physician should discuss the patient information leaflet, the correct handling of the Auto-Injector and the possible symptoms of an anaphylactic shock in detail with the patient. Method of administration: EpiPen Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. For intramuscular administration into the anterolateral thigh, not the buttock. It is designed to inject through clothing or directly through the skin. The patient/carer should be informed that following each use of EpiPen or EpiPen Junior • They should call for immediate medical assistance, ask for an ambulance and state “anaphylaxis” even if symptoms appear to be improving. • Conscious patients should preferably lie flat with feet elevated but sit up if they have breathing difficulties. Unconscious patients should be placed on their side in the recovery position. • The patient should if possible remain with another person until medical assistance arrives.
Posology: Paediatric population: Usual paediatric dose is 0.01 mg/kg body weight. However, the prescribing physician has the option of prescribing more or less than these amounts based on careful assessment of each individual patient and recognizing the life threatening nature of reactions for which this is being described. A dosage below 150 micrograms cannot be administered with EpiPen adrenaline Auto-Injector. The physician should consider using other forms of injectable adrenaline if lower doses are felt to be necessary for small children. Children and adolescents over 30 kg in weight: The usual dose is 300 micrograms for intramuscular use. Children between 15 kg and 30 kg in weight: The usual dose is 150 micrograms for intramuscular use. Children below 15 kg in weight: The suitability of EpiPen Junior has to be judged individually. The use in children weighing less than 7.5 kg is not recommended unless in a life-threatening situation and under medical advice. Adults: The usual dose is 300 micrograms for intramuscular use. An initial dose should be administered as soon as symptoms of anaphylaxis are recognized. In the absence of clinical improvement or if deterioration occurs, a second injection with an additional EpiPen or EpiPen Junior Auto-Injector may be administered 515 minutes after the first injection. It is recommended that patients are prescribed two EpiPen or EpiPen Junior pens which they should carry at all times. The physician prescribing an EpiPen or EpiPen Junior Auto-Injector must ensure that the patient understands the indications for use and the correct method of application. Therefore, the physician should discuss the patient information leaflet, the correct handling of the Auto-Injector and the possible symptoms of an anaphylactic shock in detail with the patient. Method of administration: EpiPen Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. For intramuscular administration into the anterolateral thigh, not the buttock. It is designed to inject through clothing or directly through the skin. The patient/carer should be informed that following each use of EpiPen or EpiPen Junior • They should call for immediate medical assistance, ask for an ambulance and state “anaphylaxis” even if symptoms appear to be improving. • Conscious patients should preferably lie flat with feet elevated but sit up if they have breathing difficulties. Unconscious patients should be placed on their side in the recovery position. • The patient should if possible remain with another person until medical assistance arrives.
Presentation: Solution for injection in pre-filled pen (Auto-Injector). Clear and colourless solution. EpiPen: A single dose (0.3 ml) contains 300 micrograms (0.3 mg) adrenaline (epinephrine). EpiPen Junior: A single dose (0.3 ml) contains 150 microgram (0.15 mg) adrenaline (epinephrine). Contraindications: There are no known absolute contraindications to the use of EpiPen or EpiPen Junior during an allergic emergency. Warnings and precautions: All patients who are prescribed EpiPen or EpiPen Junior should be thoroughly instructed to understand the indications for the use and the correct method of administration. It is strongly advised also to educate the patient’s immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the EpiPen or EpiPen Junior in case support is needed in the emergency situation. The patient should be instructed to dial 112, ask for ambulance, state anaphylaxis to seek emergency medical assistance immediately after administering the first dose in order to have close monitoring of the anaphylactic episode and further treatment as required. The Auto-Injectors should be injected into the anterolateral aspect of the thigh. Patients should be advised not to inject into the buttock. In case of injection performed by a caregiver, immobilization of the patient’s leg should be ensured during injection to minimize the risk of leg laceration, bentneedle or other injuries. The product is for single use only and in no case the used pen should be reused. Adrenaline is ordinarily administered with extreme caution to patients who have a heart disease. Adrenaline should only be prescribed to those patients, but also those suffering from diabetes, hyperthyroidism, hypertension and elderly individuals if the potential benefit justifies the potential risk. There is a risk of adverse reactions following epinephrine administration in patients with high intraocular pressure, severe renal impairment, prostatic adenoma leading to residual urine, hypercalcaemia and hypokalaemia. In patients with Parkinson's disease, epinephrine may be associated with a transient worsening of Parkinson symptoms such as rigidity and tremor. The patient/carer should be informed about the possibility
Presentation: Solution for injection in pre-filled pen (Auto-Injector). Clear and colourless solution. EpiPen: A single dose (0.3 ml) contains 300 micrograms (0.3 mg) adrenaline (epinephrine). EpiPen Junior: A single dose (0.3 ml) contains 150 microgram (0.15 mg) adrenaline (epinephrine). Contraindications: There are no known absolute contraindications to the use of EpiPen or EpiPen Junior during an allergic emergency. Warnings and precautions: All patients who are prescribed EpiPen or EpiPen Junior should be thoroughly instructed to understand the indications for the use and the correct method of administration. It is strongly advised also to educate the patient’s immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the EpiPen or EpiPen Junior in case support is needed in the emergency situation. The patient should be instructed to dial 112, ask for ambulance, state anaphylaxis to seek emergency medical assistance immediately after administering the first dose in order to have close monitoring of the anaphylactic episode and further treatment as required. The Auto-Injectors should be injected into the anterolateral aspect of the thigh. Patients should be advised not to inject into the buttock. In case of injection performed by a caregiver, immobilization of the patient’s leg should be ensured during injection to minimize the risk of leg laceration, bentneedle or other injuries. The product is for single use only and in no case the used pen should be reused. Adrenaline is ordinarily administered with extreme caution to patients who have a heart disease. Adrenaline should only be prescribed to those patients, but also those suffering from diabetes, hyperthyroidism, hypertension and elderly individuals if the potential benefit justifies the potential risk. There is a risk of adverse reactions following epinephrine administration in patients with high intraocular pressure, severe renal impairment, prostatic adenoma leading to residual urine, hypercalcaemia and hypokalaemia. In patients with Parkinson's disease, epinephrine may be associated with a transient worsening of Parkinson symptoms such as rigidity and tremor. The patient/carer should be informed about the possibility
of biphasic anaphylaxis which is characterised by initial resolution followed by recurrence of symptoms some hours later. Patients with concomitant asthma may be at increased risk of a severe anaphylactic reaction. Accidental injection into hands or feet resulting in peripheral ischaemia has been reported. Patients may need treatment following the accidental injection. In patients with thick sub-cutaneous fat layer, there is a risk for adrenaline not reaching the muscle tissue resulting in a suboptimal effect. A second injection with an additional EpiPen may be needed. EpiPen and EpiPen Junior contain sodium metabisulfite which may rarely cause severe hypersensitivity reactions including anaphylactic symptoms and bronchospasm in susceptible people, especially those with a history of asthma. Patients with these conditions must be carefully instructed in regard to the circumstances under which EpiPen or EpiPen Junior should be used. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium -free'. Patients should be warned regarding related allergens and should be investigated whenever possible so that their specific allergens can be characterised. Interactions with other medicinal products and other forms of interaction: Caution is indicated in patients receiving drugs that may sensitise the heart to arrhythmias, including digitalis and quinidine. The effects of adrenaline may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors (MAO-inhibitors) and catechol -O-methyl transferase inhibitors (COMT inhibitors), thyroid hormones, theophylline, oxytocin, parasympatholytics, certain antihistamines (diphenhydramine, chlorpheniramine), levodopa and alcohol. Adrenaline inhibits the secretion of insulin, thus increasing the blood glucose level. It may be necessary for diabetic patients receiving adrenaline to increase their dosage of insulin or oral hypoglycaemic drugs. Observe: The ß-stimulating effect can be inhibited by simultaneous treatment with ß -blocking drugs. Fertility, pregnancy and lactation: Pregnancy: Clinical experience in the treatment of pregnancy is limited. Adrenaline should be used during pregnancy only if the potential benefit justifies the potential risk for the foetus. Breast-feeding: Adrenaline is not orally bioavailable; any adrenaline excreted in breast milk would not be expected to have any effect on the nursing infant. Fertility: As adrenaline is a substance that naturally occurs in the body, it is unlikely that this drug would have any detrimental effects on fertility. Undesirable effects: Side effects associated with adrenaline's alpha and beta receptor activity may include symptoms such as tachycardia and hypertension as well as undesirable effects on the central nervous system.
of biphasic anaphylaxis which is characterised by initial resolution followed by recurrence of symptoms some hours later. Patients with concomitant asthma may be at increased risk of a severe anaphylactic reaction. Accidental injection into hands or feet resulting in peripheral ischaemia has been reported. Patients may need treatment following the accidental injection. In patients with thick sub-cutaneous fat layer, there is a risk for adrenaline not reaching the muscle tissue resulting in a suboptimal effect. A second injection with an additional EpiPen may be needed. EpiPen and EpiPen Junior contain sodium metabisulfite which may rarely cause severe hypersensitivity reactions including anaphylactic symptoms and bronchospasm in susceptible people, especially those with a history of asthma. Patients with these conditions must be carefully instructed in regard to the circumstances under which EpiPen or EpiPen Junior should be used. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium -free'. Patients should be warned regarding related allergens and should be investigated whenever possible so that their specific allergens can be characterised. Interactions with other medicinal products and other forms of interaction: Caution is indicated in patients receiving drugs that may sensitise the heart to arrhythmias, including digitalis and quinidine. The effects of adrenaline may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors (MAO-inhibitors) and catechol -O-methyl transferase inhibitors (COMT inhibitors), thyroid hormones, theophylline, oxytocin, parasympatholytics, certain antihistamines (diphenhydramine, chlorpheniramine), levodopa and alcohol. Adrenaline inhibits the secretion of insulin, thus increasing the blood glucose level. It may be necessary for diabetic patients receiving adrenaline to increase their dosage of insulin or oral hypoglycaemic drugs. Observe: The ß-stimulating effect can be inhibited by simultaneous treatment with ß -blocking drugs. Fertility, pregnancy and lactation: Pregnancy: Clinical experience in the treatment of pregnancy is limited. Adrenaline should be used during pregnancy only if the potential benefit justifies the potential risk for the foetus. Breast-feeding: Adrenaline is not orally bioavailable; any adrenaline excreted in breast milk would not be expected to have any effect on the nursing infant. Fertility: As adrenaline is a substance that naturally occurs in the body, it is unlikely that this drug would have any detrimental effects on fertility. Undesirable effects: Side effects associated with adrenaline's alpha and beta receptor activity may include symptoms such as tachycardia and hypertension as well as undesirable effects on the central nervous system.
Very common (≥1/10): None
Very common (≥1/10): None
Common (>1/100, <1/10): None
Common (>1/100, <1/10): None
For details of uncommon, rare and very rarely reported adverse events and those of unknown frequency, see SmPC.
For details of uncommon, rare and very rarely reported adverse events and those of unknown frequency, see SmPC.
Reporting of adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie. Adverse reactions/events should also be reported to the marketing authorisation holder at the email address: pv.ireland@viatris.com or phone 0044(0)8001218267.
Reporting of adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie. Adverse reactions/events should also be reported to the marketing authorisation holder at the email address: pv.ireland@viatris.com or phone 0044(0)8001218267.
Legal Category: Subject to prescription which may be renewed (B)
Legal Category: Subject to prescription which may be renewed (B)
Reference: 1.EMA.Better training tools to support patients using adrenaline auto-injector. EMA/465403/ 2015. Available at: https://www.ema.europa.eu/en/news/better-training-tools-recommended-supportpatients-using-adrenaline-auto-injectors. Last accessed 06 March 2025.
www.viatris.ie
Reference: 1.EMA.Better training tools to support patients using adrenaline auto-injector. EMA/465403/ 2015. Available at: https://www.ema.europa.eu/en/news/better-training-tools-recommended-supportpatients-using-adrenaline-auto-injectors. Last accessed 06 March 2025. www.viatris.ie
Job code: IE-EPI-2025-00005
Job code: IE-EPI-2025-00005
Date of preparation: March 2025
Date of preparation: March 2025
Written by Dr Deirdre Philbin, Consultant in Emergency Medicine, Department of Emergency Medicine, Beaumont Hospital, Dublin Correspondence deirdrephilbin@rcsi.ie
CPD
60 Second Summary
Anaphylaxis is an acute, potentially life-threatening, generalised hypersensitivity reaction. Anaphylaxis is caused by the sudden release of mast cell and basophil derived mediators into the systemic circulation.
The most common triggers for anaphylaxis are food, drugs and venom. Anaphylaxis is a clinical diagnosis with acute onset of life-threatening airway, breathing and circulation compromise e.g. throat swelling, hoarse voice, wheeze, tachycardia, hypotension. This life-threatening condition is frequently under-recognised and unfortunately, under-treated.
The first line treatment of acute anaphylaxis is the immediate administration of intramuscular adrenaline. Additional treatments e.g. antihistamines, steroids have no role in treating life –threatening acute anaphylaxis and should be not be used until the patient has been stabilised. Any delay in the administration of adrenaline can result in fatality.
The specific test to help confirm a diagnosis of anaphylaxis is measurement of mast cell tryptase however measuring tryptase levels must not delay resuscitation. Following an appropriate period of observation, all patients with anaphylaxis in the hospital setting should be referred to a specialist allergy service on discharge. Input from specialist allergy service can help to identify the cause, and thereby reduce the risk of future reactions and prepare the patient to manage future episodes themselves.
1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?
2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.
3. PLAN - If I have identified a
knowledge gap - will this article satisfy those needs - or will more reading be required?
4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs?
5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the
Acute Anaphylaxis
Introduction
Anaphylaxis is an acute, potentially life-threatening, generalised hypersensitivity reaction.1 It is the most severe clinical presentation of acute systemic allergic reactions. Anaphylaxis is caused by the sudden release of mast cell and basophil derived mediators into the systemic circulation.2
Acute anaphylaxis is rare; the lifetime prevalence of anaphylaxis in Europe is estimated at 0.3%.3 It is also estimated that 1 in 300 people will experience anaphylaxis at some point in their life.3 Evidence suggests that anaphylaxis presentations to the Emergency Department continue to rise4 and it must be emphasised that any compromise in the care of these patients can result in fatality.
This life-threatening condition is frequently under-recognised and unfortunately, under-treated. There are approximately 20 deaths reported each year due to anaphylaxis in the UK, although this may be a significantly under-estimate.5
The Resuscitation Council UK have issued guidelines on the emergency treatment of anaphylaxis6 which focus on the life-threatening nature of anaphylaxis, the importance of recognition and the immediate
administration of adrenaline. In addition, the National Institute for Health and Care Excellence (NICE) have issued a quality standard for care after emergency treatment for suspected anaphylaxis, including assessment and referral to specialist allergy services.7
Definition of Anaphylaxis
The World Allergy Organisation (WAO) Anaphylaxis Committee has proposed the following definition:8 “Anaphylaxis is a serious systemic hypersensitivity reaction that is usually rapid in onset and may cause death. Severe anaphylaxis is characterised by potentially lifethreatening compromise in Airway, Breathing and/or the Circulation, and may occur without typical skin features or circulatory shock being present.”
Anaphylaxis is caused by the sudden release of mast cell and basophil derived mediators into the systemic circulation.2 It most often results from IgE mediated reactions to food, medications and insect stings; however it can also be induced by agents or events that induce sudden, massive mast cell or basophil degranulation in the absence of immunoglobulins.9
The most common triggers for anaphylaxis are food, drugs and venom.10 Food is the most
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common cause of anaphylaxis in young people. Pre-schoolaged children have the highest rate of hospitalisation due to food anaphylaxis, but a disproportionately low rate of fatal outcomes. In the hospital setting, anaphylaxis to drugs must always be considered. Fatal anaphylaxis due to drugs is rare in children, and is highest in older adults.
Recognition of Anaphylaxis
Anaphylaxis remains a clinical diagnosis, therefore emphasis must be placed on early recognition. Many patients with anaphylaxis are not given the correct treatment because of failure to recognise anaphylaxis.11
Anaphylaxis is likely when ALL the following 3 criteria are met:
1. Sudden onset and rapid progression of symptoms – most reactions develop over minutes.
2. Airway and/or Breathing and/or Circulation (ABC) problems. An ABC approach should be followed, and any life-threatening problems treated as they arise.
Airway - throat and tongue swelling (pharyngeal / laryngeal oedema), hoarse voice, stridor, patient may complain of their “throat closing up”
3. Skin and / or mucosal changes – can be subtle or absent in 20% of anaphylactic reactions. There may also be gastrointestinal symptoms such as vomiting, abdominal pain and incontinence.
Airway Swelling of tongue/ throat, hoarse voice, stridor
Treatment should follow the Resuscitation Council UK anaphylaxis algorithm6 in Figure 1.
Patient Positioning
Patients should be placed in a lying flat or semi-recumbent position with leg elevation where possible.
Removal of Trigger e.g. stop infusion
Adrenaline
Intramuscular (IM) adrenaline is first line treatment for anaphylaxis (even if intravenous access is available). The dose of adrenaline used to treat adults with anaphylaxis is 0.5ml (500micrograms) of 1mg/ml Adrenaline (1: 1000)
Administration of a single dose of IM adrenaline is usually well tolerated and poses minimal risk in the context of an individual having an allergic reaction.12
The best site for IM injection is the anterolateral aspect of the middle third of the thigh.13 The needle used for injection must be sufficiently long to ensure that the adrenaline is injected into muscle i.e. use a 21G or 23G needle. Monitoring (pulse, blood pressure, ECG, pulse oximetry) should be attached as soon as possible to help assess the patient’s response to adrenaline.
Download this algorithm: https://www.resus.org.uk/sites/default/files/2021-04/Anaphylaxis%20algorithm%202021.pdf
The IM adrenaline dose should be repeated if there is no improvement in the patient’s condition. Further doses should be given at about 5-minute intervals, depending on the patient’s
response. (There can be large inter-individual variability in the response to adrenaline.)
If features of anaphylaxis persist despite two doses of IM adrenaline, the patient should be treated for
refractory anaphylaxis and an adrenaline infusion should be commenced with expert support.
Emergency treatment of anaphylaxis | May 2021 10
The treatment for acute anaphylaxis is immediate administration of intramuscular
Figure 1: Resuscitation Council UK anaphylaxis algorithm. Reproduced with the kind permission of Resuscitation Council UK
adrenaline. It is important to note that any additional treatments are adjuncts and should not delay the administration of adrenaline.
Oxygen
Oxygen should be administered using a mask with an oxygen reservoir to maintain saturations 94-98%. If intubation is required to secure the airway, or to oxygenate adequately, then it is likely to be a difficult airway and appropriately experienced staff must be available.
Fluids
In the presence of hypotension/ shock, or poor response to an initial dose of adrenaline, a rapid IV fluid bolus of 5001000ml of crystalloid should be administered. Up to one third of the circulating volume may be lost through extravasation and fluid redistribution during anaphylaxis causing hypotension and shock. A large volume (up to 3-5 litres) may be required.
Antihistamines
Antihistamines are not recommended as part of the initial emergency treatment of anaphylaxis. They have been shown to be of no benefit in treating life-threatening acute anaphylaxis and should not be used until the patient has been stabilised.14 Many guidelines express concern that administration of antihistamines could delay the administration of adrenaline and thus contribute to morbidity.
H1 antihistamines may be used to help alleviate cutaneous symptoms after the patient has been stabilised. A non-sedating oral antihistamine e.g. cetirizine should be used in preference to chlorphenamine which was traditionally used.14 Antihistamines should be administered via the oral route where possible.
Steroids
Routine administration of corticosteroids is not recommended. There is no strong evidence that corticosteroids help shorten protracted symptoms or prevent biphasic reactions.15 Early administration of steroids in anaphylaxis is associated with an increased risk of intensive care admission, even after adjusting for severity of initial presenting symptoms.16 Oral steroids may be beneficial where an acute asthma
exacerbation may have contributed to the severity of the reaction.
Further management
Once stabilised, further management may include serial tryptase measurement, observation for biphasic reactions, anaphylaxis education and referral to specialist allergy services. NICE have issued a clinical guideline for management after emergency treatment for suspected anaphylaxis.7
Tryptase levels
The specific test to help confirm a diagnosis of anaphylaxis is measurement of mast cell tryptase. Tryptase is the major protein component of mast cell secretory granules. During anaphylaxis, mast cell degranulation leads to an increase in blood tryptase concentrations.17 Tryptase levels are not required for the initial recognition and emergency treatment of anaphylaxis. Measuring tryptase levels must not delay resuscitation. Tryptase levels can be helpful however for the specialist allergy service for their follow-up management of suspected anaphylaxis. Tryptase levels may confirm the diagnosis of anaphylaxis and ensure appropriate ongoing care. The timing of tryptase levels is important. Tryptase concentrations in the blood may not increase significantly until 30 minutes or more after the onset of symptoms, and peak 1-2 hours after onset.18 NICE guidelines7 recommend that a sample for tryptase level should be taken as soon as possible after emergency treatment has started and a second sample ideally within 1 to 2 hours (but no later than 4 hours) from the onset of symptoms. It is again emphasized that resuscitation should not be delayed to take samples.
Biphasic reactions
NICE guidelines7 for anaphylaxis management recommend that adults and young people aged 16 years or older who have had emergency treatment for suspected anaphylaxis should be observed for 6 to 12 hours from the onset of symptoms, depending on their response to treatment. In people with reactions that are controlled promptly and easily, a shorter observation period may be considered provided that they receive appropriate postreaction care prior to discharge.19 All patients should be reviewed by a senior clinician and a
decision made about the need for further treatment and duration of observation. Patients are observed during this time period for biphasic reactions. Biphasic reactions refer to the phenomenon that anaphylaxis can appear to resolve but then a recurrence of symptoms can occur several hours later in the absence of further allergen exposure. It is estimated to occur in 5% of patients.20 Published studies report the median time to biphasic symptoms (i.e. time by which 50% of biphasic reactions have occurred) to be approximately 12 hours.20 Patients who have a biphasic reaction or those who are at particular risk of a biphasic reaction should be admitted to hospital for observation. Risk factors for biphasic reactions following anaphylaxis include a more severe initial presentation of anaphylaxis, initial reaction needing more than one dose of adrenaline and a delay in adrenaline administration (>3060 minutes from symptom onset).21
Risk factors for biphasic reactions
• Severe initial presentation of anaphylaxis
• Initial reaction needing > 1 dose of adrenaline
• Delay in adrenaline administration (>30-60 mins from symptom onset)
Table 2: Risk factors for biphasic reactions
Specialist Referral and Anaphylaxis Education
All patients with anaphylaxis in the hospital setting should be referred to a specialist allergy service on discharge. Input from specialist allergy service can help to identify the cause, and thereby reduce the risk of future reactions and prepare the patient to manage future episodes themselves. NICE guidelines7 recommend that patients should be provided with appropriate adrenaline injector as an interim measure before the specialist allergy service appointment. They also recommend that patients with adrenaline auto-injectors should have two devices available at all times. Patients should be provided with an anaphylaxis patient information leaflet as well as an Emergency Management or Action Plan on discharge.
What have we learned?
What are the symptoms of acute anaphylaxis?
Anaphylaxis is a clinical diagnosis with acute onset life-threatening airway, breathing and circulation compromise. These include Airway - throat and tongue swelling (pharyngeal / laryngeal oedema), hoarse voice, stridor, patient may complain of their “throat closing up”
Immediate administration of intramuscular (IM) adrenaline is first line treatment for anaphylaxis. The dose of adrenaline used to treat adults with anaphylaxis is 0.5ml (500micrograms) of 1mg/ml Adrenaline (1: 1000).
Neither antihistamines nor steroids have a role in the emergency treatment of anaphylaxis. Any delay in adrenaline administration may result in fatality.
What is the next treatment step if there is no response to IM adrenaline administration?
The IM adrenaline dose should be repeated if there is no improvement in the patient’s condition. Further doses should be given at about 5-minute intervals, depending on the patient’s response.
If features of anaphylaxis persist despite two doses of IM adrenaline, the patient should be treated for refractory anaphylaxis and an adrenaline infusion should be commenced with expert support.
Who is at risk of biphasic reactions?
Risk factors for biphasic reactions following anaphylaxis include a more severe initial presentation of anaphylaxis, initial reaction needing more than one dose of adrenaline and a delay in adrenaline administration (>30-60 minutes from symptom onset).
Should all patients with anaphylaxis be referred to specialist allergy services?
All patients with anaphylaxis should be referred to a specialist allergy service. Input from specialist allergy services can help to identify the cause of anaphylaxis, and thereby reduce the risk of future reactions and prepare the patient to manage future episodes themselves. Patients should be provided with two adrenaline injectors as an interim measure before the specialist allergy service appointment.
Useful resources
Resuscitation Council UK anaphylaxis
IAEM Clinical Guideline Anaphylaxis
Anaphylaxis.org.uk
References
1 Yu JE, Lin RY. The Epidemiology of Anaphylaxis. Clin Rev Allergy Immunol. 2018;54(3):366.
2. Sampson HA, Muñoz-Furlong A, Campbell RL, et al; Second symposium on the definition and management of anaphylaxis: summary report-Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006;117(2):391.
3. Panesar SS, Javad S, de Silva D, et al; EAACI Food Allergy and Anaphylaxis Group. The epidemiology of anaphylaxis in Europe: a systematic review. Allergy. 2013;68(11):1353-61.
4. Baseggio Conrado A, Lerodiakonou D, Gowland MH, Boyle RJ, Turner PJ. Food Anaphylaxis in the United Kingdom: an analysis of national data, 1998- 2018. BMJ (under review)
5. Pumphrey R, Anaphylaxis: can we tell who is at risk of a fatal reaction?
Curr Opin Allergy C 2)lin Immunol. 2004;4(4):285.
6. Resuscitation Council UK Emergency Treatment of Anaphylaxis Guidelines for healthcare providers, Working Group of Resuscitation Council UK, May 2021 2021 Resuscitation Guidelines | Resuscitation Council UK
7. Anaphylaxis: assessment and referral after emergency treatment Clinical guideline [CG134]; December 2011 https://www.nice.org.uk/guidance/cg134
8. Cardona V, Ansotegui I, Ebisawa M, et al, on behalf of the World Allergy Organisation Anaphylaxis Committee.
Anaphylaxis Guidance 2020. World Allergy Organization Journal 2020; doi:10.1016/j.waojou.2020.100472.
9. Johansson SG, Bieber T, Dahl R et al; Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol. 2004;113(5):832.
10. Turner PJ, Gowland MH, Sharma V, et al. Increase in anaphylaxis-related hospitalizations but no increase in fatalities: an analysis of United Kingdom national anaphylaxis data, 1992–2012. J Allergy Clin Immunol. 2015; 135(4):956–63.e1.
11. Haymore BR, Carr WW, Frank WT. Anaphylaxis and epinephrine prescribing patterns in a military hospital: underutilization of the intramuscular route. Allergy Asthma Proc 2005;26(5):361-5.
12. Cardona V, Ferré-Ybarz L, Guilarte M, et al. Safety of Adrenaline Use in Anaphylaxis: A Multicentre Register. Int Arch Allergy Immunol. 2017; 173(3):171177.
13. Simons FE, Gu X, Simons KJ. Epinephrine absorption in adults: intramuscular versus subcutaneous injection. J Allergy Clin Immunol 2001;108(5):871–3.
14. Sheikh A, Ten Broek V, Brown SG, Simons FE. H(1)-antihistamines for the treatment of anaphylaxis: Cochrane systematic review. Allergy 2007;62(8):830-7.
15. Lee S, Bellolio MF, Hess EP, Erwin P, Murad MH, Campbell RL. Time of Onset and Predictors of Biphasic Anaphylactic Reactions: A Systematic Review and Metaanalysis. J Allergy Clin Immunol Pract. 2015;3(3):408- 16.e162. doi:10.1016/j.jaip.2014.12.010).
16. Gabrielli S, Clarke A, Morris J, et al. Evaluation of Prehospital Management in a Canadian Emergency Department Anaphylaxis Cohort. J Allergy Clin Immunol Pract. 2019;7(7):2232-2238.e3. doi:10.1016/j.jaip.2019.04.018)
17.Francis A, Fatovich DM, Arendts G, et al. Serum mast cell tryptase measurements: Sensitivity and specificity for a diagnosis of anaphylaxis in emergency department patients with shock or hypoxaemia. Emerg Med Australas. 2018;30(3):366-374.
18. Schwartz LB. Diagnostic value of tryptase in anaphylaxis and mastocytosis. Immunol Allergy Clin North Am 2006;26(3):451-63
19. Brown SG. Cardiovascular aspects of anaphylaxis: implications for treatment and diagnosis. Curr Opin Allergy Clin Immunol 2005;5(4):359-64.
20. Kraft M, Scherer Hofmeier K, Ruëff F, et al. Risk Factors and Characteristics of Biphasic Anaphylaxis. J Allergy Clin Immunol Pract. 2020:S22132198(20)30794-7.
21. Liu X, Lee S, Lohse CM, Hardy CT, Campbell RL. Biphasic Reactions in Emergency Department Anaphylaxis Patients: A Prospective Cohort Study. J Allergy Clin Immunol Pract. 2020;8(4):12301238.
33 Cardiology Special Focus: Cardiometablic
Biomarkers to Support Personalised Health and Precision Nutrition in Cardiometabolic Disease
Written by Dr. Fiona McGillicuddy and Prof. Helen Roche
As obesity rates spiral towards 1 billion people globally, the healthcare system is grappling to deal with the rising rates of associated cardiometabolic complications from type 2 diabetes to cardiovascular disease (CVD) and even some forms of cancer. However, one of the most prevalent complications of obesity, that is often overlooked and underdiagnosed, is metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as NAFLD, which is estimated to affect ~66% of people living with obesity (PwO). MASLD progresses to a more inflammatory phase known as Metabolic Dysfunction associated Steatohepatitis (MASH) in 20-30% of individuals with MASLD and is a key gateway for progression to liver fibrosis and liver failure/ cancer. The true prevalence of MASH however is unknown due to the lack of non-invasive biomarkers to support population level screening. MASH has rapidly become one of the leading causes of liver transplants in western society, due predominantly to the unrelenting obesity pandemic. MASH also increases the risk of death from CVD which is the main cause of mortality in affected patients. Despite the prevalence and severe consequences of obesity-related liver disease there is only one recently approved FDA drug for MASH (which works in ~25% of patients). Therapeutics for MASH are therefore a major unmet need with a $35 billion market awaiting a successful therapy (compare this to the rather overcrowded diabetes and CVD pharmacotherapy markets where treatment options are in abundance!). GLP-1 agonists are particularly promising for the treatment of MASLD (by reducing liver fat), however they have to date shown limited capacity to reverse fibrosis (and notably don’t work in everyone). Given that 66% of PwO have MASLD, it is improbable that MASLD alone will justify the reimbursement of GLP-1 agonists, similar to the criteria for type 2 diabetes. This makes earlier detection of patients with MASH, prior to advanced fibrosis, particularly critical.
There are two major challenges that are limiting the development of new pharmacotherapies for MASH including 1) lack of non-invasive
biomarkers to aid diagnosis and 2) lack of understanding of disease pathogenesis. The only way to currently diagnose MASH is through an invasive liver biopsy which is painful, time-consuming, expensive and notoriously unreliable. Non-invasive imaging is useful for detection of both liver fat content and the degree of liver fibrosis but cannot capture that intermediate inflammatory phase of the disease prior to significant, and irreversible, damage to the liver. Clinical trials for new MASH therapeutics require screening of patients using liver biopsies with often only 10-20% of these patients ultimately fulfilling the clinical trial criteria meaning many patients are undergoing unnecessary and risky invasive procedures. Biomarkers that identify optimal patients, as well as monitor disease regression over the trial, would therefore help expedite clinical trial recruitment and efficacy monitoring, and importantly would ensure only patients with the highest likelihood of fitting clinical trial criteria undergo liver biopsies. To address this unmet need, Dr. McGillicuddy’s group at UCD (in collaboration with Prof. Stephen Pennington) has developed new biomarker panels that can sensitively differentiate between the different stages of liver disease (MASH and fibrosis). The group have developed a new platform-based technology that sensitively measures over one hundred proteins attached to high-density lipoprotein (HDL) particles. Over 70% of HDL particles (and their associated protein cargo) are derived from the liver and thus measuring the HDL proteome provides critical insights into the health of the liver, but within a non-invasive blood-test. This new technology is currently funded by an Enterprise Ireland Commercialisation Fund, and ‘MetHealth’ is a promising future spin-out from UCD that will offer services to clinicians and clinical trial partners to aid diagnosis of MASH and guide clinical trial recruitment. The goal of ‘MetHealth’ is to provide multiple biomarker panels to the market that can monitor a variety of metabolic diseases and provide clinicians with a key tool to aid easier diagnosis of liver disease. Clinical collaborators have been key to the success of this research
including many national partners (Prof. Carel le Roux, Prof. Donal O’Shea, Prof. Suzanne Norris, and Prof. James Gibney).
The second major challenge for MASLD is that it is an extremely heterogeneous disease and the pathogenesis is poorly understood. Obesity arising from poor diet and lifestyle factors have a major role in the pathogenesis and progression of MASLD. Nevertheless, there is huge diversity in terms of peoples’ sensitivity to dietary stressors and indeed responses to dietary interventions. Precision Nutrition seeks to understand how and why some people are uniquely sensitive to different fats, sugars, etc and to understand if different dietary interventions are more efficacious for different disease subtypes. Prof Helen Roche’s team in collaboration with colleagues in SJH (Prof Suzanne Norris) are investigating the immunometabolic response of people living with MASLD and MASH to fat and fructose challenges –interestingly this work shows that the immuno-metabolic response of individuals to both dietary fat and fructose challenges is very different between people living with simple steatosis (MASLD), compared to those with the more progressed MASH phenotype. Important mechanisms that explain differences between subjects innate immune response is currently under investigation.
On the dietary intervention side, we know from previous work that very targeted dietary advice for specific phenotypes is much more effective. An observation which lead to our focus on ‘Precision
Nutrition’. Roche’s team led a very large pan European study in some 480 participants, which showed that people with the metabolic syndrome, who most probably had MASLD according to current criteria, greatly benefitted from removing dietary saturated fats from the diet, which were replaced by either more healthful monounsaturated and polyunsaturated fats, with complex carbohydrate, that would typify a Mediterranean Diet. In contrast, individuals with obesity but who did not display hepatic insulin resistance did not respond to the same intervention. Taking these learnings, an on-ongoing dietary intervention study at SJH and SVUH (with Prof. Aiden McCormick’s team) is determining whether time-restricted eating (TRE) (restricting eating to an 8-hour window within any 24h day) may be of benefit to people with MASLD. Studies suggest this regulation may be beneficial to aid weight regulation, however its impact on immuno-metabolism in people living with MASLD is as yet unknown. We’ll update you with results when we finalise our study! There is no doubt that new biomarker platforms, such as that provided by MetHealth, could revolutionize the identification of high-risk patients who need priority dietetic and pharmacological interventions. Furthermore, given MetHealth’s accuracy in discriminating different phenotypes of MASLD, Prof Roche predicts that this clinical biomarker companion tool could be of great benefit in terms of defining and refining efficacy of both food and pharma interventions.
Professor Helen Roche, Director UCD Conway Institute, University College Dublin
Dr. Fiona McGillicuddy, Cardiometabolic Research Group, Diabetes Complications Research Centre, University College Dublin
Cardiology Special Focus: Digital Health
Digital Health for CVD prevention
Introduction
The rapid evolution of digital health technologies is revolutionising the management of cardiovascular disease (CVD), providing innovative solutions for primary and secondary prevention of CVD. From telemedicine and wearable devices to artificial intelligence (AI) and big data, digital health is reshaping patient care, enabling early detection, personalised treatment, and improved outcomes.
Understanding Digital Health Digital health encompasses a broad spectrum of technologies designed to enhance healthcare delivery. Key components include telemedicine, remote monitoring, wearable technology, AI, big data analytics, and electronic health records (EHRs).1 These tools facilitate continuous patient engagement, data-driven decision-making, and improved accessibility to care. Wearable devices, such as smartwatches and fitness trackers, have become pivotal in monitoring heart rate, physical activity, and other vital parameters.2 AI-driven models offer predictive insights, improving risk stratification and early disease detection.3 Meanwhile, electronic health records enhance data management, ensuring seamless communication between healthcare providers and with patients.4
CVD Prevention
CVD prevention has significantly benefited from digital technologies. AI-powered risk prediction models help identify individuals at high risk of developing heart disease, allowing for early intervention.3 Wearable devices and mobile health applications can encourage lifestyle modifications by tracking
Written by Professor Lis Neubeck, Head of the Centre for Cardiovascular Health, School of Health and Social Care, Edinburgh Napier University
physical activity, dietary habits, and stress levels.5 Persuasive technology can also play a crucial role in behaviour change by employing convincing and effective communication strategies.6 Smartwatches and wearables equipped with photoplethysmography can detect irregular heart rhythms. prompting users to seek medical attention. Smartphone cameras7, 8 and voice analysis applications have also emerged as novel diagnostic tools.9 AI-powered algorithms enhance the accuracy of detecting conditions such as atrial fibrillation (AF) by analysing vast amounts of data from wearable devices.10 The widespread adoption of mobile health applications has demonstrated that behaviour change is most effective when applications are user-friendly, engaging, and integrated into daily life.11
Early and accurate diagnosis is critical in managing CVD. AI-assisted interpretation of electrocardiograms (ECGs) and echocardiograms enables clinicians to detect abnormalities with greater accuracy. Machine learning algorithms improve the early detection of arrhythmias, such as AF,12 facilitating timely intervention and reducing the risk of complications. Blood pressure monitors and other smart health tools also contribute to comprehensive cardiovascular assessment.13 Digital health technologies have also improved the management of heart failure through teleconsultations, remote rehabilitation programs, and wearable monitoring devices.14 Patients with heart failure benefit from remote haemodynamic monitoring, which enables early detection of fluid retention and
other warning signs.14 Digital scales, wearable sensors, and teleyoga programs contribute to holistic disease management, promoting physical activity and overall well-being.15 The integration of AI enhances predictive analytics, allowing clinicians to personalise treatment plans and optimise patient care.3
Telemedicine enables remote consultations, reducing the need for in-person visits while ensuring continuity of care.16 AI-driven decision support systems assist clinicians in making informed treatment decisions based on real-time patient data. Implantable devices, such as implantable cardioverter-defibrillators (ICDs) and pacemakers, are now equipped with remote monitoring capabilities.17 These devices allow healthcare providers to track patient status, adjust therapies as needed, and promptly address any complications. Telemedicine also plays a crucial role in medication adherence, supporting patients in maintaining their prescribed treatment regimens.16
Benefits of Digital Health in CVD
The implementation of digital health technologies offers numerous advantages in cardiovascular care. Equitable access to care is one of the most significant benefits, as telemedicine and remote monitoring bridge geographical barriers, ensuring patients in remote areas receive timely medical attention.18 Digital tools empower patients to take an active role in their health, fostering adherence to treatment plans and lifestyle modifications. Remote monitoring minimises hospital visits and readmissions, resulting in cost savings for healthcare systems. AI-powered predictive models facilitate early diagnosis, reducing the burden of advanced-stage disease and associated complications.
Challenges and Barriers
Despite the significant benefits, digital health adoption in CVD management is not without challenges. One of the primary concerns is the increased burden on healthcare providers, as the influx of digital health data requires additional resources for analysis and interpretation.18 The sheer volume of data generated by wearables and remote monitoring
devices can overwhelm healthcare professionals, necessitating efficient data management strategies. The rapid evolution of digital health may result in a more reactive approach rather than proactive prevention efforts. Questions regarding data storage, ownership, and access remain critical concerns. Ensuring data security and patient confidentiality is paramount, requiring stringent regulatory frameworks.19
Future Recommendations
To maximise the potential of digital health in CVD management, several recommendations should be considered. Adopting a patient-centred approach is crucial, as digital health solutions should prioritise patient needs, preferences, and accessibility. Ensuring digital inclusion is essential to bridge the digital divide, making certain that all patients, regardless of socioeconomic status, can benefit from digital health innovations. Investment in AI-powered decision support should be encouraged to enhance clinical decisionmaking, improving accuracy and efficiency. Strengthening data protection regulations is necessary to safeguard patient data and address privacy concerns. Encouraging collaboration between healthcare providers, technology developers, and academia will drive innovation and improve healthcare delivery.
Conclusion
Digital health is transforming the landscape of cardiovascular disease prevention, diagnosis, and management. From AIdriven risk prediction models to wearable monitoring devices and telemedicine, technological advancements are enhancing patient care, improving accessibility, and reducing healthcare costs. However, challenges such as data management, privacy concerns, and healthcare provider burden must be addressed to ensure the successful integration of digital health into clinical practice. By adopting a patientcentred approach, fostering collaboration, and investing in AI-powered solutions, the future of cardiovascular care will be more efficient, equitable, and impactful. References available on request
Cardiology Special Focus: Heart Failure
Heart failure mangement medical and non-medical in the Irish healthcare system
Written by Zoe McCrudden, Sharon Maher and Ciara Cahill, ANP from IAHFN
Heart Failure (HF)
HF is a pathophysiological state in which an abnormality of cardiac function is responsible for the failure of the heart to pump blood at a rate adequate to meet the requirements of the tissue or can do so only from an elevated filling pressure. Although this syndrome has been extensively researched and intensively treated, it remains a significant health problem worldwide. There is an increasing incidence of heart failure in the aging population (Woods et al, 2008).The body depends on heart’s pumping action to deliver oxygen-and nutrient-rich blood to the body’s cells. With heart failure, the weakened heart cannot supply the cells with enough blood.
Heart Failure is a complex clinical syndrome manifested by shortness of breath or dyspnoea and fatigue, which may limit exercise tolerance. It causes fluid retention which may lead to pulmonary congestion and peripheral oedema. Some people can experience excessive coughing due to pulmonary congestion.
As Clinicians when assessing patients with heart failure we must always look for the cause of the heart failure. Any disorder that places the heart under an increased volume/ pressure load or that produces primary damage
or an increased metabolic demand on the myocardium may result in HF. By identify the underlying and the precipitating causes of HF and it can guide management and treatment:
• Coronary artery disease is the underlying cause of HF in two thirds of patients with systolic dysfunction.
• Hypertension is implicated in systolic and diastolic dysfunction. Up to 30% of the patients in the acute decompensated heart failure registry (ADHERE) had a hypertensive aetiology, this is more prevalent among
HEART FAILURE
the patients with normal EF (Sweitzer et al, 2008).
• Arrhythmias are common in patients with underlying structural heart disease and the typically precipitate HF. These arrhythmias may take the form of tachyarrhythmia (most common atrial fibrillation), marked bradycardia, heart blocks and left bundle branch block, ventricular arrhythmia.
• Other precipitating factors include systemic infection, anaemia and pulmonary emboli that all place increased metabolic and haemodynamic demands on the heart.
Administration of cardiac depressants or salt retaining drugs may precipitate HF, examples include corticosteroids and non-steroids antiinflammatory agents. Herceptin and other cardio toxic chemotherapy agents have been shown to affect ejection fraction also. Alcohol is a potent myocardial depressant and may be responsible for the development of Cardiomyopathy.
In the Latest ESC Guidelines heart failure have been divided into 4 different types, shown in Table one on page 36.
Incidences of Heart Failure
Heart Failure (HF) is a common medical condition that affects approximately 1%-2% of the adult
population in developed countries. There is an increasing incidence of heart failure as we age, reaching >10% in people over the age of 70 (Ponikowski et al, 2016). This can rise further to 20% in those over 80 years.
Heart Failure prognosis remains poor with heart failure in-hospital mortality rate of 6.4%, a 30-day after discharge mortality rate of 4.4% and a 2-year mortality rate of up to 40% (Tuppin et al, 2014).
Heart Failure is divided into 50% HFrEF (this would include HFimpEF) and 50% HFmrEF/ HFpEF.
There are 10,000 new cases of heart failure in Ireland each year and at least 90,000 people are living with the condition. Over 36% experience a five-year mortality, higher than most cancers and it accounts for an estimated 7% of all inpatient bed days in Irish Hospitals (Irish Heart Foundation 2023). However, this is a condition that can affect anyone at any age.
Worryingly, heart failure rates are set to double by 2040.
Medical management for patients with Heart Failure:
Pharmacotherapy is the cornerstone of treatment for heart failure, particularly HFrEF, and should be implemented before considering device therapy. There are three major goals of treatment for patients with HFrEF: i)
L-R Zoe McCrudden, Sharon Maher and Ciara Cahill
Cardiology Special Focus: Heart Failure
Incidences of Heart Failure
reduction in mortality, ii) prevention of recurrent hospitalisations and iii) improvement in clinical status, functional capacity and quality of life.
life, a reduction in the incidence of diabetes requiring insulin treatment and a reduction in the decline in eGFR (Granger et al., 2003). Additionally, the use of ARNI may allow a reduction in loop diuretic requirement.
Therefore, it is recommended that ACE-I or ARB is replaced by sacubitril-valsartan in ambulatory patients with HFrEF, who remain symptomatic despite optimal treatment. It is particularly important to remember that clinicians are required to apply for reimbursement approval for Sacubitril/Valsartan via the Primary Care Reimbursement Service (PCRS) on an individual patient basis (HSE, 2020).
• Beta-blockers:
improve survival, reduce the risk of heart failure hospitalisations and reduce symptoms in patients with heart failure.
Heart Failure (HF) is a common medical condition that affects approximately 1%-2% of the adult population in developed countries. There is an increasing incidence of heart failure as we age, reaching >10% in people over the age of 70 (Ponikowski et al, 2016). This can rise further to 20% in those over 80 years
Modulation of the reninangiotensin-aldosterone and sympathetic nervous system with angiotensin- converting enzyme inhibitors (ACE-I), angiotensin II type 1 receptor blockers (ARB) or an angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, mineralocorticoid receptor antagonists (MRA) and sodiumglucose co-transporter 2 (SGLT2) inhibitors has been shown to
The ESC HF guideline (McDonagh et al., 2021) recommends the use of an ARNI as a replacement for ACE-I/ARB in patients who still remain symptomatic on ACE-I/ARB, betablocker & MRA therapies. However, ARNI may be considered as a first line treatment instead of ACE-I/ARB.
Heart Failure prognosis remains poor with heart failure in-hospital mortality rate of 6.4%, a 30-day after discharge mortality rate of 4.4% and a 2-year mortality rate of up to 40% (Tuppin et al, 2014).
drugs shown to reduce mortality and morbidity in patients with HFrEF. They have also been shown to improve symptoms. They are recommended in all patients, unless contraindicated or not tolerated. In this instance, ARB can also be used in these patients. They should be uptitrated to maximum tolerated doses (CONSENSUS trial study group, 1987; Packer et al., 1999; MERITHF study group, 1999).
Heart Failure is divided into 50% HFrEF (this would include HFimpEF) and 50% HFmrEF/ HFpEF.
• Angiotensin-converting enzyme inhibitors:
ACE-Is were the first class of
• Angiotensin receptorneprilysin inhibitor:
There are 10,000 new cases of heart failure in Ireland each year and at least 90,000 people are living with the condition. Over 36% experience a five-year mortality, higher than most cancers and it accounts for an estimated 7% of all inpatient bed days in Irish Hospitals (Irish Heart Foundation 2023) that can affect anyone at any age.
Worryingly, h
Medical management for patients with Heart Failure:
ARNIs show an improvement in HF symptoms and quality of
Beta-blockers have been shown to reduce mortality and morbidity in patients with HFrEF, in addition to treatment with an ACE-I and diuretic (Packer et al., 2002; Hjalmarson et al., 2000). They also improve symptoms. Beta-blockers should be initiated in clinically stable, euvolaemic patients at a low dose and uptitrated to maximum tolerated dose. In patients admitted with acute decompensated heart failure, beta-blockers should be initiated cautiously in hospital once the patient is haemodynamically stabilised.
• Mineralocorticoid receptor antagonists:
Pharmacotherapy is the cornerstone of treatment for heart failure, particularly HFrEF, and should be implemented before considering device therapy. There are three major goals of treatment for patients with HFrEF: i) reduction in mortality, ii)
MRAs (spironolactone or eplerenone) are recommended in addition to an ACE-I and betablocker, in all patients with HFrEF to reduce mortality and the risk of HF hospitalisation. They also improve symptoms. MRAs block receptors that bind aldosterone and other steroid hormones (Pitt et al., 1999).
• Sodium-glucose cotransporter 2 inhibitors: Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are the latest addition to guidelinedirected medical therapy in HF with reduced ejection fraction with recent trials suggesting a significant reduction in adverse cardiovascular outcomes in patients with HF with mildly reduced and preserved ejection fraction. They have been shown to reduce morbidity and mortality in HF and are effective across the spectrum of LVEF (McMurray et al., 2008; McDonagh et al., 2021).
As with all medications, it is best practice to monitor renal function when making adjustments to medications.
The above pharmacological therapies, refer primarily to HFrEF & HFmrEF. Management of HFpEF remains a little more challenging. To date, no treatment has been shown to definitively reduce morbidity and mortality in patients with HFpEF. In the absence of recommendations regarding disease modifying therapy, treatment should be aimed at reducing symptoms of congestion with diuretics (Omar et al., 2018; Kitzman et al., 2015).
• Diuretics:
Loop diuretics are recommended to reduce the signs/symptoms of congestion in patients with HF and are used across the entire spectrum of HFrEF, HFmrEF & HFpEF. The aim of diuretic therapy is to achieve and maintain euvolaemia. Diuretic dose will likely be adjusted based on close monitoring of symptoms, congestion and daily weight measurements (Vardeny et al., 2019; Mullens et al., 2019). SGLT2i are the most recent class of drug to show benefit to patients with HFpEF, as discussed above.
In addition to the pharmacological treatments outlined above, consideration should also be given to device therapy which will be appropriate in selected patients.
• Implantable cardioverterdefibrillator:
overall mortality and in some instances, may increase it (Connolly et al., 2000).
• Cardiac resynchronisation therapy:
In appropriately selected patients, CRT reduces morbidity and mortality. Furthermore, CRT improves cardiac function and enhances quality of life (Beggs at al., 2018). CRT is used in patients with HFrEF who have electrical dyssynchrony, typically evidenced by a prolonged QRS duration (≥150 ms) and left bundle branch block (LBBB) (McDonagh et al., 2021). This therapy involves implanting a pacemaker that coordinates the contraction of the left and right ventricles, improving cardiac efficiency and reducing symptoms.
Non-medical management of heart failure
Encouraging patients to take ownership of their heart failure through self-management is hugely important. It gives the patients confidence and enables a closer working relationship between the patient and their clinician. Which therefore helps to keep them well and their heart failure stable (Ponikowski et al 2016). The nonmedical management of heart failure is the same for types of heart failure.
care behaviours (National Heart programme 2021).
Self-care management in heart failure is a crucial aspect of improving outcomes for patients (Jaarsma 2021). It requires the ability to recognize changes in symptoms, like shortness of breath, swelling, or fatigue, and to act upon them in a timely and appropriate manner. This process involves both cognitive and behavioural components, where patients must not only identify symptoms of worsening HF but also decide on the necessary steps, such as adjusting medications, contacting a healthcare provider, or modifying daily activities.
Patients should be taught signs and symptoms of heart failure. A patient will be made aware of these during their initial appointment and will also be given written literature to support this. These include:
Patients should take note of their breathing and take note if they have increased breathlessness, particularly if they are experiencing paroxysmal nocturnal dyspnoea (waking up at night unable to breath or feeling very breathless).
Patients are often advised to stop using salt, this includes all types of salt as well reducing their general salt intake. They are often but not always placed on a daily fluid restriction. This is individualised and is usually set by the nurse specialists managing their condition. This is particularly important when a patient is prescribed intravenous fluids (Ponikowski 2014).
Patients are encouraged to have their annual seasonal vaccinations and routine vaccinations and immunisations.
Patients are often scared to exercise however this should be encouraged as exercise will improve their heart failure and heart failure symptoms (Täger 2014).
Checking for oedema: patients are encouraged to check their feet and legs. They are also advised to take note of any abdominal bloating, if the waist band on their clothes begins to feel tight or if their appetite is reduced. This is due to ascites caused by heart failure exacerbation. Some patients will only experience ascites, in severe cases they may report both oedema and ascites.
Patients should be compliant with their medications and should take these as they prescribed. Building a good relationship between clinician and patient will aide this. Common side effects from heart failure medication such as; erectile dysfunction and continence issues can be comfortably addressed. Giving patient’s information regarding their medication allows them to make a more informed choice and will aide adherence (Fitzgerald 2011).
A high proportion of deaths among patients with HF occur suddenly and unexpectedly. Many of these may be due to electrical disturbances, including ventricular arrhythmias. ICDs are effective at correcting potentially lethal ventricular arrhythmias (Shen et al., 2017). Some antiarrhythmic drugs might reduce the rate of tachyarrhythmias and sudden death but they do not reduce
Receiving a good initial education regarding diagnosis, prognosis and treatment plan from clinicians, usually the heart failure specialist nurse is an important first step. Education will all be individualised to every patient and their needs. Education is usually initiated during their hospital stay, and should include family members, friends or carers. It should then be re-iterated at subsequent appointments, by all care providers including their GP, practice nurse and heart failure specialist nurse. This will help to reinforce, support and encourage self-
consumption and follow the recommended daily intake as per HSE guidelines. Unless they have been told by to abstain from alcohol completely.
Smoking cessation of vapes and tobacco is always advised.
Self-management includes monitoring of weight daily. This should be recorded daily, first thing in the morning after using the bathroom. The patient will be given a dry weight, this is their weight when their heart failure is stable and they have no additional fluid (oedema). When recording their weight the patient should take note if there is a weight increase and contact their heart failure nurse or GP in accordance with their personal management plan.
Patients are advised to maintain a healthy weight and follow the Mediterranean diet by including lots of fruit and vegetable in their diet. They limit their alcohol consumption and follow the recommended daily intake as per HSE guidelines. Unless they have been told by to abstain from alcohol completely.
Smoking cessation of vapes and tobacco is always advised.
(National Heart Programme, Heart failure model of care 2021).
(National Heart Programme, Heart failure model of care 2021).
Cardiology Special Focus: Hyperlipidaemia
Hyperlipidemia and LDL-lowering: How low can we safely go?
As we here in Norway celebrate the 30 years anniversary of the 4S study (Scandinavian Simvastatin Survival Study),1 let us be reminded that this trial was the first ever to show that cholesterol lowering could prolong life in people who had established coronary heart disease (CHD). After randomization to either Simvastatin or placebo, the simvastatin group demonstrated a 35% reduction in LDL-cholesterol and a 30% reduction in all-cause mortality at a follow-up of 5.4 years. Of note, the starting LDL level in the two study arms was 5.2 mmol/L, and the achieved LDL level in the active treatment group came down to an LDL level of 3.1 mmol/L.
Over the three decades, as lipidlowering studies have expanded the scope of the populations investigated and the class of drugs utilized, we may push a fast-forward button to see that in the latest lipid-lowering studies, such as the FOURIER trial testing the PCSK9-inhibitor evolocumab, the average starting level in the study population with established atherosclerotic cardiovascular disease (CVD) was down at 2.3 mmol/L, reaching an average level of 0.8 mmol/L in the experimental arm of the trial. Hence, the baseline level of LDL was much lower than the achieved LDL in the 4S study.
This obviously raises the question: how low can we safely go in our LDL-lowering achievements. Three recent publications have shed light on this important question.
A major learning stems from the mentioned FOURIER study, where the study population on the experimental arm (evolocumab plus statin) had a significant
Dan Atar, MD, Dr.med.h.c., FESC, FACC, FAHA, FEHRA
Written by Dan Atar, Oslo University Hospital Ulleval, Dept. of Cardiology, Oslo, Norway, and Institute of Clinical Sciences, University of Oslo, Oslo, Norway
Head of Research and Professor of Cardiology
*Correspondence: Dan Atar, MD, Dr.med.h.c., Professor of Cardiology.
Oslo University Hospital Oslo, Norway
Phone: +47 – 221 19 18 7. Email: danat@uio.no
reduction in MACE compared to the statin only arm.2 The study was interrupted by the DSMB already after an average of 2.2 years since it became clear that there was an obvious benefit of the more intense LDL-lowering arm.
the ones with achieved LDL of 1.0 – 1.4 mmol/L and so on. And importantly, these extremely low LDL levels did not lead to an accumulation of harmful effects such as neurocognitive decline, malignancies, or muscle-related events. The only parameter that was statistically significant was a differential of all-cause mortality, in favor of the lowest LDL group. These findings are noteworthy as they reflect the mentioned long follow-up time.
adverse effects such as decrease in cognitive function or increase of malignancies, at least within the observation time of up to 8.6 years.
References
1. 4S study group: Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994 Nov 19;344(8934):1383-9.
Professor Dan Atar is Head of Research and Professor of Cardiology at the Oslo University Hospital in Norway. He graduate from Basel University, trained in internal medicine and cardiology in Switzerland, Denmark, and the US, and held a Post-doc position at the Johns Hopkins University in Baltimore (1991-94) and at the Universities of Copenhagen and Zurich, where he worked as a senior cardiologist. In 2002, he received a full professorship in cardiology at the University of Oslo and was appointed Head of Cardiology Dept. at the Aker University Hospital in Oslo, and since 2010 the Oslo University Hospital. He holds a Visiting Associate Professorship at the Johns Hopkins University in Baltimore, USA.
In certain countries, patients were then offered to enter FOURIEROLE (Open-Label Extension), which meant that all included patients were either continued on the PCSK9-inhibitor plus statin or shifted over from statin to PCSK9-inhibitor plus statin. The observation time with these additional 5 years of the FOURIER-OLE duration was hence significantly increased, allowing to make assessments of, e.g., endpoint accrual over time, safety of the long-term LDL-lowering exposure, and – not least –assessment of cognitive function.
Zimerman et al. published in 2024 their analysis of longterm neurocognitive safety of aggressive LDL-lowering, based on the same trial.4 A subgroup of patients of the parent FOURIER trial had been enrolled into a neurocognitive substudy (named EBBINGHAUS5), and their participation was extended into FOURIER-OLE. In this substudy, cognitive function was assessed annually, and the primary end point was change from baseline in executive function, measured by a score named ‘the spatial working memory strategy index score’. The result of this study manifested that the long-term exposure to very low levels of LDL, achieved via PCSK9 inhi¬bition and statin therapy, was not associated with cognitive impairment.
2. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators: Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):17131722.
Professor Atar has written over 560 articles and book chapters (H-index 89) and holds the fellowship-titles FESC, FACC, FEHRA and inaugural FAHA. He served as Chairman of the ESC Working Group on Cardiovascular Pharmacotherapy. He was chairing an EU-FP7 research consortium (Mitocare) to study reperfusion injury in STEMI. He was on several ESC guideline writing committees, amongst others the 2010, 2012 and 2016 ESC Guidelines on Atrial Fibrillation as well as the 2012 STEMI-guideline and the 2018 Universal Definition of AMI Guideline. In 2025, he will present the BETAMI trial (www.betami.org) which is currently running under his chairmanship.
Gaba et al. published in 2023 their analysis on the association between achieved LDL-levels and long-term cardiovascular and safety outcomes.3 It was demonstrated that prolonged treatment with the most efficient LDL-lowering combination therapy further reduced the risk of cardiovascular events. The estimated reduction in the classical MACE-endpoint (CV death, MI and stroke) is approximately 20% for every 1 mmol/L of LDL reduction. This figure has been known for a long time based on earlier meta-analyses. What is new now is that the achieved LDL-levels in FOURIER-OLE were far lower than any other previous study had explored. With a follow-up time of up to 8.6 years, the patients who had achieved an LDL of <0.5 mmol/L fared better than those with LDL of 0.5 – 1.0 mmol/L, and those fared again better than
Finally, the work by Al Said et al, published in 2025, sheds light on the question whether elderly patients with established CVD would still have a benefit of aggressive LDL lowering, or whether the advantage shown in the overall trial of FOURIER-OLE would be differentially expressed in those over 75 years.6 There were 9% of the total study population who were above the age of 75 years, and it turned out that the cardiovascular benefits were at least as good as those observed in younger patients, with a more favorable number needed to treat in older patients for reducing the composite endpoint and with no significant safety concerns.
3. Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, LopezMiranda J, Schiele F, Mach F, Flores-Arredondo JH, López JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS: Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203.
4. Zimerman A, O'Donoghue ML, Ran X, Im K, Ott BR, Mach F, Zavitz K, Kurtz CE, Monsalvo ML, Wang B, Atar D, Keech A, Sabatine MS, Giugliano RP: LongTerm Cognitive Safety of Achieving Very Low LDL Cholesterol with Evolocumab. NEJM Evid. 2025 Jan;4(1):EVIDoa2400112.
In 2012 Professor Atar was elected as Councillor and Board member of the ESC, in 2014 as Vice President of the ESC, and in 2018 as Treasurer of the ESC. For his scientific achievements, he earned a doctor honoris causa in 2015 and in 2016 he appeared on the prestigious Clarivate list of “the most cited researchers of the world”. He is currently chairing the European Heart Academy under the ESC and the FESC Task Force.
Taken together, the evolution of lipid lowering therapy points to even earlier start of treatment, and even more aggressive approaches in those patients where CVD already is established, in order to reduce cardiovascular events. This does not come at a cost of
5. Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR: Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med 2017;377:633-643
6. Al Said S, O'Donoghue ML, Ran X, Murphy SA, Atar D, Keech A, Flores-Arredondo JH, Wang B, Sabatine MS, Giugliano RP.: Long-Term Lipid Lowering With Evolocumab in Older Individuals. J Am Coll Cardiol. 2025 Feb 11;85(5):504-512
Further Training
39 Cardiology Special Focus: Coronary Bypass
We are in a position to offer proctoring to our sister institutions which will reduce the to go abroad to develop this new skill.
Our successful initiative sets the road map for the other cardiac surgery centres in the (public and private) and they can quickly learn from our experience and challenges introduction.
Endoscopic Vessel Harvesting for Coronary Artery Bypass Grafts Surgery
Our aim is to bring all the cardiac surgery centres in the country at par with the world centres.
Authors:
Written by Mr. Sadiq Siddiqui, Associate Specialist. Department of Cardiothoracic Surgery, University Hospital Galway and Mr Ronan Kelly. Consultant Cardiothoracic Surgeon, Department of Cardiothoracic Surgery, University Hospital Galway
Mr. Sadiq Siddiqui. Associate Specialist. Department of Cardiothoracic Surgery. University Galway. (For correspondence, email sadiq.siddiqui@hse.ie)
Coronary artery bypass grafting (CABG) remains the most commonly performed cardiac surgery procedure. Historically in 60s, CABG surgeries were performed using the Long Saphenous Vein grafts only. Early studies proved that the vein grafts were prone to failure due to intimal hyperplasia and premature atherosclerosis, thus resulting in poor patency rates.
Traditionally, the Long Saphenous Vein and Radial Artery were harvested via long incisions on the legs and forearms. The incision on the leg could be as long as 85 cms, making it the longest incision for any surgery (Fig. 1).
Patients undergoing CABG surgery have multiple co-morbidities. Diabetes, Chronic Kidney Disease and Peripheral Vascular Disease with amputations are common in these patients. Smoking and obesity are also common in this patient population (Fig. 2).
Patients undergoing CABG surgery have multiple co-morbidities. Diabetes, Chronic Kidney Disease and Peripheral Vascular Disease with amputations are common in these patients. Smoking and obesity are also common in this patient population (Fig. 2)
Endoscopic Vessel Harvesting for Coronary Artery Bypass Grafts Surgery
Written by Mr. Sadiq Siddiqui, Associate Specialist. Department of Cardiothoracic Surgery, University Hospital Galway & Mr Ronan Kelly. Consultant Cardiothoracic Surgeon, Surgery, University Hospital Galway
Coronary artery bypass grafting (CABG) remains the most commonly performed cardiac surgery procedure. Historically in 60s, CABG surgeries were performed using the Long Saphenous Vein only. Early studies proved that the vein grafts were prone to failure due to intimal hyperplasia and premature atherosclerosis, thus resulting in poor patency rates.
First Left Internal Mammary Artery (LIMA) was grafted to Left Anterior Descendant Artery (LAD) in 1968. Over the years this became the gold standard for CABG surgery and completely revolutionised the procedure. Radial Artery was first used in 1971. Early years of Radial Artery use were not promising due to early graft failure. Pathological reports showed intimal hyperplasia. Also, the Radial Artery harvesting technique was in its infancy. Over the next 20 years, surgeons learned that complete skeletonization, over handling of the Radial Artery, which results in trauma and spasm and mechanical dilatation of Radial Artery damaging the endothelium were the causes of early graft failure. The superiority of arterial grafts over vein grafts was further proven when evolution in surgery techniques using no touch technique and using pharmacological vasodilators instead of mechanical vasodilatation brought the Radial Artery patency rate at 10 years close to 90%.
First Left Internal Mammary Artery (LIMA) was grafted to Left Anterior Descendant Artery (LAD) in 1968. Over the years this became the gold standard for CABG surgery and completely revolutionised the procedure. Radial Artery was first used in 1971. Early years of Radial Artery use were not promising due to early graft failure. Pathological reports showed intimal hyperplasia. Also, the Radial Artery harvesting technique was in its infancy. Over the next 20 years, surgeons learned that complete skeletonization, over handling of the Radial Artery, mechanical dilatation of Radial Artery damaging the endothelium were the causes of early graft failure. The superiority of arterial grafts over vein grafts was further proven when e surgery techniques using no touch technique and using pharmacological vasodilators instead of mechanical vasodilatation brought the Radial Artery patency rate at 10 years close to 90%.
Traditionally, the Long Saphenous Vein and Radial Artery were harvested via long incisions on the legs and forearms The incision on the leg could be as long as 85 cms, making it the longest incision for any surgery (Fig. 1)
Needless to say, that these long incisions, especially on the legs, are prone to serious wound complications in this group of patients. Wound infection and hematoma post open vessel harvesting can range from 7% to 30% in different institutions (Fig. 3 on page 40).
Pain, delayed mobility and prolonged hospital stay add extra burden on health care system and stress on patients and their
families. Wound infections require antibiotics and expensive special Negative Pressure Wound Therapy (NPWT). Occasional need for Plastic Surgery procedures like wound debridement and skin grafting further add to patients’ stress and the expenses. We performed an audit in the Department of Cardiothoracic Surgery, University Hospital Galway. The audit showed that it takes on an average, 15,000 euros to treat one leg wound
Mr. Ronan Kelly
Fig. 1 Comparison of open leg and arm incision (left) with Endoscopic Vessel Harvesting incision (right)
Mr. Ronan Kelly. Consultant Cardiothoracic Surgeon. Department of Cardiothoracic
Fig. 1 Comparison of open leg and arm incision (left) with Endoscopic Vessel Harvesting incision (right)
Fig.2 Examples of complex patients
Fig.2 Examples of complex patients
Cardiology Special Focus: Coronary Bypass
Needless to say, that these long incisions, especially on the legs, are prone to serious wound complications in this group of patients Wound infection and hematoma post open vessel harvesting can range from 7% to 30% in different institutions (Fig. 3)
However, a number of additional studies have disagreed with these results. Some challenged the study’s conclusion and some questioned its methodology. Although it was published in a renowned journal, The New England Journal of Medicine, it had several limitations. It was not randomized for EVH vs open vein harvesting technique. Groups differed on patient risk factors related to long-term clinical outcomes. No standardization of harvest technique, harvester experience or centre volume were discussed. Also, patients were enrolled in 2002 and 2003 and since then significant advances in technology and technique has taken place.
How EVH is beneficial?
EVH is a technically challenging and intricate procedure. It has a steep learning curve like any other new surgical skill. As the learning curve gradually ascends, the path becomes smoother, and progress becomes more gradual. Continuously honing our skills and deepening our knowledge leads to greater mastery. With dedication and focus, one can achieve that level of proficiency.
EVH is endorsed by International Society of Minimally Invasive Cardiac Surgeons, ISMICS. It is also endorsed by European Association of Cardio-Thoracic Surgeons, EACTS. It is the DeFacto, standard of care in most of the hospitals in United States and United Kingdom.
Fig. 3 Wound infections after open vessel harvesting
infection after CABG surgery. Even if the wound heals without any complications, it leaves a long scar on the legs and the forearms.
Minimally Invasive Vessel Harvesting
Minimally Invasive Vessel Harvesting or more commonly,
Endoscopic Vessel Harvesting (EVH) was first introduced in 1995. In 2009, Lopes et al. reported significantly inferior clinical outcomes in patients receiving conduits obtained by EVH compared to traditional harvesting. This finding prompted a shift away from the use of EVH in many centres throughout Europe.
Pain, delayed mobility and prolonged hospital stay add extra burden on health care system and stress on patients and their families. Wound infections require antibiotics and expensive special Negative Pressure Wound Therapy (NPWT). Occasional need for Plastic Surgery procedures like wound debridement and skin grafting further add to patients’ stress and the expenses. We performed an audit in the Department of Cardiothoracic Surgery, University Hospital Galway. The audit showed that it takes on an average, 15,000 euros to treat one leg wound infection after CABG surgery. Even if the wound heals without any complications, it leaves a long scar on the legs and the forearms.
Minimally Invasive Vessel Harvesting
Then there was a paradigm shift. Same group of authors who had reported inferior clinical outcomes of EVH in 2009, later in 2012 reported that there was no difference in outcome in terms of mortality and revascularization between open vs EVH. In fact, they now reported that there was significantly reduced wound complications in EVH group.
EVH reduces cost by reducing requirement for wound care. Small 2cms wounds leave a better scar and results in good cosmesis. Wound infections after EVH are extremely rare. In our own experience in University Hospital Galway, we had no wound infections after almost 750 cases. Patients complain of minimal to
Fig. 4 Reduced Wound Care Resulting in Reduced Cost
No
Complications
Decreased wound infection
•Small scar/better cosmesis
•Less pain compared to open procedure
•Earlier ambulation
•Improved patient satisfaction
Less Resource Utilisation
Minimally Invasive Vessel Harvesting or more commonly, Endoscopic Vessel Harvesting (EVH) was first introduced in 1995. In 2009, Lopes et al. reported significantly inferior clinical outcomes in
No wound clinic visits
•No need for antibiotics
•No readmission for wound complications
•No requirement for expensive vacuum dressings
•Shortens length of stay
•Decreased cost per wound
Fig. 3 Wound infections after open vessel harvesting
Table 1: Patient Characteristics
Table 1: Patient Characteristics
Results
no pain compared to open vessel harvesting, resulting in early mobilisation and early discharge. All these factors lead to less resource utilisation. Patients after EVH do not require antibiotics, readmissions for wound management, expensive vacuum dressings, culminating into cost savings and improved quality of life (Fig. 4)
Procedure
In our unit, Pre EVH median length of stay was 12 days
One day of hospital stay costs of reduced hospital stay result in per patient. On an average, 100 EVH cases a year, 375000 euros annually (3 million euros since 2017)
During the pre-operative assessment, Ultrasound of the Long Saphenous vein and Radial Artery is essential for conduit quality, calcification, dimension and depth.
In our unit, Pre EVH leg wound infection 7%. infection rate dramatically dropped to
Cost to treat one wound infection 15000 euros. Annually we are saving 105000 euros (7 patients per year). Since 2017, our unit has saved euros in wound care.
Total savings 3.81 million euros sin
A small 2 cms incision is made below knee for Long Saphenous Vein and at second wrist crease for Radial Artery. A special device is used to harvest the vessels. After retrieval, side branches of the vessels are clipped or tied and injected with heparinised saline or heparinised blood, before grafting. EVH in University Hospital Galway
Only 3 out of 749 patients required prophylactic oral antibiotics for minor wound complications.
No patients had a delayed discharge due to EVH related complications.
In our unit, Pre EVH leg wound infection rate was 7%. After the introduction of EVH, the wound infection rate dramatically dropped to 0%
At 6 weeks OPD follow up, none of the patients had any wound complications Fig. 5 and 6 Further Training
Our unit is the first to safely introduce minimally invasive vessel harvesting for coronary artery bypass surgery in the HSE. Since 2017, we are successfully running it for the last eight years in University Hospital Galway. To learn this technique, the author travelled several times to Royal Brompton Hospital, London and John Radcliffe Hospital, Oxford.
Our unit started to perform Endoscopic Radial Artery Harvesting (ERAH) from October 2022.
To date, we have performed 749 EVH cases (645 veins and 104 radial arteries). Table 1
Results
In our unit, Pre EVH median length of stay was 12 days. Current median length of stay is 7 days.
One day of hospital stay costs 750 euros. 5 days of reduced hospital stay result in 3750 euros savings per patient. On an average, we perform 100 EVH cases a year, resulting in an annual savings of 375000 euros annually (3 million euros since 2017)
Cost to treat one wound infection is 15000 euros. Annually we are saving 105000 euros (7 patients per year). Since 2017, our unit has saved 817000 euros in wound care.
At 6 weeks OPD follow up, none of the patients had any wound complications Fig. 5 and 6
We are in a position to offer proctoring to our sister institutions which will reduce the need of having to go abroad to develop this new skill.
Total savings 3.81 million euros since 2017
Only 3 out of 749 patients required prophylactic oral antibiotics for minor wound complications.
No patients had a delayed discharge due to EVH related complications.
Our successful initiative sets the road map for the other cardiac surgery centres in the country (public and private) and they can quickly learn from our experience and challenges with its introduction. Our aim is to bring all the cardiac surgery centres in the country at par with the world leading centres.
Fig.5 Endoscopic Vein Harvesting Scar after 6 weeks
Fig. 6 Endoscopic Radial Artery Harvesting Scar after 6 weeks
Fig.5 Endoscopic Vein Harvesting Scar after 6 weeks
Fig 6 Endoscopic Radial Artery Harvesting Scar after 6 weeks
Fig.5 Endoscopic Vein Harvesting Scar after 6 weeks
Fig 6 Endoscopic Radial Artery Harvesting Scar after 6 weeks
Cardiology Special Focus: Atrial Fibrillation
Innovative Procedure for Atrial Fibrillation
Brief description of atrial fibrillation
Atrial fibrillation (AF) is a common problem affecting 1-2% of the population. This incidence of atrial fibrillation increases as the patient ages. AF is often associated with other conditions as a secondary phenomenon. Most commonly, it is associated with cardiac conditions such as valvular heart disease or ischemic heart disease. Other commonly associated conditions include hypertension and hyperthyroidism.
AF is a significant disease, often leading to the triad of thromboembolism, reduced cardiac output and symptoms of palpitations. The most devastating complication of AF is thromboembolism. When the atrium fibrillates, there is stasis of the blood flow in both atrium especially in the left atrial appendage. Stasis of blood flow leads to clot formation and when it embolized, lead to stroke.
AF also lead to reduced cardiac output as a result of losing the contribution of atrial contraction, the “atrial kick”. This contributes roughly about 10% of the cardiac output. In AF, the atrium fibrillates and does not contract. When it persist, patients develop chronic heart failure leading to reduced life expectancy.
Lastly, AF can present with fast irregular heart rate with the patient experiencing severe palpitation symptoms.
Current management of AF is mainly medical with concentration on controlling the symptoms with anti-arrhythmic medication, and anticoagulation to prevent stroke. In some cases of very slow AF, a permanent pacemaker is required. However, despite anticoagulation,
Written
by Professor Alan Soo MD FRCSI FRCS(CTh), Consultant Cardiothoracic Surgeon, Clinical Lead, University Hospital Galway, Honorary Personal Professor, University of Galway
Cox-Maze procedure
This surgical procedure is effective in restoring sinus rhythm. However, it is associated with long surgery time, high risk of bleeding and in certain cases, risk of mortality. Hence a less invasive method was needed to improve the situation. This came in the form of radiofrequency ablation.
In this procedure, the surgeon will perform the procedure minimally invasively via a subxiphoid approach. In this approach, only a single 2-3 cm incision is required. A specialised probe allowed the delivery of an energy device to the back of the left atrium and ablate the back of the left atrium, an area where it is difficult to ablate via the percutaneous approach for reasons mentioned previously. This surgical approach is a safer less invasive approach as it does not require the encircling of the pulmonary vein. Also, multiple ablation attempt can be made to the left atrium with no significant risk the oesophagus. [Figure 3]
the incidence of stroke in patients suffering from AF is around 2-5%. Therefore, there is a need to revert these patients back to sinus rhythm.
Mechanism
The breakthrough in determining the mechanism of origin of AF was made by Michel Haissaguerre. His publication in the New England Journal of Medicine depicted the origin of AF as ectopic beats originating from the pulmonary veins. These ectopic beats coupled with micro reentry of wavelets leads to AF propagation. This formed the basis of pulmonary vein isolation as a treatment strategy for treatment of AF. [Figure 1]
Following the recognition of the mechanism of AF by Haissaguerre, a solution to AF was sought. Dr James Cox pioneered the so called “CoxMaze” procedure to isolate the ectopic and abberant electrical activity aiming to convert the patient back into sinus rhythm. This was initially performed as a surgical procedure. This surgical procedure is extensive and complex requiring the patient to be placed on cardiopulmonary bypass and the heart arrested, like other open heart procedures. During myocardial arrest, the left atrium is cut around the pulmonary vein to “isolate” it creating a “box” lesion. This contained the ectopic beats within the box to isolate it and preventing its propagation. Hence allowing normal sinus rhythm to be maintained. In this procedure, both the left and right atrial appendages are also removed to reduce the risk of thromboembolism. [Figure 2]
With the introduction of the radiofrequency technology that could be delivered using a clamp, surgeons were able to replicate the “lesions” created by the Coz Maze procedure without “cutting and sewing” the heart. This technique is technically less demanding and and hence safer and reproducible. There has since been an increased uptake of the technique since the introduction of the technology. At the time of writing this article, It is currently a class II indication to perform concomitant ablation with other cardiac surgical procedure such as CABG or aortic/mitral valve repair or replacement procedure. “Lone” AF ablation, described as ablative procedure performed solely for AF is only
Once the surgical part of the procedure is performed, the EP cardiologist can then performed the mapping procedure and ablate the remaining aberrant pathways reducing the amount of endocardial ablation required and hence improving the safety.
In the Convergent trial published in the New England Journal of Medicine in 2020, 153 patients were randomized 2:1 to Hybrid Convergent versus the percutaneous endocardial catheter ablation. All included patients had long standing persistent AF. These are patients that are the hardest to treat These patients often have low sinus rhythm conversion rates despite multiple catheter ablation procedures. In this study, there was a 67% relative improvement in freedom of AF. While the complication rate is slightly higher in the convergent group, it was insignificant and most importantly, there was no deaths, cardiac perforations, or atrioesophageal fistulas occurred. The authors concluded that “The Hybrid Convergent procedure has superior effectiveness compared to the Catheter Ablation for the treatment of persistent and long-standing persistent atrial fibrillation.” This represent a new paradigm for the treatment of AF especially long standing persistent AF.
Figure 1 Mechanism of AF
Normal Atrial Fibrillation
performed in selected expert centre. The success rate of this procedure is greater than 70% and is often performed in conjunction with left atrial appendage occlusion or closure.
While concomitant AF ablation has more or less became the standard of care in patients undergoing open heart surgery with AF, not many centres perform “lone” AF procedure surgically. This is partly due to the ability of the electrophysiologist to perform the similar procedure percutaneously.
With the introduction of transcatheter technique, cardiologist specialising in atrial fibrillation ablation can maneouvers the catheter into the left atrium via a transseptal puncture through the interatrial septum. Once transseptal puncture is performed, access to the left atrium and pulmonary veins is attained percutaneously. The EP cardiologist can then perform a “mapping” procedure to determine the location of the
aberrant pathways contributing to the patient’s AF. Then, the EP cardiologist use an energy device to deliver specific energy to target these aberrant pathways and ablate it to abolish the AF. The most frequently used energy source is radiofrequency. Lately, pulse field ablation had been introduced with supposedly improved safety.
Surgical AF ablation is invasive and therefore comes with potential mortality and morbidity. Therefore, in most centres, AF ablation is
limited to concomitant use only. Only in certain large centres and specialist centres, “lone” AF ablation is carried out surgically. The conversion to sinus rhythm rate is in the region of around 70-80% depending on the chronicity of AF and size of left atrium. As for catheter ablation, the risk of mortality is negligible and the rate of complication is significantly lower compared to surgery. However, catheter ablation, despite the mapping performed, has a lower sinus rhythm conversion rates compared to surgery. On some occasion, multiple ablative attempts is required. This is mainly due to the fact that the energy device used in these endocardial ablative procedure are not suitable to be applied directly on the wall of the left atrium as it could induced injury to both the left atrial wall and the oesophagus. Both injuries are devastating injury.
Hybrid Convergent procedure
With the above mentioned problems with both surgery and catheter ablation in mind, a new innovative procedure was developed to overcome problems encountered in either procedure by combining the 2 procedures. This is known as the hybrid convergent procedure.
In this procedure, the surgeon will perform the procedure minimally invasively via a subxiphoid approach. In this approach, only a single 2-3 cm incision is required. A specialised probe allowed the delivery of an energy device to the back of the left atrium and ablate the back of the left atrium, an area where it is difficult to ablate via the percutaneous approach for reasons mentioned previously.
This surgical approach is a safer less invasive approach as it does not require the encircling of the pulmonary vein. Also, multiple ablation attempt can be made to the left atrium with no significant risk the oesophagus. [Figure 3] Once the surgical part of the procedure is performed, the EP cardiologist can then performed the mapping procedure and ablate the remaining aberrant pathways reducing the amount of endocardial ablation required and hence improving the safety.
In the Convergent trial published in the New England Journal of Medicine in 2020, 153 patients were randomized 2:1 to Hybrid Convergent versus the percutaneous endocardial catheter ablation. All included patients had long standing persistent AF. These are patients that are the hardest to treat. These patients often have low sinus rhythm conversion rates despite multiple catheter ablation procedures. In this study, there was a 67% relative improvement in freedom of AF. While the complication rate is slightly higher in the convergent group, it was insignificant and most importantly, there was no deaths, cardiac perforations, or atrioesophageal fistulas occurred. The authors concluded that “The Hybrid Convergent procedure has superior effectiveness compared to the Catheter Ablation for the treatment of persistent and long-standing persistent atrial fibrillation.” This represent a new paradigm for the treatment of AF especially long standing persistent AF.
The CONVERGENT Approach
Pericardial Reflections
Epicardial Lesions of Convergent Procedure
Endocardial Lesions of Convergent Procedure
Figure 2 The original cut and sew “Cox Maze” procedure
Figure 3 The CONVERGENT procedure
Figure 1 Mechanism of AF
Figure 2 The original cut and sew “Cox Maze” procedure
Cardiology Special Focus: CVD
Harnessing digital health for the secondary prevention of Cardiovascular Disease
With more individuals living longer with CVD, the need for comprehensive, effective, and timely access to secondary prevention care has never been more important. Nearly half of all CV events occur in patients with established CHD, with 18% experiencing a recurrent event in the first year after MI.1 Early initiation of evidence-based, secondary prevention lifestyle and pharmacological treatments, together with access to cardiac rehabilitation (CR)2, 3 can mitigate a large part of this risk providing an estimated gain of seven CV event free years, whilst improving quality of life, reducing rehospitalisation’s and costs.4, 5 However, in reality, only a minority of patients with CHD achieve optimal risk factor control and less than a half attend CR, usually several weeks or even months after hospital discharge. The promising role of digital health interventions (DHIs), including mobile health (mHealth) apps in addressing this implementation gap is increasingly recognised.6 Recent meta analysis data show that mHeath apps can improve CVD risk factor control, adherence to medication, quality of life, medication adherence, reduce hospital readmission and enhance self-management among patients with coronary heart disease.7-10 Consequently, various international organisations such as the World Heart Federation (WHF), European Society of Cardiology (ESC), American Heart Association (AHA), recommend the use of DHIs for the secondary prevention of CVD. Furthermore, the new Digital Health Framework for Ireland (2024-2030) emphasises the importance of harnessing digital
Written by Irene Gibson
technologies in re-orientating service delivery to support people to stay healthy or manage their chronic condition, including CVD.
However, while DHIs offer new opportunities for delivering secondary CVD care, their adoption into clinical practice has been slow and real world evaluations remain sparse. Furthermore, uptake and usage of DHIs among patients is low and it is estimated that 21% of mHealth app users only use an app once and 71% disengage within 90 days of downloading.11 Additional challenges of DHIs are that, the majority are designed with minimal input from target end users, the degree to which they follow evidence-based guidelines is unclear, and there is lack of understanding of the systems required to support implementation and scalability of these interventions.7, 12
To address these challenges, the National Institute for Prevention and Cardiovascular Health (NIPC) in collaboration with the University of Galway have developed a digital intervention known as “INTERCEPT”, which aims to improve secondary prevention in CHD patients. INTERCEPT includes an mHealth app which aims to support and motivate patients to achieve a healthy lifestyle, manage their CVD risk factors to target, and improve adherence with cardio protective medications. The app links to a healthcare professional portal to facilitate remote monitoring and support and integrates with a fitness wearable and a blood pressure monitor to enable self-monitoring in real time.
Responding to the need for early initiation of prevention after an index event,2 particularly given delays in patients accessing traditional (CR) programs,13, 14 INTERCEPT is designed to be introduced to the patient at the time of their acute hospitalisation and before discharge home. In this way, it provides a bridge to CR or an alternative for patients who choose not to join a CR programme.
To maximise the potential effectiveness of INTERCEPT, and to ensure it meets with the needs of the end user (patients and health care professionals) a theory and evidence-based approach to development, was adopted. A core interdisciplinary team of health care professionals (nurse specialists, physicians, physiotherapists, dietitians, psychologists and a pharmacist), software developers and patients from the Croí (heart and stroke patient organisation) public and patient advisory panel was established to oversee development. Through a series of online workshops, a 4-phase, iterative, co-design process which integrated the end users’ (patients and health care professionals) perspectives throughout was adopted, see figure 1.
Phase one involved planning and defining the aims and objective of INTERCEPT. In phase two the guiding principles, content, and design features of the DHI were agreed. This led to the development of the intervention prototypes in phase three, which were reviewed for clarity of language, ease of navigation and
Figure 1. Development process of INTERCEPT
functionality. Phase four involved a formal usability testing study with participants who had a recent cardiac event (<2 years). The aim was to anticipate and interpret intervention usage and outcomes, and accordingly modify the intervention to make it more persuasive, feasible, and relevant to users. Usability testing resulted in 64 recommendations for the app and of these 51 were implemented. Significant improvements in system usability scores were observed from 60.8 to 82.8 (p<0.001) suggesting that improvements on iterations from the co-design process were effective.
The components of the INTERCEPT app include: tailored goal setting to motivate and support healthy lifestyle change; a health tracker to support self-monitoring of physical activity, mood, healthy eating, medications, blood pressure, cholesterol and glucose levels; educational resources to increase knowledge and awareness of healthy lifestyle changes and adherence with cardio-protective medications and notifications to prompt engagement with the INTERCEPT. Screen shots of the app are presented in figure 2. Through informed consent, a CVD Nurse Specialist monitors patient engagement with the app through the portal dashboard. This data includes tracking of lifestyle and medical risk factors, goal setting and use of medication reminders. Given the strong focus of INTERCEPT in supporting and changing health behaviours its
development has been informed by social cognitive theory and select behaviour change techniques from the taxonomy of behaviour change techniques (BCTs).
In line with Medical Research Council (MRC) guidelines for the development and evaluation of complex interventions, a feasibility study of INTERCEPT has recently been conducted at the Cardiology Department of Galway University Hospital. The overall aim of this study was to examine the feasibility of INTERCEPT to help determine a) the acceptability of INTERCEPT to patients and health care professionals b) inform further refinement of the intervention, and (c) to determine the feasibility of a definitive randomized controlled trial (RCT). Using convenience sampling, eligible patients (n=40) were recruited and invited to download the INTERCEPT to their smartphone prior to hospital discharge. Primary outcomes were assessed at baseline and at 3-month follow-up, this included qualitative interviews among a subset of patients and health care professionals to gain insights into their experience of using INTERCEPT. While these outcomes are under review for publication the following are some qualitative insights from both patients and health professionals.
From a patient perspective their experience of INTERCEPT was mostly positive, with engagement being very much influenced by their individual needs and perspective on their recovery
Figure 2. Screenshots of the home screen, goal setting and health tracker
journey. Almost all patients reported that it was important to be introduced to INTERCEPT while in hospital, however having a follow-up support session within the first few weeks of discharge would have enhanced their confidence and understanding of the various components. Patients placed a significant value on the nurse portal, describing it as a “safety net” at a time of increased anxiety and reported being more likely to use the app and the wearable devices if their data were being monitored. Patients also reported that INTERCEPT helped to increase their self-confidence and self-efficacy around managing their cardiovascular health and this was very much aided by the health tracker section of the app and the self-monitoring tools such as the fitness wearable and BP monitor.
Insights from health professionals and researchers highlighted some key challenges. These related to the recruitment of patients in a busy acute clinical area, where patients are either discharged back to the referring hospital within hours of their procedure or home with 48 hours. This resulted in a limited window for recruitment. Furthermore, the processes associated with introducing the patient to the technology were time consuming and multiple technological challenges were encountered. These were mainly associated with integrating the wearable devices with the INTERCEPT App. These challenges are not unique to INTERCEPT and were
overcome through techncal support. Consistent with the evidence facilitators to app engagement related to family support and endorsement by health care professionals. While findings from this study highlight the value of DHIs including mHealth apps in offering innovative, scalable approaches that improve the provision of timely secondary prevention, factors infuencing implementation in a busy clinical environment must be considered. The proliferation of DHIs including mHealth has enabled the development of new and innovative approaches for the secondary prevention of CVD. However, careful attention to the development of these DHIs is required to increase their effectiveness and uptake in clinical practice. INTERCEPT is advancing knowledge both on the development of DHIs for the secondary prevention of CVD, and importantly the feasibility of introducing digital health to CHD patients in a critical care setting. Next steps are progression to definitive evlaution of effectiveness.
To learn more about the development of INTERCEPT the full text publication can be accessed here: https:// humanfactors.jmir.org/2024/1/ e63707
Gibson I, Neubeck L, Corcoran M, Morland C, Donavan S, Jones J, Costello C, Hynes L, Harris A, Harahill M, Lillis M, Atrey A, Ski CF, Savickas V, Byrne M, Murphy A.W, McEvoy J.W, Wood D, Jennings C. Development of a Digital Health Intervention for the Secondary Prevention of Cardiovascular Disease (INTERCEPT): Co-Design and Usability Testing Study
Dr. Irene Gibson is Head of Clinical Innovation at the NIPC. She is a recent graduate of the HRB funded Collaborative Doctoral Programme in Chronic Disease Prevention at the University of Galway. The focus of her PhD research was on the development of INTERCEPT.
References available on request
Cardiology Special Focus: Pulmonary Embolism
Pulmonary Embolism (PE) to Chronic Thromboembolic Pulmonary Disease (CTEPD):
Findings from a Survey of UK Physicians
Written by Joanna Pepke-Zaba1,Luke Howard2,David G. Kiely3,4,Shruti Sweeney5 andMartin Johnson6,*
1Pulmonary Vascular Diseases Unit, National Pulmonary Hypertension Service, Royal Papworth Hospital, Cambridge CB2 0AY, UK
2National Pulmonary Hypertension Service, Hammersmith Hospital, London W12 0HS, UK
3Sheffield Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield S10 2JF, UK
4Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, NIHR Biomedical Research Centre, Sheffield S10 2RX, UK
5Medical Affairs Department, Janssen-Cilag Ltd., High Wycombe HP12 4EG, UK
6Scottish Pulmonary Vascular Unit, Golden Jubilee National Hospital, Glasgow G81 4DY, UK
Chronic thromboembolic pulmonary disease (CTEPD) is a complication of acute pulmonary embolism (PE).1,2 More research has been conducted on CTEPD with pulmonary hypertension (PH) (chronic thromboembolic pulmonary hypertension, CTEPH), while the natural history of CTEPD without PH and how it relates to CTEPH are unclear.3 The cumulative 2-year incidence of CTEPH was recently estimated to be 2.3% in acute PE patients in the prospective, multicentre and observational FOCUS study,4 and the presence of PH confers a poorer prognosis. Left untreated, the historical 5-year survival rate for severe (mean pulmonary artery pressure: >50 mmHg) CTEPH is 10%.5
The modern treatment for CTEPH is multimodal: pulmonary endarterectomy (PEA), balloon pulmonary angioplasty and medical treatment for PH may be used singly or in combination.2 For those with a surgically accessible disease, PEA offers the best prospect of a cure.1 Using an international, prospective registry of CTEPH patients, it was found that the 3-year survival was 89% in operated patients (N = 404) versus 70% in non-operated patients (N = 275),6 and a UK study of 550 CTEPH patients found that the 5-year survival was superior in patients who underwent PEA (83%) versus patients who either declined surgery (53%) or were ineligible for surgery (59%).7 According to the treatment
guidelines, the possibility of CTEPH should be considered in all symptomatic patients with breathlessness after 3 months of therapeutic anticoagulation.2,8 Diagnostic algorithms for CTEPH recommend an echocardiographic assessment of the probability of PH, assessment of lung perfusion (e.g., using ventilation/ perfusion (V/Q) lung scintigraphy) and cardiopulmonary exercise testing (CPET).1,8,9,10 However, CTEPH awareness is low among PE-treating physicians,11,12,13 and CTEPH often goes undiagnosed for over a year,14 negatively impacting patient prognosis, with higher pulmonary artery pressures and an increased risk of death.15
We aimed to understand the level of awareness of CTEPD (with or without PH) among UK physicians and the current practices in the follow-up of patients presenting to hospital with PE. The key takeaways of this study are shown in Box 1.
Box 1. Key takeaways from the CONNECT survey of UK PEtreating physicians.
Box 1. Key takeaways from the CONNECT survey of UK PEtreating physicians.
• CTPA is most often used as the first-line of investigation for CTEPD fol-lowing PE despite cardiac echocardiography and V/Q scintigraphy being recommended;
• CTEPH was ranked as the most common cause for persistent
breathless-ness post-PE despite it being relatively rare compared to other issues such as deconditioning. This may lead to onward referrals without the appro-priate investigations being conducted;
• Haematologists with an interest in thrombosis should be involved in the PE follow-up pathway;
• Protocols for PE follow-up should highlight the need for a retrospective review of the CTPA from the initial PE assessment;
• Hospital protocols should ensure smooth integration of their PE care pathways and ensure that physicians are aware of their nearest specialist PH centre.
Materials and Methods
This was a cross-sectional online survey of PE-treating pulmonologists, cardiologists, haematologists and internal medicine specialists (other hospital departments were excluded) in the UK (other countries excluded), performed between 2 December 2021 and 24 January 2022. Eligible physicians were either Specialty Registrars or Consultants (other job titles excluded); had been working in their specialty for 3–40 years; were based in a district general hospital, teaching hospital, PH centre or PH shared care centre in the UK (other primary work settings excluded); and personally managed ≥10 PE cases in a typical year (those
managing fewer than 10 cases were excluded). Participants were advised that their personal information would not be passed to a third party without their permission, that personal data would be destroyed after 2 years and that they had the right to withhold information or withdraw at any time. Participants were also informed that the research was treated in accordance with the European Society for Opinion and Marketing Research (ESOMAR) and the Market Research Society (MRS)’s Code of Conduct, that all data would be anonymised and that they would not be asked to provide data on an individual patient. Participants were advised that the survey findings were intended to be shared externally, including publication in a relevant peer-reviewed journal. Finally, participants were informed that it would be a requirement that any possible adverse events, product complaints or special reporting situations related to the study sponsor’s products were passed on (anonymously), even if already reported via the Medicines and Healthcare products Regulatory Agency’s (MHRA) ‘Yellow Card’ system, and they were asked if they would still like to proceed. The survey was conducted by Sermo using the Decipher survey platform (FocusVision) and developed by the authors. It consisted of seven screening questions: two background questions, 10 questions on PE management and 14
questions on experience in evaluating suspected CTEPD (Supplementary Materials). The questions used nomenclature following the European Respiratory Society statement on CTEPH, including the term ‘CTEPD’ rather than ‘chronic thromboembolic disease’.16 The questionnaire took approximately 20 min to complete, and respondents were remunerated for their participation in accordance with fair market value rates.
Results
The target of 175 physicians completing the questionnaire was reached: 50 each from respiratory medicine, cardiology and internal medicine, plus 25 from haematology. The response rate of the individuals approached for this
study was 11%. The respondents were mainly consultants (88%) based in district general or teaching hospitals (82%).
Eighty-nine percent reported that their centre had local guidelines on PE management. The percentage of physicians reporting that their centre had a PE response team (PERT) ranged from 14% (internal medicine) to 54% (respiratory medicine).
All but two physicians reported access to computed tomography (CT) imaging (two selected “not sure which, if any, [CT] modalities are available”), while—of the nuclear medicine modalities—77% had access to V/Q scanning, 10% Q scan only and 22% single-photon emission computed tomography (SPECT).
For the magnetic resonance imaging (MRI) modalities, 51% of physicians reported access to pulmonary angiography and 30% to lung perfusion mapping. Thirty-nine (22%) physicians reported access to conventional pulmonary angiography or digital subtraction angiography.
Fifty-one percent of respondents reported a dedicated clinic for the follow-up of all PE patients (including low-risk, outpatientmanaged patients) and 14% ran a clinic for hospital-admitted patients only. The specialties involved in the follow-up service are shown in Figure 1. Of the 127 participants reporting a dedicated clinic, 87 (68.5%) had joint clinics, most commonly comprising either pulmonologists and
Figure 1. (a) Specialties involved in those centres that had dedicated clinics; (b) the composition of the clinics that involved multiple specialties
haematologists or pulmonologists, haematologists and cardiologists (with 16 participants reporting each; 18%). Additionally, 65% of physicians reported that their clinic had a specialist nurse (12% were not sure).
On average, the physicians’ centres saw 24 acute PE patients each month, with two-thirds receiving outpatient follow-up within 3–6 months (Figure 2). The patients treated by haematologists and pulmonologists were the most likely to receive a follow-up during this time frame.
Cardiology Special Focus: Pulmonary Embolism
Figure 2. Tests ranked in the order they would be used to investigate for CTEPD by physicians who routinely investigate for CTEPD following PE (N = 97). Red boxes indicate the most common ranking allocated to each investigation. 6MWD = 6 min walking distance; BNP = brain natriuretic peptide; CPET = cardiopulmonary exercise test; CTPA = computed tomography pulmonary angiogram; NT-proBNP = N-terminal pro-brain natriuretic peptide; Q = perfusion; V/Q = ventilation/perfusion.
The local guidelines for the followup of PE patients were followed by 63% of physicians, while 62% followed British Thoracic Society (BTS) guidance, 48% followed National Institute of Health and Care Excellence guidelines, 35% followed European Society of Cardiology (ESC) guidelines and 7% the American College of Chest Physicians guidelines.
Experience in Evaluating Suspected CTEPD
A diagnosis of CTEPD was routinely considered by 74% of the respondents following acute PE (84% cardiology, 88% respiratory, 72% haematology and 50% internal medicine) and routinely investigated for by 55% of the respondents. Notably, fewer haematologists would investigate patients with thrombophilias for CTEPD (8%) than other specialties (31–40%).
Echocardiogram was the test most often used to investigate for CTEPD, followed by computed tomography pulmonary angiogram (CTPA), while CPET was used the least often, although over half of the physicians reported using it. When asked to rank the tests in the order of use, physicians most often selected CTPA as the first-line test (58%), followed by echocardiogram (29%), 6-minute walking distance (6MWD) (5%) and V/Q scan (4%) (Figure 2).
All respondents were asked to rank the following from the most to least likely cause of persistent dyspnoea
in PE patients: CTEPD, CTEPH, lung disease, left heart disease, deconditioning and dysfunctional breathing/anxiety. The condition most often ranked first was CTEPH (32%), followed by lung disease (21%) and CTEPD (20%).
Most respondents (80%) reported knowing where their regional PH centre is located. The most common stage at which patients were typically referred to the PH service was at echocardiographic signs of PH or right heart dilatation, for most specialists. Notably, 42% of physicians, overall, said they would refer patients who were still symptomatic after 3 months of anticoagulation without conducting any further tests (42%), and 38% reported they would refer breathless patients even if tests were normal.
Overall, 31% of respondents always retrospectively review the CTPA from the initial PE assessment for signs of CTEPH, 42% sometimes, 19% occasionally and 9% never do, with pulmonologists being the most likely (84% always/ sometimes) to do so and internal medicine specialists the least likely (40% occasionally/never). Twentysix percent of respondents always or sometimes used a risk score calculator to estimate the CTEPH probability; however, 43% were unaware of such a tool. Similarly, 32% of physicians always or sometimes used a dyspnoea score, and 37% were unaware
of such a score. Most (82%) physicians did not use quality-oflife (QoL) questionnaires.
When asked to consider the patients at their centre with nonresolving breathlessness after 3 months of effective anticoagulation, 46% of physicians estimated that more than half of these patients underwent further tests to investigate for CTEPD . Overall, 28% of respondents were not sure how many PE patients at their centre typically develop CTEPH; 57% believed the incidence to be 0.6–5%.
Discussion
Most participants reported that their centre had local guidelines on PE management, but only half had a protocol for the investigation of CTEPD. Only 65% of physicians reported patients being followed up in a dedicated PE clinic, and only 22% reported that nonresolving breathlessness was investigated for CTEPD in >75% of cases. There was large variation in the follow-up of acute PE patients and in the awareness and approaches to the investigation of suspected CTEPD. The key takeaways are summarised in Box 1.
PE Management
It is encouraging that 89% of the respondents considered there to be local guidelines for PE follow-up. This is consistent with the results of the first BTS audit of the outpatient management of PE (audit period:
September and October 2021), which demonstrated that 80% of participating UK centres (n = 108) had a formalised outpatient PE pathway.17 Thirty-eight percent of respondents reported that their centre had a PERT; however, of these respondents, 47% were based in London and the term ‘PERT’ was not defined in our survey. Therefore, further study is needed to confirm how many centres have a PERT; studies should also investigate how these PERTs operate and which treatment options they have available.
Use of Imaging Modalities
All except two respondents (who were not sure) reported access to CT scans, and most had access to some form of nuclear imaging. Similarly, the BTS audit of outpatient PE management found that 92% of UK centres had 7-day access to CTPA, while 10% did not have access to nuclear imaging for patients unable to undergo CTPA.17
The ESC/European Respiratory Society (ERS) guidelines on PE and PH recommend the V/Q scan (or an alternative perfusion imaging modality) for first-line imaging in suspected CTEPH;1,2,8 however, 10% of respondents only had access to Q scan imaging, although the added value of ventilation imaging when other complementary imaging modalities are available is limited. There has been a gradual move toward the use of SPECT, as it is superior to planar V/Q imaging.16,18 In our
study, 22% of survey participants had access to SPECT. The survey results also show that CTPA and echocardiography were preferred over V/Q scanning as the first test to investigate for CTEPD (used first by 58%, 29% and 4% of physicians, respectively). The reasons for this were not captured, but it could be due to a greater availability of CT and echocardiography versus V/Q scans or the advantage of being able to look at the heart and lungs with CT imaging.18 Test suitability may also vary among patients; for example, a V/Q scan may be preferred for young female patients for whom exposure to CTPA radiation is a concern or in cases where the interpretation of the CTPA findings is difficult, such as for patients with a higher cardiac output or where there may be concerns regarding the ability of the patient to cooperate with the breath-holding requirements during the CT imaging. It should also be noted that 80% of physicians always or sometimes used lung function tests (80%) to investigate the possibility of CTEPD, despite these tests not being as discriminatory as the imaging tools. It is important to conduct appropriate tests, and this finding suggests there is room for improvement.
Access to other imaging modalities was higher than expected. This survey could have been completed by more than one respondent from the same centre, thereby falsely inflating these percentages; however, the distribution of respondents across the regions and specialties suggests that the level of this type of ‘duplication’ is not excessive.
Other Tools to Support Post-PE Follow-Up
The use of CTEPH risk scores varied across respondents; however, only one such tool has been validated.19 The In Shape II validation study of 424 patients found that the tool detected most (10 of 13) CTEPH patients within 4 months following PE.20 However, when applied to 2256 PE patients in the Computerized Registry of Patients with Venous Thromboembolism (RIETE), its sensitivity was found to be too low (27.3%) to rule out CTEPH.21 CTEPH risk score calculators may prove particularly useful when resources are limited, but they have some disadvantages. Because they are focused on distinguishing PH from non-PH, they do not help diagnose patients without PH. Also, completing the risk score before deciding on the next steps can require more visits
than simply booking a test and the subsequent follow-up appointment at the same visit.
In our study, 18% of physicians reported asking their patients to complete QoL questionnaires. The only validated PE-specific QoL tool22 was developed before quality standards for such instruments were devised and does not fully adhere to the guidelines.23 The low use reported in this survey is consistent with the authors’ observation that QoL questionnaires tend to be used in clinical trials rather than in clinical practice.
Aspects of Post-PE Follow-Up Needing Improvement
The BTS audit of outpatient PE management demonstrated that 87% of UK centres performed follow-up at 3 months, with this occurring in a dedicated PE clinic in 36% of the centres.17 In comparison, we found that 65% of the respondents’ centres had a dedicated PE clinic, but only 46% of the physicians reported that more than three-quarters of patients were offered a 3–6-month follow-up. A retrospective study of adults discharged from a UK teaching hospital with a diagnosis of acute PE in the first half of 2019 found that 31% of intermediate–high-risk and 37% of intermediate–low-risk patients were not followed up.24 The authors hypothesised that dedicated PE clinics with multidisciplinary team meetings could streamline post-PE follow-up and improve outcomes.24
The reasons for this gap in care are unknown; however, our finding that 74% of respondents routinely consider a diagnosis of CTEPD would suggest that lack of awareness is not predominant. Indeed, the high percentage of respondents rating CTEPD and CTEPH among the most common reasons for persistent symptoms following PE indicates that physicians are mindful of these conditions. Importantly, however, this finding reflects an inaccurate perception of the prevalence of CTEPD and CTEPH. Persistent dyspnoea and/ or poor physical performance are relatively common several months after acute PE, but most cases are attributable to muscle deconditioning (ranked as the most likely reason by only 18% of survey respondents).1,2 This finding could reflect that physicians’ answers are biased because they are aware the survey is related to CTEPD. The availability of the CT and V/Q scanning modalities reported by the respondents (99% and 90%, respectively) indicates
this is not a significant barrier to providing care.
The CLARITY survey found that the most frequent barriers affecting the detection of CTEPH after PE reported by respondents (353 physicians from Europe, Asia–Pacific and the Americas) were low disease awareness among nonexperts (77%), lack of structured follow-up after acute PE (56%), nonspecific presentation of disease (43%), incomplete understanding of the natural history of disease (39%) and lack of clinical guidelines to screen for possible CTEPH (73, 23%).25 Moreover, low adherence to guidelines was reported as a barrier to CTEPH diagnosis by approximately one-third of respondents.26 The variability in the physicians’ practices, as shown in this survey, could support this finding that more comprehensive guidelines on PE follow-up are needed.
Internal medicine specialists reported lower rates of follow-up with PE patients and consideration of CTEPD as a diagnosis. One of the BTS quality standards for the outpatient management of PE is that follow-up should be performed by a senior clinician with special interest in PE, as part of a formal pathway.31
Referral to PH Centre
Most respondents were aware of the location of their regional PH centre. There are seven adult specialist PH centres in the UK; three are in London and the others are in Newcastle, Glasgow, Cambridge and Sheffield. Hospital protocols should ensure smooth integration of their PE care pathways.
The survey pinpointed a specific practice that could be improved: 28% of physicians overall and 40% of internal medicine specialists occasionally or never review the CTPA from the initial PE assessment for signs of CTEPH. The In Shape III study showed that experts’ overall judgement on whether CTPAs at acute PE presentation showed signs of CTEPH achieved a sensitivity of 72% and a specificity of 94%.27 A subsequent study demonstrated that nonexpert readers could also accurately detect CTEPH based on specific radiological signs according to a scoring form.28 Therefore, routinely performing closer examination of initial CTPAs could improve detection of CTEPH.
Multidisciplinary Follow-Up of PE
In our survey, two-thirds of dedicated follow-up clinics were jointly run by more than one specialty. The benefits of such multidisciplinary clinics have been described previously.24 A clear pathway for the follow-up of patients presenting with PE who are already under other specialties and have risk factors for PE (e.g., oncology) will be important.29,30 In our study, the lower percentage of haematologists than other specialties routinely investigating for CTEPD in patients with thrombophilia likely reflects an understanding that investigations in these cases do not change disease management in many cases and suggests that the involvement of haematologists in clinic reviews could potentially avoid unnecessary investigations.
According to the ESC and ERS guidelines for the management of PE and PH, symptomatic patients with persistent mismatched perfusion defects 3 months following acute PE should be referred to a specialist centre after consideration of the results of echocardiography, brain natriuretic peptide (BNP)/Nterminal pro-brain natriuretic peptide (NT-proBNP) and/or CPET investigations.2,8 However, 42% of respondents in our survey reported that they typically referred (some) breathless patients without performing further tests, and 38% (sometimes) referred patients even if the subsequent test results were normal. A referral before conducting any further tests may be appropriate where there is a high index of suspicion based on original imaging, echocardiographic findings and medical history; however, in the majority of cases, patients would undergo further tests beforehand, as per guideline recommendations.1,2 In cases in which patients are referred even if tests are normal, access to V/Q scintigraphy may prevent unnecessary referrals or support referrals where appropriate.
Conclusions
Our survey results demonstrated a wide variation in clinical practice in the follow-up of patients presenting with acute PE and in the awareness and approaches to the investigation of suspected CTEPD. This could indicate that more comprehensive and structured guidelines for PE follow-up are needed. These data support the conduct of a national audit to improve our understanding of the barriers to the timely detection of CTEPD.
References available on request
Oral Contraceptives and Smoking impact Steroid Hormone Levels News
Steroid hormone levels are also influenced by other lifestyle choices and factors such as biological sex and age, according to new research that has just been published in leading international journal Science Advances.
The objective of the research was to expand knowledge and understanding of steroid hormone levels, including corticoids and sex hormones, in healthy women and men over a broad age range. This is the first study to analyse such a large number of hormones in nearly 1,000 healthy people, filling a major gap in the knowledge of molecules that are important for our day-to-day well-being.
The work was conducted by members of the Milieu Interieur consortium and led by Dr Darragh Duffy (Institut Pasteur) and Dr Molly Ingersoll (Institut Pasteur and Institut Cochin (Inserm U1016, CNRS, Université Paris Cité). Dr Jamie Sugrue, a Trinity College Dublin graduate, now a Marie Curie-funded postdoctoral researcher at the Institut Pasteur, is the co-first author. Dr Sugrue also worked with Trinity’s Professor Cliona O’Farrelly to secure a Research Ireland Ulysses grant, which kickstarted the ongoing collaboration between Trinity
Cliona O’Farrelly, Professor of Comparative Immunology in Trinity’s School of Biochemistry and Immunology
researchers and the Pasteur and Milieu Interieur consortium teams.
The team involved in this current study found that hormone levels vary according to an individual’s age and sex, but that they are also associated with many other factors, such as genetics and common behaviours.
Notably, many steroid hormone levels, beyond sex hormones, are influenced by oral contraceptive use in women, while in men, smoking was associated with altered levels of nearly every steroid hormone measured.
Additionally, measurement of hormones in the same donors 10 years after the original visit showed that decreases in specific androgens were associated with diverse diseases in aging men, implying that these hormones – which are associated with physical characteristics, and supporting strong bones and red blood cell production – play a role in disease development.
This finding – among others –gives the team numerous avenues to pursue in future research.
Dr Sugrue said, “Even in healthy people, immune responses can vary dramatically. As a first step towards understanding how hormones impact immunity, we worked to understand how hormones themselves vary among people. Our study provides a significant resource for the research community, and generates many new hypotheses for further research. Our next steps will focus
Bowel Cancer Screening
Ahead of Bowel Cancer Awareness Month (April), the HSE announced that from 1 April 2025, the eligible age range for BowelScreen is extending to include 70-year-olds. Free bowel screening is now available to everyone aged 59 to 70.
BowelScreen invites eligible people to take part every two years using a simple FIT kit test sent to your home. The instructions are easy to follow and it’s done in the privacy of your own
bathroom. Using the kit, you take a sample of your poo and post it back to BowelScreen in a plain freepost envelope. The test looks for a level of blood in your poo. The results will be sent out to you within four weeks.
Professor Padraic MacMathuna, Clinical Director of BowelScreen, said, “BowelScreen is a valuable health check that can prevent cancer developing and save lives by finding cancer early. For most people, the FIT kit will be the
on understanding how variation in hormone levels contribute to differences in the immune response between people.”
“My current project is specifically focused on variation in antiviral immune responses in healthy people, and in many ways is a continuation of work that I started during my PhD with Prof. Cliona O'Farrelly at Trinity, where we worked on how antiviral immune system variation can confer resistance to hepatitis C virus infection. By incorporating the hormone measures into my current analysis I hope to uncover exciting new insights.”
Cliona O’Farrelly, Professor of Comparative Immunology in Trinity’s School of Biochemistry and Immunology, added, “If the COVID pandemic taught us anything it was how different all our immune systems are, and being part of the Milieu Interieur collaboration is giving us Trinity researchers a wonderful opportunity to study the molecular and genetic mechanisms
responsible for these differences at scale.”
Co-first author, Dr Léa G Deltourbe, Institut Pasteur & Institut Cochin,added, “This study brings much needed data to a subject that is receiving a lot of interest in the mainstream news and on social media platforms, providing a strong basis for investigating the role of steroid hormones in health and disease, including the impact of endocrine disruptors, the link between stress and cortisol, and the role of sex hormones on our well-being.”
As one example, understanding the potential effects of the contraceptive pill on physical and mental health should lead to a better quality of life for women choosing to use this form of medication.
The exciting results in this paper were first presented to an international audience at the Sex Differences in Immune Health conference recently hosted by Trinity.
PMI Stakeholder Briefing
The Pharmaceutical Manufacturers’ Institute will host Prof Michael Barry, Clinical Director with the NCPE for a breakfast briefing on May 22nd. During his talk, Prof Barry will discuss Healthcare Cost Effectiveness and will give an outline of the trends and observations in reimbursement across the industry along with policy updates from the NCPE. Visit www.thepmi.com for more information.
only test needed. About 3%* of people who do the BowelScreen test are referred for a follow-up colonoscopy.
“This is where we look for and remove pre-cancerous changes, called polyps, from the lining of the bowel. We know that most bowel cancers develop from polyps so by doing this we can prevent cancer.
“Bowel screening is an important part of your normal healthcare routine, but it won’t find all changes.
“Cancer can develop at any time. If you are experiencing symptoms, including changes in your bowel habits, unexplained weight loss or blood in your poo then you should see a GP, even if you have recently had screening or you’re due to take your next screening test. Don’t wait for screening, see your GP if you have symptoms.”
For more information, visit hse.ie/bowelscreen.
Ireland’s First Patient Stem Cell Research Facility
Pictured (l-r): Professor Killian Hurley, Associate Professor of Medicine at RCSI and Consultant in Respiratory Medicine at Beaumont Hospital; David Crosby, a double lung transplant recipient and advocate for the new facility; Anne Coyle, CEO of Beaumont Hospital; and Dr Seamus Browne, Head of Strategic Research Initiatives and Industry Partnerships
Ireland’s first dedicated patient stem cell research facility has been opened by RCSI University of Medicine and Health Sciences. The RCSI Patient Stem Cell Discovery Core is a state-ofthe-art research lab that will accelerate innovation in stem cell science and play a vital role in advancing personalised and precision medicine.
Located at RCSI’s Smurfit Education and Research Centre at Beaumont Hospital, the new facility marks a significant milestone in patient-centered biomedical research in Ireland. It will enable advanced stem cell research and personalised drug testing, with initial applications focusing on lung disease and extending to other conditions over time.
A unique facility in Ireland, the RCSI Patient Stem Cell Discovery Core is fully integrated within both Beaumont Hospital’s clinical services and RCSI’s research ecosystem. Patient samples can be brought directly from the hospital to the research lab just a short walk away, enabling clinically informed and comprehensive testing of personalised treatments. The vision of this facility is that the proximity of the hospital will mean that the impact of discoveries can be felt more quickly, with insights generated in the lab directly informing patient care back in the hospital. This closed loop of research and treatment is particularly valuable in diseases
like pulmonary fibrosis, where precise and tailored interventions are essential.
The facility will also support gene editing to advance novel therapeutic strategies and partnerships with industry and academic institutions to create a collaborative hub for discovery.
Professor Killian Hurley, Associate Professor of Medicine at RCSI and Consultant in Respiratory Medicine at Beaumont Hospital, emphasised its transformative potential: “Through this unique national resource, we can now test new drugs on patient-specific cells grown in the lab. This will enable clinicians to better predict treatment responses and translate this into patient care, particularly in complex lung diseases where a personalised approach is essential. It is a major step forward in our ability to tailor treatments to the individual.”
David Crosby, a double lung transplant recipient, has been a passionate supporter of the new facility and helped raise funds to make it a reality: “As someone living with pulmonary fibrosis and the recipient of a double lung transplant, I know how critical it is to have access to treatments that are tailored to each patient’s condition. This facility will help make treatments more personalised and evidence-based not just for me but for many others living with complex conditions. I’m proud to have supported something that puts patients at the heart of discovery and care.”
The launch of the RCSI Patient Stem Cell Discovery Core reinforces RCSI’s role as a national and international leader in translational medicine, placing patient outcomes at the centre of research.
Reducing the Risk of Skin Cancer
The ISF, in collaboration with the HSE’s National Cancer Control Programme (NCCP) and the National Cancer Registry of Ireland (NCRI) recently launched an updated ‘Reduce your risk of Melanoma Skin Cancer (Holidaying at home or abroad)’ Infographic, targeting the sun-loving public but with a particular focus on those who intend to spend time
holidaying in the sun, whether at home or abroad.
The main aim is to raise awareness of the link between personal susceptibility (i.e. skin type), lifestyle behaviours (i.e. sunny holidays frequently associated with sunburn) and the pattern and timing of UV exposure (i.e. occasional, intense sun exposure
and sunburn increases melanoma risk, particularly during childhood).
The infographic was first published in 2017 to illustrate the steep rise in incidence of melanoma skin cancer, the risks associated with intermittent, intense UV exposure and sunburn, and how to reduce your risk. It was updated in 2019, and again in 2024 to highlight the upward trend in melanoma incidence and reinforce the
Professor Fergal O’Brien, Deputy Vice Chancellor for Research and Innovation at RCSI, said: “We are proud to lead the way with Ireland’s first fully clinically integrated patient stem cell research lab. By enabling our researchers and collaborators to develop stem-cell-based models of disease, we’re accelerating the translation of laboratory discoveries into treatments. This is a true bench-to-bedside resource, advancing precision medicine that is tailored to the individual needs of patients.”
The RCSI Patient Stem Cell Discovery Core is co-funded by RCSI and the generous support from patient advocates. Future work in the facility will be supported by funding from Research Ireland, the Health Research Board, and the European Research Council.
SunSmart messaging in the National Skin Cancer Prevention Plans 2019-2022 and 2023-2026. This resource is available to download from the ISF’s dedicated SunSmart webpage http://www. irishskin.ie/sunsmart , the HSE NCCP’s SunSmart campaign resources for professionals www.hse.ie/skincancerprevention and the NCRI www.ncri.ie
Post-Herpetic Neuralgia
Post-Herpetic Neuralgia: Diagnosis and Management Options
Herpes zoster is a relatively common disease; the estimated incidence of acute herpes infection in the European population varies from 1.2 to 5.2 per 1000 people per year. There is a correlation between the incidence of the disease and age. People younger than 50 years have a low risk of developing herpes zoster which equals approximately 2%. The incidence sharply rises in adults above 50 years; the risk makes up to at least 20% and continues to increase further reaching 35% in people above 80 years [1]. The recent upswing in chickenpox infection and varicella-zoster virus (HZ) in the community has increased the risk of developing post-herpetic neuralgia (PHN).
PHN is an extremely painful condition, that can persist for many years making life miserable for the unfortunate patient. Early recognition is very important and can offset chronicity. For those who are not so lucky there are advanced options to help manage the pain.
Epidemiology
In the acute phase of inflammation, the virus reaches the sensory nervous system and remains latent in trigeminal or dorsal root ganglions for a long period of time. Reactivation of the HZ happens with advancing age or immunosuppression can lead to the development of acute herpes zoster. Postherpetic neuralgia occurs in a subset of the population suffering from an episode of acute HZ. Wellestablished risk factors for an acute HZ episode progressing to PHN include age, severe
Written by Professor Dominic A. Hegarty, BSc., BMedSc., MB., MSc. (Pain Management), PhD. FCARSCI, FFPMCAI, FIPP
Consultant in Pain Management & Neuromodulation and Clinical Director Mater Private Hospital, Cork
Associate Professor of Pain Medicine, UCC, Ireland
Honorary Consultant Guy's & St. Thomas' Hospital, London
President World Institute Of Pain (WIP)
Clinical Director Pain Relief Ireland www.painreliefireland.ie
immunosuppression, the presence of a prodromal phase, severe pain during zoster outbreak, allodynia, ophthalmic involvement, and diabetes mellitus.
A meta-analysis of the risk factors for the development of PHN published in 2016 noted that approximately 13% of patients older than or equal to 50 years of age with HZ would develop PHN. The association between increasing age and PHN is significant. According to some studies, at age 60, around 60% of patients with shingles develop postherpetic neuralgia, and at age 70, this percentage rises to 75%.
One month after the onset of shingles, 9 to 14.3% of patients develop postherpetic neuralgia, and at three months, this percentage becomes 5%. At one year, 3% of patients continue to have severe pain.
Family history has also been considered a risk factor for herpes zoster. In a case-control study by Hicks et al., comprising 504 patients and 523 controls, it was observed that the blood relatives of patients were more likely to have herpes zoster than the control group (39% vs. 11%, p< .001). Moreover, this risk was more significant in patients with multiple blood relatives having herpes zoster than those with a single blood relative having herpes zoster. There is no sex predilection for postherpetic neuralgia.
COVID 19 and PHN.
In a retrospective cohort study of over 2 million people it was highlighted that adults over 50 years of age who had mild COVID-19 are 15% more likely to develop HZ within 6 months compared to those who have not been infected by coronavirus. The risk was 21% greater in older people who were hospitalized by with COVID19. (Bhavsar et al. Open forum Infectious Diseases).
Predictors
The predictors of PHN development include advanced age, acute pain, severe rash, prodromal pain, presence of the virus in peripheral blood, and adverse psychosocial factors. The associated pain with concomitant allodynia is traditionally attributed to the decrease in the activation threshold of pain-associated neuron clusters. Recently some researchers have shown that TRVP1 receptor activation may also be implicated. This receptor may be a promising target for future analgesic drug development.
Pathophysiology
The exact physiology that separates a self-limited zoster outbreak from postherpetic neuralgia is not fully understood. Histological examinations of relevant peripheral and central nervous tissue from sufferers of PHN reveal myelin and axon deficiency and atrophy of the dorsal horn in certain instances. One study compared the difference in epidermal axon densities between patients who suffered from PHN and those who had a self-limited occurrence
of HZ. Those afflicted with PHN had, in most instances, far fewer axons in the relevant dermatomes than non-sufferers. Therefore, an anatomical derangement is likely at least partially responsible for the development of PHN. Some suggest that an unchecked inflammatory response at the neuronal level is the main culprit of the eventual development of PHN, specifically via the reduction of centrally-mediated inhibition of nociceptive input and the promotion of peripheral sensitization via damaged nociceptors.
The DRG suffers the most damage during PHN. Firstly, the reactivated varicella-zoster virus in the DRG proliferates and destroys axons, causing demyelination and ion channel dysfunction. The damaged sensory nerves can generate abnormal electrical impulses that are transmitted to the spinal cord transmitting pain and pain hypersensitivity. A significant number of inflammatory cells are shown to invading into DRG of patients with PHN. Then, the inflammatory mediators that follow promote increase pain pathway activity and causes central sensitization.
Diagnosis
The diagnosis of postherpetic neuralgia is relatively straightforward and not one of exclusion. An episode of herpes zoster is a prerequisite for PHN. Therefore, a history of rash with blisters in a dermatomal pattern would be expected. Rarely the characteristic rash will not be found. Persistent (more than or equal to 3 months)
Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. [PubMed: 25317872]
Figure 1 Herpes Zoster acute blister formation
Figure 1 Herpes Zoster acute blister formation
lancinating/burning pain, allodynia, paraesthesia’s, pruritus, dysesthesias, and/or hyperalgesia at or near the area of the rash is characteristic of PHN.
Herpes zoster can reactivate sub clinically with no rash. This condition is called zoster sine herpete and is more complicated. It affects the central nervous system at multiple levels and causes cranial neuropathies, myelitis, polyneuritis, or aseptic meningitis.
Physical examination of a patient with postherpetic neuralgia may reveal the following:
• Evidence of cutaneous scarring on an area of previous herpes zoster
• Altered sensation in the affected areas, either hypersensitivity or hypoesthesia
• Pain is produced by nonnoxious stimuli, such as a light touch, known as allodynia
• Autonomic dysfunction, such as excessive sweating over the involved area
Investigations
Postherpetic neuralgia is almost universally diagnosed based on the history and physical examination. However, laboratory tests and some targeted imaging may provide a degree of utility. These are of greater value in atypical presentations of PHN, such as zoster sine herpete or herpes zoster of the larynx. Serological testing for VZV IgG and IgM titers is possible, although the sensitivity and specificity are less than ideal. A four-fold rise has been used to diagnose subclinical HZ (zoster sine herpete). However, this rising titer may or may not be secondary to viral exposure or reactivation. Comparatively, immunofluorescence of vesicle scrapings detects VZV antigens in a highly specific and sensitive manner. Similarly, PCR is exquisitely sensitive for the detection of VZV DNA.
Results of cerebrospinal fluid (CSF) analysis are abnormal in 61% of patients. Pleocytosis, elevated protein, and varicella-zoster virus (VZV) DNA are usually seen. Viral culture or immunofluorescent staining helps distinguish herpes simplex from herpes zoster.
Small-scale studies suggest that magnetic resonance imaging (MRI) may hold promise for diagnosing challenging PHN cases and differentiating between PHN and HZ. A study by Haanpaa et al. reported that MRI revealed lesions attributable to HZ in the cervical cord and the brain stem in 9 patients (56%). At three months after the onset of HZ, PHN
2) Early Recognition. Early recognition and treatment of an acute HZ infection, may reduce the chance developing PHN. The benefit of rapid treatment has been shown to be very useful. If a combination agents can be commenced with 72 hours of first symptoms this will lower the chance of compilations
developed in 5 patients (56%) who had an abnormal MRI. On MRI, seven patients with no HZ lesions did not develop residual pain.
Management Options
Three fundamental treatment approaches may be considered for postherpetic neuralgia.
1) Prevention. This focuses on identifying populations at risk for contracting HZ and administering a vaccine. At present there are two licenced HZ vaccines in Ireland ( MIMS May 2023) – Shingrix and Zostavax. This should be considered in those over 50 years and in those in the higher risk groups. It is not necessary to determine whether patients have a history of varicella or zoster prior to vaccination because weaning antibodies in those previously exposed may lead to negative results despite past infection A large (n = 38,000) double-blind study published in the NEJM in 2005 showed that vaccination in the elderly reduced the incidence of HZ by 51% and PHN by 66%. Moreover, even among those who developed PHN, the burden of illness was reduced by approximately 61%. It must be noted that the immune-boosting effect of the vaccination is not long-lasting, and interval re-vaccination is necessary to maintain its efficacy.
Table 1 Suggested Agents to consider in the early management plan Antivirals
Simple Analgesics
Neuropathic Pain Management
Topical
• Acyclovir (Sitavig, Zovirax)
• Famciclovir (Famvir)
• Valacyclovir (Valtrex)
• Acetaminophen
• Ibuprofen
• Naproxen
• Pregabalin
• Gabapentin
• Amitriptyline
• Lidocaine patches
• Capsaicin cream
• Ice packs
3) PHN management
c) Lidocaine Patches
In the situation where PHN develops the symptom management of PHN is best considered using multimodal medication regimens and interventional procedures. The evidence regarding the efficacy of these methods mixed but rapidly evolving, and certain approaches appear to be more successful than others.
Unfortunately, these vaccines are not part of the national immunisation program so patients need to discuss this option with their GP and selffund the vaccine.
increases the risk side effect profiles of interventions. Relevant studies comparing treatments and their outcomes are often suboptimal designed. There is no one superior treatment regimen; however, expert consensus suggests that multimodal therapy is likely the best approach. Lastly, many of the advocated approaches treat chronic neuropathic pain in general and are not specific to PHN.
Multiple studies have confirmed the short and long-term efficacy of the lidocaine 5% patch. This patch also has the additional benefit of a small side effect profile that is mostly limited to application site reactions. Application is required for 12 hours at a time and should be used over prolonged period (4-8 weeks initially)
Complete resolution of the symptoms is rare. A 2014 study concluded that less than half of patients with PHN achieve significant symptom reduction. The age of the patient population increases the risk side effect profiles interventions. Relevant studies comparing treatments and their outcomes are often suboptimal designed.
d) Capsaicin
2) Early Recognition. Early recognition and treatment of an acute HZ infection, may reduce the chance of developing PHN. The benefit of rapid treatment has been shown to be very useful. If a combination of agents can be commenced with 72 hours of first symptoms this will lower the chance of compilations
3) PHN management
In the situation where PHN develops the symptom management of PHN is best considered using multimodal medication regimens and interventional procedures. The evidence regarding the efficacy of these methods is mixed but rapidly evolving, and certain approaches appear to be more successful than others.
Complete resolution of the symptoms is rare. A 2014 study concluded that less than half of patients with PHN achieve significant symptom reduction. The age of the patient population
a) Traditional non-invasive treatments include oral and topical medications. The American Academy of Neurology (AAN), Special Interest Group on Neuropathic Pain (NeuPSIG), and European Federation of Neurological Societies (EFNS) all recommend an oral tricyclic antidepressant (TCA), pregabalin, and the lidocaine 5% patch as first-line therapies. The anticholinergic, antihistaminergic, and alpha receptor-blocking side effects of TCAs must be considered, as the elderly are more susceptible. As a result, it is commonplace to initially prescribe and titrate a gabapentinoid, keeping in mind that patients with reduced renal function should be started at a lower dose and up-titrated more slowly.
There is no one superior treatment regimen; however, expert consensus suggests that multimodal therapy is likely the best approach. Lastly, many of the advocated approaches treat chronic neuropathic pain in general and are specific to PHN.
a) Traditional non-invasive treatments include oral and topical medications. The American Academy Neurology (AAN), Special Interest Group on Neuropathic Pain (NeuPSIG), and European Federation Neurological Societies (EFNS) all recommend an oral tricyclic antidepressant (TCA), pregabalin, and the lidocaine 5% patch as first-line therapies The anticholinergic, antihistaminergic, and alpha receptor
b) The use of opioids to combat PHN is controversial because of the changing landscape regarding what constitutes appropriate use and also renewed governmental interest in their administration given the epidemic of abuse, addiction, and mortality. The above three medical societies recommend opioids as either first or second-line treatments, which underscores the painreducing capability of this medication class.
Capsaicin preparations in the patch and cream formulations are also available but not as well-studied as the lidocaine patch. The leading cause of discontinuing capsaicin treatment is pain and irritation at the application site, suffered by almost all users in proportion to the capsaicin concentration. The cream has a low concentration of capsaicin, requiring multiple applications to achieve a therapeutic effect throughout the day. Conversely, the capsaicin patch is available in an 8% formulation, delivering a therapeutic dose in just one application. The higher concentration patch should only be provided by those trained in the application and monitoring of outcome. Nevertheless, encouraging case reports and other literature suggest the intervention warrants consideration and further study.
e) Non-TCA antidepressants and NMDA antagonists.
There is limited evidence to supports their usefulness. For example, larger studies involving SNRIs (serotonin-norepinephrine reuptake inhibitors) and SSRIs (selective serotonin reuptake inhibitors) have not shown better outcomes than TCAs, and both classes possess concerning side effect profile, though
typically less severe than TCAs. The use of ketamine infusion and related studies for treating a wide range of ailments, from neuropathic pain to depression, has also resulted in renewed interest in the role of NMDA antagonism in treating PHN. There are anecdotal reports that ketamine may prove beneficial, and a few small studies support this finding, but long-term data and large-scale studies are non-existent. Lidocaine
infusions have also been considered. One double-blind study in 1999 showed that an intravenous lidocaine infusion provided clinically significant short-term pain reduction in patients with PHN. In general, small studies and case reports have established that novel therapies may be useful in certain PHN sufferers when combined with other adjuncts. The pathophysiology of PHN is complex, and sometimes an
individualized non-traditional approach may prove beneficial for a particular patient.
f) Invasive Therapies.
Often when an individual presents to a chronic pain clinic they will have tried a number agents so interventional options need to be considered. If the pain persists in a specific dermatomal or nerve distribution then a simple effective option is to use a peripheral nerve
block or pulsed denervation the dorsal root ganglion Pulsed radiofrequency (PRF) is a minimally invasive technique that applies pulsed current (300–500 kHz) to the target nerve. The current is delivered in a pulse of 20 ms (45 V’ voltage) followed by a silent period of 480 ms to avoid heat lesions. Recent studies have confirmed the beneficial effects of PRF against post-operative pain, peripheral neuropathic pain, and postherpetic neuralgia. The thoracic nerves (T1-12) are the most commonly affected by PHN with an incidence of up to 50% cases. Studies have shown that both DRG and intercoastal nerve treated with PRF treatments are effective in the treatment of thoracic postherpetic neuralgia. Targeting the dorsal root ganglion gas shown to have a better outcome in pain intensity and other quality of life domains (SF-36).
Other invasive therapies include botulinum toxin injections, sympathetic blockade with local anaesthetics, and epidural/ intrathecal injections have a limited side effect profile. However, more studies need to be conducted to evaluate their efficacy. The other invasive therapies mentioned carry the potential for significant peri-procedural risk and/or side effects.
g) Future therapy options
Neuromodulation offers the possibility of long-term drug-free pain therapy inn a wide range of neuropathic pain conditions.
Figure 2 Viral load in effected nerve fibers
The development of the dorsal root ganglion stimulator to treat focal dermatomal neuropathic pain conditions is theoretically promising for PHN. Traditional spinal cord stimulation programming option can now target painful area with greater accuracy. We need to extend studies to consider the role of technology to advance our options.
Long-term Enhancement of Healthcare Team Outcomes
Considering that postherpetic neuralgia is difficult to treat and outcomes are variable, prevention is of paramount importance. Therefore, primary care physicians and geriatricians are tasked with administering vaccinations to at-risk populations. The ever growing aging population means that demands on this service will continue to increase. Inclusion of the vaccines on the national immunisation program by the Department of Health needs to be considered as a priority if we are to protect our venerable senior citizens. When preventative measures fail or are never instituted, experts in the field of pain management who have experience with the condition and multimodal treatment techniques should be consulted. Interventional pain management can offer solutions. An interprofessional approach to managing patients with postherpetic neuralgia is the best way forward.
References
Isagulyan E, Tkachenko V et al. The Effectiveness of Various Types of Electrical Stimulation of the Spinal Cord for Chronic Pain in Patients with Postherpetic Neuralgia: A Literature Review; Pain Research and Management Volume 2023, Article ID 6015680, 8 pages
Huang et al. Efficacy and safety of pulsed radiofrequency modulation of thoracic dorsal root ganglion or intercostal nerve on postherpetic neuralgia in aged patients: a retrospective study BMC Neurol (2021) 21:233 https://doi. org/10.1186/s12883-021-02286-6
Forstenpointner J, Rice ASC, Finnerup NB, Baron R. Update on Clinical Management of Postherpetic Neuralgia and Mechanism-Based Treatment: New Options in Therapy. J Infect Dis. 2018 Sep 22;218(suppl_2):S120-S126. [PubMed: 30247597]
Lu WH, Lin CW, Wang CY, Chen LK, Hsiao FY. Epidemiology and long-term disease burden of herpes zoster and postherpetic neuralgia in Taiwan: a populationbased, propensity score-matched
cohort study. BMC Public Health. 2018 Mar 20;18(1):369. [PMC free article: PMC5859733] [PubMed: 29554872]
Gabutti G, Valente N, Kuhdari P, Lupi S, Stefanati A. Prevention of herpes zoster and its complications: from the clinic to the real-life experience with the vaccine. J Med Microbiol. 2016 Dec;65(12):1363-1369. [PubMed: 27902409]
Zorzoli E, Pica F, Masetti G, Franco E, Volpi A, Gabutti G. Herpes zoster in frail elderly patients: prevalence, impact, management, and preventive strategies. Aging Clin Exp Res. 2018 Jul;30(7):693702. [PubMed: 29721782]
Schutzer-Weissmann J, FarquharSmith P. Post-herpetic neuralgia - a review of current management and future directions. Expert Opin Pharmacother. 2017 Nov;18(16):1739-1750. [PubMed: 29025327]
Delaney A, Colvin LA, Fallon MT, Dalziel RG, Mitchell R, FleetwoodWalker SM. Postherpetic neuralgia: from preclinical models to the clinic. Neurotherapeutics. 2009 Oct;6(4):630-7. [PMC free article: PMC5084285] [PubMed: 19789068]
Hicks LD, Cook-Norris RH, Mendoza N, Madkan V, Arora A, Tyring SK. Family history as a risk factor for herpes zoster: a case-control study. Arch Dermatol. 2008 May;144(5):603-8. [PubMed: 18490586]
Helgason S, Petursson G, Gudmundsson S, Sigurdsson JA. Prevalence of postherpetic neuralgia after a first episode of herpes zoster: prospective study with long term follow up. BMJ. 2000 Sep 30;321(7264):794-6. [PMC free article: PMC27491] [PubMed: 11009518]
Chen F, Chen F, Shang Z, Shui Y, Wu G, Liu C, Lin Z, Lin Y, Yu L, Kang D, Tao W, Li Y. White matter microstructure degenerates in patients with postherpetic neuralgia. Neurosci Lett. 2017 Aug 24;656:152-157. [PubMed: 28729077]
Watson CPN, Deck JH, Morshead C, Van der Kooy D, Evans RJ. Post-herpetic neuralgia: further post-mortem studies of cases with and without pain. Pain. 1991 Feb;44(2):105-117. [PubMed: 1711192]
Werner RN, Nikkels AF, Marinovic B, Schäfer M, Czarnecka-Operacz M, Agius AM, Bata-Csörgo Z, Breuer J, Girolomoni G, Gross GE, Langan S, Lapid-Gortzak R, Lesser TH, Pleyer U, Sellner J, Verjans GM, Wutzler P, Dressler C, Erdmann R, Rosumeck S, Nast A. European consensus-based (S2k)
Guideline on the Management of Herpes Zoster - guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV), Part 1: Diagnosis. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):9-19. [PubMed: 27804172]
Koshy E, Mengting L, Kumar H, Jianbo W. Epidemiology, treatment and prevention of herpes zoster: A comprehensive review. Indian J Dermatol Venereol Leprol. 2018 May-Jun;84(3):251-262. [PubMed: 29516900]
Spiegel R, Miron D, Lumelsky D, Horovitz Y. Severe meningoencephalitis due to late reactivation of Varicella-Zoster virus in an immunocompetent child. J Child Neurol. 2010 Jan;25(1):87-90. [PubMed: 19494359]
Harbecke R, Oxman MN, Arnold BA, Ip C, Johnson GR, Levin MJ, Gelb LD, Schmader KE, Straus SE, Wang H, Wright PF, Pachucki CT, Gershon AA, Arbeit RD, Davis LE, Simberkoff MS, Weinberg A, Williams HM, Cheney C, Petrukhin L, Abraham KG, Shaw A, Manoff S, Antonello JM, Green T, Wang Y, Tan C, Keller PM., Shingles Prevention Study Group. A real-time PCR assay to identify and discriminate among wild-type and vaccine strains of varicella-zoster virus and herpes simplex virus in clinical specimens, and comparison with the clinical diagnoses. J Med Virol. 2009 Jul;81(7):1310-22. [PMC free article: PMC4217208] [PubMed: 19475609]
Haanpää M, Dastidar P, Weinberg A, Levin M, Miettinen A, Lapinlampi A, Laippala P, Nurmikko T. CSF and MRI findings in patients with acute herpes zoster. Neurology. 1998 Nov;51(5):1405-11. [PubMed: 9818869]
Lang PO, Ferahta N. [Recommendations for treatment and prevention of herpes zoster and associated pain in aged adults]. Rev Med Interne. 2016 Jan;37(1):35-42. [PubMed: 26383768]
Kim SR, Khan F, Ramirez-Fort MK, Downing C, Tyring SK. Varicella zoster: an update on current treatment options and future perspectives. Expert Opin Pharmacother. 2014 Jan;15(1):6171. [PubMed: 24289750]
Argoff CE. Review of current guidelines on the care of postherpetic neuralgia. Postgrad Med. 2011 Sep;123(5):134-42. [PubMed: 21904096]
Raja SN, Haythornthwaite JA, Pappagallo M, Clark MR, Travison TG, Sabeen S, Royall RM, Max MB. Opioids versus antidepressants in postherpetic neuralgia: a randomized, placebocontrolled trial. Neurology. 2002 Oct 08;59(7):1015-21. [PubMed: 12370455]
Shrestha M, Chen A. Modalities in managing postherpetic neuralgia. Korean J Pain. 2018 Oct;31(4):235-243. [PMC free article: PMC6177534] [PubMed: 30310548]
Baron R, Allegri M, Correa-Illanes G, Hans G, Serpell M, Mick G, Mayoral V. The 5% LidocaineMedicated Plaster: Its Inclusion in International Treatment Guidelines for Treating Localized Neuropathic Pain, and Clinical Evidence Supporting its Use. Pain Ther. 2016 Dec;5(2):149-169. [PMC free article: PMC5130910] [PubMed: 27822619]
Derry S, Rice AS, Cole P, Tan T, Moore RA. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017 Jan 13;1(1):CD007393. [PMC free article: PMC6464756] [PubMed: 28085183]
Goncalves D, Rebelo V, Barbosa P, Gomes A. 8% Capsaicin Patch in Treatment of Peripheral Neuropathic Pain. Pain Physician. 2020 Sep;23(5):E541-E548. [PubMed: 32967405]
Kim YH, Lee PB, Oh TK. Is magnesium sulfate effective for pain in chronic postherpetic neuralgia patients comparing with ketamine infusion therapy? J Clin Anesth. 2015 Jun;27(4):296-300. [PubMed: 25792176]
Baranowski AP, De Courcey J, Bonello E. A trial of intravenous lidocaine on the pain and allodynia of postherpetic neuralgia. J Pain Symptom Manage. 1999 Jun;17(6):429-33. [PubMed: 10388248]
Apalla Z, Sotiriou E, Lallas A, Lazaridou E, Ioannides D. Botulinum toxin A in postherpetic neuralgia: a parallel, randomized, double-blind, single-dose, placebo-controlled trial. Clin J Pain. 2013 Oct;29(10):857-64. [PubMed: 23370074]
Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. [PubMed: 25317872]
Beyond the Scope: Advancing IBD Diagnosis and Management with Bedside Ultrasound
Written by Dr Ella Patchett and Dr Karl Hazel - Department of Gastroenterology, Connolly Hospital Blanchardstown
Introduction
Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel conditions characterised by periods of relapsing and remitting disease and progressive bowel damage. The complexity of IBD management and diagnosis lies in its heterogeneous presentation, unpredictable disease course, and the need for lifelong monitoring to prevent complications such as strictures, fistulas, and colorectal cancer.
The aims in management of inflammatory bowel disease include amelioration of patients’ symptoms, to promote endoscopic and histological remission in order to support long-term clinical remission and avoidance of IBD complications.1 Traditionally, this was achieved through regular surveillance endoscopy; the gold standard for assessing mucosal inflammation and guiding therapeutic decisions. Colonoscopy allows for direct visualisation of the intestinal mucosa, enabling biopsies for histopathological evaluation, which remains essential for confirming disease activity and dysplasia surveillance.2 However, it is not without its drawbacks. Endoscopy is an invasive, time-consuming, and costly procedure and creates a burden
on ever-growing Irish waiting lists. It may also be associated with lower patient tolerability, anxiety and discomfort.3 In addition to colonoscopy, crosssectional imaging modalities such as magnetic resonance enterography (MRE) and computed tomography (CT) are frequently employed to assess disease extent, complications, and extramural involvement. While these imaging techniques provide crucial insights, they can also be expensive, time-consuming, and, in the case of CT, expose patients to ionizing radiation.4
In recent years, intestinal or bowel ultrasound (IUS) has emerged as a valuable, non-invasive tool for evaluating IBD. Intestinal ultrasound utilises high-frequency sound waves to generate realtime images of the bowel wall and surrounding structures.5 IUS visualises all bowel wall layers (mucosa, submucosa, muscularis propria, serosa), enabling assessment of transmural inflammation, a hallmark of CD.
Unlike endoscopic procedures, IUS is non-invasive, requires no bowel preparation or sedation, and can be performed at the bedside. Key parameters assessed during IUS include:6
- Bowel Wall Thickness (BWT): Increased thickness (>3 mm
in the small bowel and right colon, >4 mm in the left colon) often correlates with active inflammation
- Bowel Wall Hyperaemia using doppler ultrasound: marker of active inflammation
- Wall Stratification: Loss of the normal five-layer bowel wall structure suggests severe inflammation or fibrosis
- Surrounding lymphadenopathy and free fluid: can indicate more severe disease
- Complications associated with IBD: strictures, abscesses and fistula
Unlike colonoscopy, which primarily evaluates mucosal disease, IUS provides additional information on transmural inflammation and extramural complications, making it a complementary modality rather than a replacement.5 The integration of IUS into routine clinical practice has the potential to enhance patient care by providing immediate insights during consultations, thereby supporting a treat-to-target approach in IBD management.
Global Use
Numerous studies internationally, particularly those performed in the US and central Europe, have shown promising results for the introduction of IUS as a standard of care for IBD. The TRUST study was a large multicentre project conducted in over 45 German hospitals which found that IUS can be used to effectively monitor treatment response in patients with active CD.8
Whilst information can be extrapolated from these studies, it is potentially more useful to look at similar studies performed in the UK – slightly closer to home with similar patient cohorts and demographics to an Irish population. Literature of note includes the 2018 METRIC trial.17 In a cohort of 284 patients, the authors conclude both MRE and ultrasound have high sensitivity for detecting the presence of
small bowel disease and both are valid first-line investigations in the assessment of IBD. In a further UK study in 2022, 260 patients were investigated via colonoscopy or MRE to assess lower gastrointestinal symptoms, IBD severity or clinical response to treatment.7 Patients were classified into either IUS-suitable or nonsuitable based on clinical factors e.g. IBD patients without dysplasia surveillance or stricture dilatation. This study determined that 28% of endoscopy patients and 55% of MRE patients were deemed IUS suitable. The primary objective of this work was to assess the cost analysis of introducing IUS as a replacement for endoscopy/MRE for those deemed suitable. They concluded that a projected annual saving of £500,000 could be achieved with the implementation of a IUS integrated programme.
IUS in Ireland
Transabdominal ultrasound has been used as a modality for assessing IBD in central Europe; namely Germany and Italy for the preceding decades but has recently been utilised more in other European countries, Canada and the US via a centralised training programmed through the International Bowel Ultrasound Group (IBUS).8 The use of IUS in Ireland has gained acceptance and is now utilised across a small number of sites and will likely have a significant and positive impact on the future management of IBD and other lower GI conditions.9
Firstly, it can provide an accessible point of care investigation which can be performed by an IBD specialist in the outpatient setting. This has the potential to provide immediate treatment altering decisions in the case of an acute IBD flare, aid in endoscopic triage based on severity of findings and reduce the number of invasive tests in cases with a low pretest probability.7 Of note this may be particularly useful in ruling out non-inflammatory conditions such as irritable bowel syndrome and reducing endoscopy demand. Reassuring or normal ultrasound parameters could also be used to justify de-escalation of some
Dr Ella Patchett
Dr Karl Hazel
immunosuppressants and therefore reduce medication exposure for patients. It also serves to escalate therapy in patients on biologics who have not fully responded to treatment and while not listed as a formal target in the updated STRIDE-II treat-to-target guidelines for IBD, IUS is recommended as an adjunct to endoscopy, cross-sectional imaging and biomarkers.a
By providing real time information at the patient’s bedside, IUS can have a positive effect on patient understanding of their own condition. Patients with IBD have been shown in the literature to potentially have a poor level of knowledge surrounding their condition and this is particularly prevalent in the pregnant population.11, 12 Misconceptions and false information can lead to detrimental actions such as stopping biologic medications, increasing the risk of a flare during pregnancy. Patients who have undergone point of care IUS have been shown to have a significant self-reported active disease reported better understanding of all aspects of their disease and disease symptoms and were
more confident in their ability to make informed decisions about managing their disease.10 There are pregnancy-specific IBD clinics in Ireland and by introducing IUS, particularly in these clinics, we can help improve patient knowledge, provide reassurance and also prevents unnecessary radiation to pregnant individuals if further investigations are required. While there are limited studies investigating the use of IUS in pregnancy, the studies thus far have shown that IUS is a useful tool in pregnancy and can detect subclinical inflammation and stratify active inflammation in symptomatic patients.13
Lastly, despite improvements in biological therapy, surgical intervention is required in a significant proportion of patients with IBD.14 Long term inflammation increases the risk of developing strictures, abscesses and fistulae and may ultimately result in emergency surgery.15 While CT and MRI remain the gold standard for postoperative assessment, IUS offers a rapid, bedside, and radiation- and bowel preparation-free alternative for early detection of postoperative
recurrence. Furthermore, this use of IUS, in combination with faecal calprotectin, has been proven to be a valid and reliable tool for monitoring postoperative patients with CD, predicting the risk of postoperative recurrence, allowing for earlier escalation or reinstatement of biologics.16
Limitations
With every imaging modality, there are limitations. CT can provide high resolution images of bowel and extraintestinal complications whilst also being readily available particularly in emergency situations such as suspected perforation.14 As mentioned, CT is associated with radiation exposure which is a concern for the predominantly young demographic of patients who require frequent scanning. MRE can provide a radiation free alternative to CT and can provide high diagnostic accuracy for detecting the presence and activity of CD with reasonable interobserver agreement.4 This is in direct comparison to IUS which has the potential to be limited by operator skill and inter-operator variability. Patient preference and experience is also a crucial role in determining a choice of modality.
The METRIC trial found that while the overall burden of MRE was relatively low, it was still notably higher than that of IUS and patient willingness to undergo repeat testing was less when compared to IUS.9
In conclusion, the field of inflammatory bowel disease continues to evolve and the role of IUS is becoming increasingly significant due to its non-invasive nature, real-time assessment and radiation-free advantages. While traditional imaging modalities such as MRI, CT, and endoscopy remain important in IBD diagnosis and management, IUS offers a costeffective, accessible, and patientfriendly alternative, particularly for disease monitoring and treatment response evaluation. Increased training, investment, awareness of IUS’s diagnostic accuracy and patient benefits will see it become a key component in Ireland’s IBD care strategy. Moving forward, a multimodal approach combining endoscopy, cross-sectional imaging, and IUS will likely optimise disease management, ensuring patients receive timely and effective care.
References available on request
Stroke
Young Stroke Mechanisms
Written by Dr Johann Leunbach, Dr Shameer Rafee and Professor Niall Tubridy
Strokes are a major cause of disability. “Young strokes” (strokes in people under the age of 50) have been increasing worldwide. Stroke and TIA (transient ischaemic attack) symptoms can be variable; any individual presenting with sudden onset focal neurological deficit(s) should be evaluated for a neurovascular cause.
Young strokes were thought to be due to rare aetiologies, but classic risk factors such as atherosclerosis, hypertension and diabetes mellitus, remain important. All strokes should be assessed with a similar methodical approach, although there are some differences in young stroke mechanisms that clinicians should bear in mind. The TOAST criteria provide a useful classification system of stroke mechanisms (Table 1). Targeted investigations and management can illuminate underlying causes and reduce risk of recurrence.
TOAST criteria
Large vessel occlusion (LVO)
Small vessel occlusion (SVO)
Cardioembolic (CE)
Stroke of determined source (SDS)
Cryptogenic stroke (CS)
TABLE 1- TOAST criteria.
TOAST= Trial of ORG 10172 in Acute Stroke Treatment
Dr Johann Leunbach
LVO is largely a reflection of accumulated cardiovascular risk factors over time and includes intracranial and extracranial stenoses. It accounts for 1020% of all strokes; a figure that is probably higher in certain ethnicities (e.g., Asian/ black cohorts). Prevalences in young strokes are variable. One study, which included patients up to the age of 55 years, suggested that up to 18% of ischaemic strokes/ TIAs are due to LVO. However, this was mostly confined to patients over 45 years. Vascular imaging with CT/MR angiography is an important part of stroke workup. Carotid doppler ultrasound is frequently used, particularly in patients who do not meet criteria for thrombolysis or thrombectomy. Carotid doppler will not capture intracranial LVO but may be sufficient in some clinical contexts.
SVO leading to stroke is rare in the younger cohort with prevalence increasing from the age of 40. This stroke mechanism is strongly linked to traditional cardiovascular risk factors. Lacunar strokes (small, subcortical infarcts), due to occlusion of penetrating arteries, define strokes from SVO. Certain stroke patterns are associated with lacunar infarcts including pure motor or sensory deficits, ataxic hemiparesis or mixed sensorimotor symptoms.
CE stroke accounts for upwards of 45% of young strokes. CE strokes can occur due to atrial fibrillation (most common), cardiomyopathy, valvular disease, cardiac thrombus and infective endocarditis causing septic emboli. Patent foramen ovale (PFO) is a common cardiac malformation and an important consideration in patients labelled as cryptogenic. All stroke patients should have an ECG. Telemetry is recommended to assess for paroxysmal arrhythmias. In some cases, prolonged cardiac monitoring, with a Holter monitor or a loop recorder, may be necessary to identify atrial fibrillation. Cardiac imaging is also required- transthoracic echocardiograms are usually readily available and, with bubble studies, may be able to
detect PFOs. The presence of a PFO does not indicate that it’s causative, as PFOs can be seen in up to 25% of the general population. Transoesophageal echocardiograms provide a more detailed assessment of PFO size and information on high-risk features e.g., aneurysmal/mobile septum and volume of bubbles being shunted. As PFOs are so common, it is crucial to carefully evaluate its role in stroke before considering interventions such as closure. Tools such as the RoPE (Risk of Paradoxical Embolism) score can help clinicians assess the likelihood of a PFO being the underlying cause.
SDS account for 20-30% of young strokes. Cervical artery dissection (CAD) involving carotid or vertebral arteries is the most common. Presentation can be variable. Historical and examination clues like neck trauma or manipulation, headache, tinnitus and presence of Horner’s syndrome can suggest CAD. CAD can be asymptomatic and an incidental finding on imaging. Strokes from CAD can occur many days after the initial injury. CT or MR angiography are first line investigations when dissection is suspected.
Connective tissue disorders can predispose to CAD but patients typically present with other features like poor wound healing or recurrent joint dislocations. Antiphospholipid syndrome and other hypercoagulable states (e.g., active malignancy), inflammatory syndromes, iatrogenic injuries, drug use, hypoperfusion and genetic conditions all fall under SDS. Genetic conditions that predispose to small vessel disease are still classified as SDS e.g., CADASIL (cerebral autosomal arteriopathy with subcortical infarcts and leukoencephalopathy) and CARASIL (cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy).
CS accounts for 25% of all young strokes. CS is a diagnosis of exclusion, and a detailed series of investigations are warranted. Risks of recurrence are variable, but some studies suggest that early recurrence could be as high as 6%. An important factor in CS is the advanced methodology for investigating potential causes: high definition MRI and angiography,
TOE and laboratory investigations for autoimmune and inflammatory causes for stroke. A significant proportion of CS are thought to be cardioembolic in origin and these patients should be considered for long term implanted rhythm monitoring (loop recorder). These patients may show evidence of intracranial atherosclerosis. Even mildly stenotic vessels can harbour unstable plaques, although identifying and treating these can be challenging. Transitory causes of CS exist that can be difficult to diagnose e.g., dissected vessels can heal quickly and appear normal on vessel imaging, despite being causative for stroke. Cancer is an important cause of coagulopathy and patients with CS can have occult malignancies. Appropriately, a very high threshold is needed for diagnosis of CS.
Stroke in the young person is associated with significant long-term morbidity and increased mortality. It also has an outsized economic impact, as it disables victims during their most productive years. Preventing stroke in both primary and secondary settings should focus on modifiable risk factors such as smoking, hypertension, diabetes and obesity. While initial assessment of the stroke victim remains the same whether young or old, the treating clinician should bear in mind that stroke mechanisms differ and treatments should reflect this. Tailoring further investigations and treatment may identify pathology that would otherwise have been missed.
References
1. Smajlović D. Strokes in young adults: epidemiology and prevention. Vasc Health Risk Manag. 2015 Feb 24;11:157-64. doi: 10.2147/VHRM.S53203.
2. Putaala J, Martinez-Majander N, Saeed S, et al. Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Triggers, Causes, and Outcome (SECRETO): Rationale and design. Eur Stroke J. 2017 Jun;2(2):116-125. doi: 10.1177/2396987317703210.
3. Kim J. Griffin, MD, William S. Harmsen, MS, Jay Mandrekar, et al. AHA Journals. 2014 Jan https://doi.org/10.1161/ STROKEAHA.123.043647
HIQA PUBLISHES UPDATED NATIONAL GUIDELINES FOR CONDUCTING ECONOMIC EVALUATION AND BUDGET IMPACT ANALYSIS IN HEALTH TECHNOLOGY ASSESSMENTS
The Health Information and Quality Authority (HIQA) has published updated guidelines for conducting economic evaluation and budget impact analysis in health technology assessments (HTAs). The guidelines are intended to inform economic evaluations or budget impact analyses conducted by, or on behalf of HIQA, the National Centre for Pharmacoeconomics (NCPE), the Department of Health and the Health Service Executive, as well as health technology developers preparing applications for reimbursement.
HTAs are used to help decide which health technologies (such as drugs, procedures, medical devices, broader public health interventions and service delivery models) should form part of the publicly-funded health and social care system. It is therefore important that best-practice methodologies are used when conducting HTAs. A suite of national HTA guidelines has been developed by HIQA based on international best practice. HIQA updates these guidelines to ensure they incorporate the most up-to-date and relevant scientific information, based on research and experience both nationally and internationally.
Publication of these updated economic guidelines follows a public consultation that was held from 21 October to 2 December 2024. The feedback received was carefully considered. Submissions and responses to them are documented in a statement of outcomes report, which has also been published.
Dr Máirín Ryan, HIQA's Deputy CEO and Director of Health Technology Assessment said: “A HTA involves the systematic evaluation of health technologies. Economic evaluation and budget impact analysis are often conducted as part of a HTA. Economic evaluation compares the costs and benefits of different choices to see which one is the best use of public resources. Budget impact analysis helps decision-makers understand the impact on the healthcare budget of introducing a new technology.
These guidelines explain how economic evaluation and budget impact analysis in HTA should be
conducted to inform healthcare investments and policy decisions in Ireland.”
These guidelines were developed with the support of HIQA’s HTA Scientific Advisory Group, which comprises patients, researchers, policy-makers, health technology developers, clinicians and other national and international experts. Their input is crucial in ensuring that the guidelines are fit-forpurpose and of high quality, which in turn helps inform health policy decision-making and support safer, better healthcare.
NEW APPOINTMENT AT EDWARDS LIFESCIENCES
Edwards Lifesciences, the leading global structural heart innovation company, today announced the appointment of Emmet Kelly as Vice President, Plant General Manager for its cuttingedge manufacturing facilities in Castletroy, Limerick and Shannon.
Millions of patients worldwide suffer from structural heart disease, facing high mortality rates and severe quality of life limitations. At the Limerick plant, more than 500 employees are dedicated to manufacturing lifesaving breakthrough implantable devices such as surgical and transcatheter therapies to treat patients’ heart valves, helping them live longer, healthier lives.
In his role, Kelly will oversee all aspects of the Ireland operations, including manufacturing execution, talent development, process optimisation, and the implementation of continuous improvement programmes. He will also represent Edwards with external stakeholders, including local government, community organisations, and regulatory agencies.
Kelly brings over 25 years of medical technology industry experience, including nearly a
decade in the US, with a strong background in manufacturing, human resources, supplier management, and strategic project management. He has successfully led plant improvements and expansions and managed manufacturing across multiple lines and locations. Kelly holds a Master of Industrial Engineering from University College Dublin.
“I am honoured to join Edwards and lead the Irish facilities, which play a vital role in the company’s global supply chain,” said Kelly. “I look forward to working with the talented team in Ireland, inspired by our patient-focused culture to pioneer and deliver innovative, lifechanging medical technologies to patients around the world.”
IRISH CANCER
SOCIETY CALLS ON PEOPLE AFFECTED BY PROSTATE CANCER TO SHARE THEIR EXPERIENCE IN PIONEERING
RESEARCH SURVEY
Men living with prostate cancer and their partners are being called on to take part in a pioneering anonymous survey led by Cancer Trials Ireland with funding from the Irish Cancer Society.
Around 4,000 men are diagnosed with prostate cancer in the Republic of Ireland each year, and about 1 in 7 men will be diagnosed with prostate cancer in their lifetime.
The groundbreaking PROACT (Patient-led Research On sexual experience After Cancer Treatment) Survey aims to understand how prostate cancer treatment affects intimacy, mental health, and quality of life for both patients and their partners.
It also aims to identify gaps in patient care regarding the sexual side effects of prostate cancer treatment, inform improvements, and amplify the patient voice.
The survey is led by co-chief investigators Martin Sweeney, who was diagnosed with prostate cancer in 2015 and is a member of Cancer Trials Ireland’s patient consultant committee, and Dr Paul Kelly, a radiation oncologist, under the guidance of Cancer Trials Ireland.
PRO-ACT Survey co-chief investigator Martin Sweeney said: “Prostate cancer is a muchmisunderstood disease. It very often results in long-lasting, and sometimes lifelong, adverse impacts on men and their partners. Issues with incontinence and sexual dysfunction are common during and after treatment.
“We want to better understand the experiences of men who have been diagnosed with prostate cancer and their partners, so services and supports can be improved to better meet their needs.
“If you or your partner have been treated for prostate cancer on the island of Ireland, please help by completing the PRO-ACT Survey. It’s completely anonymous and mostly involves ticking some boxes. Taking part will help to make life better for future patients diagnosed with prostate cancer in Ireland.”
Dr Claire Kilty, Head of Research at the Irish Cancer Society, said: “The Irish Cancer Society is passionate about the crucial role of Public and Patient Involvement, or PPI, in research, and have been ensuring PPI is embedded in our funded research for many years.
“The PRO-ACT Survey presents a valuable opportunity for greater insight into the lived experience of people with prostate cancer and their partners. The patient voice is at the centre of the survey and input from people affected by prostate cancer and their partners can make a real difference to the care people will receive going forward.
“We’re proud to fund pioneering research like the PRO-ACT Survey, and we encourage everyone who is eligible to take part.”
The separate patient and partner surveys are anonymous, take approximately 20 minutes to complete and can be completed in several sittings. They will close at the end of April and are available at PRO-ACT Prostate Cancer Survey - Cancer Trials Ireland
Emmet Kelly
Dr Claire Kilty, Head of Research, Irish Cancer Society
Clinical R&D
ALK’S ALLERGY TREATMENT
ACARIZAX®(12 SQ-HDM SLIT) - NOW APPROVED FOR CHILDREN AGED 5+ IN IRELAND
ALK has announces that ACARIZAX® has received a paediatric indication extension for the treatment of moderate to severe house dust mite allergic rhinitis disease, making it available for children aged 5 years and older in Ireland. Previously approved for patients aged 12+, this development marks a milestone in allergy treatment, broadening access to an innovative therapy that addresses the underlying cause of house dust mite allergic rhinitis. Studies suggest that allergic rhinitis is the most common allergic condition, affecting approximately 26% of Irish people, with house dust mites being the most common allergen.The condition can lead to disturbed sleep, impaired concentration, worsened asthma symptoms, school absenteeism and increased psychosocial burden.
ACARIZAX® is a sublingual immunotherapy (SLIT) tablet designed to treat the root cause of house dust mite allergy rather than just alleviating symptoms. By gradually desensitising the immune system, SLIT helps reduce the severity of allergic reactions over time, leading to long-term symptom relief and reduced reliance on symptomatic medications such as antihistamines and nasal steroids.
Dr Juan E Trujillo Wurttele and Dr Sadhbh Hurley together as the paediatric allergy team in Cork University Hospital and coordinators of the MSc of allergy and clinical immunology in UCC said, “House dust mite allergic rhinitis is often overlooked but can profoundly impact children’s daily lives. Expanding Acarizax’s indication to younger children represents a major step forward in addressing this unmet medical need, providing a long-term treatment option that can improve both symptoms and overall quality of life.”
ACARIZAX® has been approved for reimbursement in the UK through the NHS for the treatment of moderate to severe house dust mite allergic rhinitis disease in people 12 to 65 years that is persistent despite symptom relieving medicine, following a positive recommendation from NICE (National Institute for Health and Care Excellence). This expands access for eligible patients, providing them with a clinically proven, long-term treatment option that can
significantly improve quality of life while also relieving a financial burden for patients.
ALK General Manager Emil Stage Olsen added, “This extension brings the benefits of Acarizax to younger children. This approval reflects our ongoing dedication to transforming allergy treatment and providing healthcare professionals with advanced solutions for paediatric allergic rhinitis management. It aligns with ALK’s broader mission to improve allergy management and enhance patient outcomes.”
For more information about ACARIZAX® and ALK’s commitment to allergy care, visit www.alk.net.
AYA EXTENDS THREE YEAR BRAND AMBASSADOR PARTNERSHIP WITH ROBBIE HENSHAW THROUGH TO 2028
AYA, a leading name in the health and wellness supplement space, is proud to an-nounce the extension of its partnership with Irish International Rugby Player Robbie Henshaw for an additional three years. Having first joined the brand in 2023, Robbie will continue to serve as the official brand ambassador through 2028, reinforcing the shared commitment to promoting health, fitness, and overall well-being.
Robbie Henshaw, known for his sporting achievements, has been an integral part of AYA’s journey over the past two years. Through inspiring collaborations, engaging campaigns, and authentic endorsements, Robbie has helped elevate the brand’s presence within retail pharmacies and impact within the wellness community. The re-newed partnership solidifies
Irish International Rugby Player
the mutual success and continued vision of both parties.
AYA is six years in market and has seen double digital growth every year since launch. Last year +37% growth. It is the number one vitamin brand in Allcare and Hickeys and is sold in over 1500 pharmacies nationwide.
“We are excited to extend our partnership with Robbie Henshaw for another three years,” said Jackie Kelly, Business Development Director of Uniphar. Robbie’s passion for wellness and dedication to excellence have played a crucial role in AYA’s brand’s growth within pharmacies over the last two years. We look forward to continuing this successful collaboration and inspiring even more people on their health and fitness journeys’’.
As part of the extended agreement, Robbie Henshaw will remain a key figure in mar-keting campaigns, social media promotions, and upcoming product launches. Robbie will continue to share his personal experiences using AYA’s products, offering fans and followers a genuine perspective on their benefits.
Robbie Henshaw comments on partnership, “I am honoured to continue my partner-ship with AYA. Since 2023, I have seen firsthand their dedication to quality and innova-tion in the wellness space. Being a professional athlete requires stamina, concentra-tion, and a very intense training regime, AYA’s vitamins help me to keep on top of my health and well-being. And I’m excited to keep working together to motivate and empower individuals to prioritize their health and well-being too.
"We were delighted to have brought AYA and Robbie together two years ago, and their three-
year extension proves our belief that when excellence meets excellence in au-thentic partnerships, everyone wins!" –commented Trevor Twamley, CEO of Sport En-dorse.
AYA an Irish owned company is committed to delivering only the highest quality food supplements and vitamins to support health and well-being for all the family. The range of 44 products caters for adults, children, and babies. Exclusive to Irish phar-macy AYA is widely available across the country including Allcare Pharmacy, Life Pharmacy, Hickeys Pharmacy, McCauley Pharmacy, and other leading Groups and Independent Pharmacies, where staff are trained to give advice and guidance on appropriate products. AYA’s researchbacked products are formulated by scientists to deliver noticeable health benefits to customers and are gluten-free and vegan-friendly or vegetarian.
The distinctive blue bottles of AYA’s adult range reflect the iconic apothecary of the old world, with contents that have been formulated based on the latest cutting-edge research. While many of AYA’s colourful kids and baby range are unique products that contribute to the overall development in healthy children, and others help to support certain requirements or conditions.
A HAPPY MOUTH IS A HAPPY MIND – WORLD ORAL HEALTH DAY MESSAGE, 20TH MARCH 2025
Looking after your oral health is a positive step to taking better care of yourself. Each small step added to your daily brushing routine can lead to a brighter smile and lessen the risk of dental and gum disease. From infancy to old age.
World Oral Health Day is an annual event to raise awareness of the importance of oral care of your mouth, teeth, gums, and yourself. The Dental Health Foundation endorses this important message.
Oral health and overall health and well-being are interconnected. Poor oral health increases the risk of developing noncommunicable diseases, for example, cancer, diabetes, respiratory, cardiovascular, and Alzheimer's disease. The World Health Organisation points to 3.5 billion people worldwide suffering from oral disease (half the world population), and 90% of adults will experience cavities at some stage in their lives.
The Dental Health Foundation Ireland’s recent survey discovered that the Irish adult has room for improving their oral hygiene and care practices. In a study of 1,000
Robbie Henshaw
people nationwide, 59% of adults brushed twice daily; however, only 49% brushed before bed, despite this time being the most important time in the day.
Spit out toothpaste and don’t rinse after brushing is the best advice, to keep the fluoride in the paste protecting your teeth. Of the cohort that are brushing daily, only 17% follow this advice, and 31% rinse after brushing.
ASTELLAS’ PADCEVTM (ENFORTUMAB VEDOTIN) PLUS KEYTRUDA® (PEMBROLIZUMAB) SHOWS LONG-TERM EFFICACY IN FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER (LA/MUC)
Astellas Pharma Inc. CEO: Naoki Okamura, recently announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of enfortumab vedotin, a Nectin-4 directed antibody-drug conjugate, plus pembrolizumab, a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/ mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months). This data was presented during a rapid oral session (Abstract 664) at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025.
Thomas Powles, M.R.C.P., M.D., Professor of Genitourinary Oncology at Queen Mary University of London; Director, Barts Cancer Center, London; EV-302 Primary Investigator said, “These latest findings from the EV-302 trial reaffirm the primary results, which demonstrated survival improvements for patients treated with enfortumab vedotin and pembrolizumab that were previously unprecedented in locally advanced or metastatic urothelial cancer. These data show that the potential survival benefit has become even more robust with extended follow up and further solidify the combination as standard of care.”
Results showed enfortumab vedotin plus pembrolizumab reduced the risk of death by 49% versus chemotherapy (hazard ratio [HR] = 0.51, 95% confidence interval [CI], 0.430.61). The median OS was 33.8 months for the combination versus 15.9 months for chemotherapy. The OS benefit was observed in all prespecified subgroups,
including cisplatin eligible and ineligible subgroups. Enfortumab vedotin plus pembrolizumab also reduced the risk of disease progression or death by 52% versus chemotherapy (HR = 0.48, 95% CI, 0.41-0.57). The median PFS was 12.5 months for the combination versus 6.3 months for chemotherapy. The safety profile was consistent with previous findings and no new safety concerns were identified.
In addition to longer follow-up data, an exploratory analysis evaluating treatment outcomes and safety profile in patients with confirmed complete response (cCR) will also be presented. Among patients evaluable for response, confirmed objective response rate (cORR) was 67.5% for enfortumab vedotin plus pembrolizumab compared to 44.2% for chemotherapy. Median duration of response (DOR) was 23.3 months (95% CI, 17.8-not estimable [NE]) for the combination and 7.0 months (95% CI, 6.2-9.0) for chemotherapy. A cCR was achieved in 30.4% of patients treated with enfortumab vedotin plus pembrolizumab and 14.5% of patients treated with chemotherapy. Median duration of cCR was not reached for the combination and 15.2 months (95% CI, 10.3-NE) for chemotherapy. In patients with cCR, grade ≥3 treatment-related adverse events occurred in 61.7% of patients in the enfortumab vedotin plus pembrolizumab arm compared to 71.9% in the chemotherapy arm. There were no treatment-related deaths in the cCR subgroup.
SKIN CANCER IN IRELAND: NEW REPORT SHOWS NEARLY 100% SURVIVAL RATE FOR MOST CASES.
A new report published by the National Cancer Registry of Ireland shows good news for skin cancer patients with most people (close to 100%) surviving at least five years after being diagnosed with non-melanoma skin cancer. For melanoma, the more serious type of skin cancer, survival rates have improved significantly to 92% (meaning about 9 out of 10 patients survive at least five years).
Key facts:
• More than 11,000 people in Ireland are diagnosed with skin cancer each year, making skin cancer the most common cancer in Ireland.
• About 9 out of 10 cases are nonmelanoma skin cancers (NMSC), other types include melanoma.
• Almost all non-melanoma patients survive at least 5 years, whereas about 9 out of 10
melanoma patients survive at least 5 years.
• About 270 people die from skin cancer each year in Ireland. What the numbers tell us about different groups:
The incidence rate of certain NMSC cancers (squamous cell carcinoma or SCC) is decreasing in women, and the rate for other forms (basil cell carcinoma or BCC) is stabilising. However, the incidence rate for melanoma in women continues to increase.
For men, the incidence rate of SCC is stabilising, while the BCC incidence rate is increasing at a slower pace. For melanoma, the incidence rate in men stopped increasing since 2015.
Men are more likely to die from skin cancer than women:
• 1.6 times more likely to die from melanoma.
• 2.3 times more likely to die from non-melanoma skin cancer.
Why survival rates are so good: Most skin cancers (both melanoma and non-melanoma) are caught early (at stage I or II), which makes them much easier to treat successfully.
Commenting on the report, Professor Deirdre Murray, Director of the National Cancer Registry said, "Understanding the trends in skin cancer is vital for public health awareness and prevention strategies. Many of these cancers could be prevented with wider adoption of safe sun practices in our population and avoidance of sun beds."
WEGOVYTM(SEMAGLUTIDE 2.4 MG) AVAILABLE IN IRELAND TO TREAT OVERWEIGHT AND OBESITY
Wegovy® (semaglutide 2.4 mg) is a once-weekly subcutaneous injection that belongs to a class of medicines called glucagonlike peptide-1 (GLP-1) receptor agonists. It is approved by the European Medicines Agency (EMA) for weight management as an adjunct to diet and physical activity to help adults and adolescents, living with a prespecified Body Mass Index (BMI) and/or certain weight-related conditions to lose weight and maintain this weight loss.
Ireland becomes one of more than 15 countries around the world to make Wegovy® available.
This treatment, which must be prescribed by a healthcare professional on prescription, and will be dispensed through
pharmacies, is indicated for chronic weight management. It is intended as an adjunct to a reduced-calorie diet and increased physical exercise for:
• Weight control, including weight loss and maintenance, in adults with a BMI of ≥30 kg/m2 (obesity).
• For weight management, including weight loss and maintenance, in adults with a BMI of ≥27 kg/m2 to <30 kg/ m2 (overweight) and at least one weight-related comorbidity (e.g., blood glucose disturbances such as pre-diabetes or type 2 diabetes mellitus, hypertension, dyslipidemia, obstructive sleep apnoea, or cardiovascular disease).
The clinical evidence for the drug is based on the STEP (Semaglutide Treatment Effect in People with Obesity) clinical trial programme, conducted by Novo Nordisk, which has shown that semaglutide at a weekly dose of 2.4 mg enables weight reduction in one out of three patients by 20%, as well as a clinically significant average weight reduction of ~17%, maintained over 2 years. Additionally, the clinical trial named SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) conducted by Novo Nordisk, has demonstrated that semaglutide 2.4 mg leads to a statistically significant reduction of major adverse cardiovascular events (MACE) by 20% compared to a placebo.
Dr Donna Sexton, Clinical, Medical & Regulatory Director, Novo Nordisk Ireland outlines that: “Glucagon-like peptide-1 (GLP1) is a hormone involved in the physiological regulation of appetite and calorie intake. Semaglutide acts as a GLP-1 receptor agonist, i.e., it selectively binds to the GLP1 receptor and activates it. This molecule has a dual effect. On the one hand, clinical trials show that it increases the feeling of satiety and fullness and reduces the frequency and intensity of the feeling of hunger, consequently decreasing caloric intake. On the other hand, it has also shown the ability to lower the level of glucose in the blood, which implies a slight delay in gastric emptying after eating.”
Nina Hovland, General Manager and Vice President of Novo Nordisk Ireland said: “In Ireland, we are seeing positive developments addressing the high prevalence of obesity; there is recognition that obesity is a chronic disease; we have an ‘Obesity Model of Care’ and ‘Clinical Guidelines’ in place and importantly, a commitment to a new ‘Obesity Policy and Action
Clinical R&D
Plan’, included in the Programme for Government.
“It is very exciting to launch a product that doesn’t just deliver a loss of weight, but a gain in health. Weight is not just about a number, but the benefits that a treatment can provide alongside the loss of weight.
“I am also encouraged to see that one of the first official events by our new Minister for Health, Jennifer Carroll MacNeill T.D., was to host the World Health Organisation (WHO), ‘Demonstration Platform on the Prevention and Treatment of Obesity’, to learn from obesity initiatives in Ireland. This is a significant step for Ireland, signalling a clear intent to address the chronic disease of obesity and builds on the progress that has already been made.
As a company that is dedicated to bringing innovative treatments to people living with obesity, being part of that change in Ireland is exciting and makes me very proud.”
Professor Carel Le Roux said:
“Today’s announcement of the availability of semaglutide 2.4 mg1 for people living with the disease of obesity in Ireland represents a significant development in obesity management. Semaglutide 2.4 mg has demonstrated clinically meaningful weight loss when combined with diet and exercise.
“Semaglutide 2.4 mg was evaluated in the STEP phase 3 clinical trial programme, which included more than 5,000 study participants. Trial data showed that semaglutide 2.4 mg resulted in significantly greater weight loss and health gains versus comparator arms.
“Additionally, in patients with pre-existing cardiovascular disease and a BMI ≥ 27 kg/m2 , but without diabetes, semaglutide 2.4 mg was superior to placebo in reducing the incidence of death from cardiovascular causes, non-fatal myocardial infarction, or non-fatal stroke.”
DUBLIN RESEARCH
TEAM DEVELOPS NEW INTERNATIONAL GUIDELINES
A groundbreaking new guideline developed by an international team of researchers, led by Irish experts from UCD, RCSI, and St John of God Hospital, has been recognised as providing a clear framework for preventing significant weight gain associated with antipsychotic medications. Published in Schizophrenia Bulletin, the guideline addresses
a critical gap in clinical practice by offering evidence-based recommendations on the use of metformin, a well-established diabetes medication, to mitigate this distressing side effect.
About 1,500 people develop a psychotic disorder for the first time in Ireland every year and one percent of the population will experience an episode of psychosis in their lifetimeequivalent to 54,000 people across the Irish population.
Most individuals experiencing a first episode of psychosis gain a substantial amount of weight within months of starting antipsychotic treatment, a side effect that can severely impact their long-term physical health.
While lifestyle interventions like diet and exercise are often recommended, the rapid onset of weight gain makes it challenging to counteract with these measures alone. Research has shown that metformin is most effective when introduced alongside antipsychotic treatment or at the earliest signs of weight gain.
“For decades, studies have highlighted metformin’s potential to manage antipsychotic-induced weight gain, but there was no clear guidance on how and when to use it,” says Aoife Carolan, first author of the study and a pharmacist at St John of God Hospital, as well as a PhD student at RCSI. “Our guideline seeks to bridge this gap, providing clinicians with a practical tool to safely and effectively prescribe metformin to prevent excessive weight gain.”
The guideline is distilled into a one-page algorithm containing three core recommendations and essential prescribing information.
It is part of the PROGRESS research initiative, led by Prof Brian O’Donoghue from UCD, and is funded by the Health Research Board as part of a broader effort to improve national psychosis treatment protocols. The research team includes psychiatrists, endocrinologists, general practitioners, pharmacists, people with lived experience of psychosis, and international experts.
Michael Norton, lead PPI representative with PROGRESS, emphasised the importance of prioritising physical health in psychiatric treatment. “It is vital that clinicians consider the physical effects of antipsychotic medications. This guideline encourages a holistic approach to treatment, ensuring service users receive comprehensive support in their recovery journey.”
Professor Donal O’Shea, National Lead for Obesity with the HSE, welcomed the publication, stating, “Obesity prevention is critical, and we now understand that medication plays a significant role in weight gain. These guidelines will help identify those most at risk and ensure timely intervention with metformin to mitigate this impact.”
LIFESAVING BOWEL CANCER SCREENING UPTAKE GOING BACKWARDS, CHARITY WARNS
The Irish Cancer Society has warned that lifesaving bowel cancer screening uptake is going backwards. That’s according to the latest available data released by the HSE for 2024.
Marking the beginning of Bowel Cancer Awareness Month (April), the charity is concerned that in 2024, Ireland’s already low target of 45% uptake in bowel cancer screening was missed, with just 41% of those eligible participating.
Around 2,500 people are diagnosed with bowel cancer each year and it is the second most common cause of cancer-related death in Ireland. The earlier bowel cancer is detected the better the outcome for the patient.
Steve Dempsey, Director of Advocacy & Communications at the Irish Cancer Society said: “Screening saves lives. It can detect bowel cancer before signs or symptoms are even present, and that means better outcomes and less harsh treatment pathways. But in 2024, only 2 in 5 people who were eligible to participate in BowelScreen actually took part. The Irish Cancer Society is deeply concerned that the uptake in lifesaving bowel cancer screening is going backwards. Ireland’s target uptake is just 45%, which is nowhere near the EU recommended bowel cancer screening target uptake of 65%.”
He continued: “There is good news. From today, the age eligibility of BowelScreen has been expanded from 59-69 to 59-70. That’s about 48,000 more people eligible over the next two years. But without greater uptake, eligibility means little.”
Tom McHugh, aged 64, from Dublin was diagnosed with bowel cancer in July 2023. It was only after his wife, who is younger than him, received her home test kit, he realised he hadn’t received his own. Tom proactively phoned the service to make sure he was registered and shortly afterwards received his home test kit. It was through BowelScreen that his bowel cancer was detected. Calling for more people to take part in bowel cancer screening,
Tom McHugh said: “It is quite worrying to me that well over half of people who could be participating aren’t doing so. I am proof that screening works, and for anyone hesitating, I would strongly encourage you to please participate. I was fit and healthy. I had no symptoms whatsoever and yet bowel cancer was there, and it would have gotten a lot worse had it not been caught early through the screening programme.”
Prof. Barbara Ryan, Consultant Gastroenterologist, Tallaght University Hospital & Clinical Professor, Trinity College Dublin, said: “This Bowel Cancer Awareness Month, and every month, it is so important for people to be aware of the possible signs and symptoms of bowel cancer. What we are particularly asking people to look out for is persistent changes – changes that last longer than 3 weeks. Symptoms such as changes in your toilet habits, blood in your poo, weight loss, pain or bloating in your abdomen area and so on can be caused by other things. But if your symptoms have gone on for more than 3 weeks, go to your GP. You can get referred for further testing to either rule out bowel cancer or to detect it as early as possible.”
Signs and symptoms of bowel cancer include:
• Changes in your poo that last longer than 3 weeks.
• A lump, pain, or bloating in your tummy.
• Feeling you have not emptied your bowel fully.
• Losing weight for no reason.
• Blood in your poo, which may look red or black.
• Feeling very tired or breathless.
• Bleeding from your bottom.
Professor Barbara Ryan
For anyone with queries related to bowel cancer, the Irish Cancer Society’s freephone Support Line can be reached at 1800 200 700 or by email at supportline@irishcancer.ie.
CELEBRATING A WIN FOR
SUSTAINABILITY IN IRISH HEALTHCARE:
Health Innovation Hub Ireland (HIHI), with the HSE and the Irish College of GPs has announced the winners of its GreenTech in healthcare call today. The three leading healthcare organisations have identified six innovative products and services that promote environmental sustainability in both primary and secondary healthcare. The call was the first step in tackling the research and innovation gap in sustainable product pathways in the Irish health sector. Now, the winning products and services in green healthcare, will be trialled. This allows Irish health providers to pilot, refine and adapt sustainable solutions effectively, before wider implementation. HSE and Enterprise Ireland partnership, HIHI, will lead collaborations across Irish healthcare sites to deliver trialling on the ground.
Winners:
Aerogen: This HIHI GreenTech winner pitched a unique long term multi-disciplinary project developing sustainable medical devices, transitioning to a circular economy model and reducing the environmental footprint of Aerogen’s Solo Nebuliser
products. There are several stages to this work and HIHI looks forward to beginning the first stage, supporting research and problem definition, throughout Irish healthcare sites.
Vanguard AG: This HIHI GreenTech winner pitched a proven solution for the remanufacturing of single-use medical devices. HIHI looks forward to trialing this solution as part of a sustainability pilot in Irish healthcare.
HaPPE: This HIHI GreenTech winner pitched a full cycle biodigestion system, creating a sustainable solution for healthcare waste, specifically compostable PPE and food waste. The solution leverages compostable materials, on-site bio-digestion and advanced decontamination technology. HIHI looks forward to trialing this solution as part of a sustainability pilot in Irish healthcare.
EccoSpray: This GreenTech winner pitched an eco-friendly alternative to traditional ultrasound gels, to measure sustainability, waste reduction and efficiency benefits. The product has previously been trialed by HIHI with positive results on usability and image quality. HIHI now looks forward to trial this solution as part of a sustainability pilot in Irish healthcare.
Offerre: This HIHI GreenTech winner, a new consortium of Irish companies—Offerre, Envetec, DeltaQ, Enva - pitched a multifaceted solution focused on
medical waste treatment and recovery. HIHI now looks forward to mapping this solution to trial it as part of a sustainability pilot in Irish healthcare.
Medfirst Supplies - Safe clean box: This HIHI GreenTech winner, pitched a closed, sealed cabinet system that automates the manual cleaning of RIMDs. Uses sodium bicarbonate (non-abrasive, noncorrosive and water-soluble) with low-pressure compressed air for effective pre-cleaning of medical device. HIHI now looks forward evaluating this solution as part of its sustainability portfolio in Irish healthcare.
The pitches were judged by HIHI Clinical Sustainability Advisors (CSA) from across Ireland who
Some of the partners and winners of the first national HSE, ICGP, HIHI GreenTech in Healthcare call: Will Hogan Ecco Spray, Declan Lacey MedFirst, Eimear Galvin Health Innovation Hub Ireland, Philip Crowley, HSE, Roisin Breen, HSE, Oran Murphy, VanGuard AG and Conor Connelly, Offerre
work on the frontline, and a panel of experts from the HSE, Irish College of General Practitioners and Irish healthcare siteshealthcare sites, including St James’s, TUH, CUH, CUMH, UHG.HIHI, the HSE and the Irish College of GPs will now support the development and trialling of these innovative products and services.
HIHI National Director Dr Tanya Mulcahy said, “Today marks a significant step toward integrating sustainable innovation into Irish healthcare. By identifying and trialling these six pioneering solutions, Health Innovation Hub Ireland, with the HSE and the Irish College of GPs, is fostering real-world impact in environmental sustainability.
“The diversity of the selected products - from circular economy medical devices to eco-friendly ultrasound gels - demonstrates a broad commitment to tackling healthcare’s environmental footprint. This initiative sets a strong precedent for future collaborations in green healthcare innovation."
Some of the winners of the national HSE, ICGP, HIHI GreenTech in Healthcare call: Declan Lacey MedFirst, Will Hogan Ecco Spray, Lisa O’Riordan, HaPPE Earth, Conor Connelly, Offerre and Oran Murphy, VanGuard AG
