Simplicity. Reinforced .

for a BROAD RANGE of adults with type 2 diabetes (T2D)

UNIQUE CONVENIENCE through always one dose, once daily 1 5mg once daily

Demonstrated

CV AND KIDNEY SAFETY PROFILE 2,3

Proven Efficacy Vs Placebo

for adults with T2D 1,4

References:

1. TRAJENTA® (linagliptin) Summary of Product Characteristics. SmPC available at: https://www.medicines.ie/

2. Rosenstock J, et al. JAMA. 2019;321:69–79

3. Rosenstock J, et al. Cardiovasc Diabetol. 2018;17:39

4. McGill JB, et al. Diabetes Care. 2013;36:237–44

Prescribing Information (Ireland) TRAJENTA® (Linagliptin)

Film-coated tablets containing 5 mg linagliptin. Indication: Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment; combination therapy in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control. Dose and Administration: 5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia. Renal impairment: no dose adjustment required. Hepatic impairment: pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.

Elderly: no dose adjustment is necessary based on age. Paediatric population: the safety and ef cacy of linagliptin in children and adolescents has not yet been established. No data are available. The tablets can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as possible but a double dose should not be taken on the same day. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Hypoglycaemia: Caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin; a dose reduction of the sulphonylurea or insulin may be considered. Acute pancreatitis: Acute pancreatitis has been observed in patients taking linagliptin. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Trajenta should be discontinued. If acute pancreatitis is con rmed, Trajenta should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Bullous pemphigoid: Bullous pemphigoid has been observed in patients taking Linagliptin. If bullous pemphigoid is suspected, Trajenta should be discontinued. Interactions: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. It is not an inducer of CYP isozymes. Linagliptin is a P-glycoprotein substrate and inhibits P-glycoprotein mediated transport of digoxin with low potency. Based on these results and in vivo interaction studies, linagliptin is considered unlikely to cause interactions with other P-glycoprotein substrates. Effects of other medicinal products on linagliptin: The risk for clinically meaningful interactions by other medicinal products on linagliptin is low. Rifampicin: Multiple co-administration of 5 mg linagliptin with rifampicin, a potent inductor of P-glycoprotein and CYP3A4, decreased linagliptin steady state AUC and Cmax. Thus, full ef cacy of linagliptin in combination with strong P-glycoprotein inducers might not be achieved, particularly if administered long term. Coadministration with other potent inducers of P-glycoprotein and CYP3A4, such as carbamazepine, phenobarbital and phenytoin has not been studied. Effects of linagliptin on other medicinal products: In clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, warfarin, digoxin or oral contraceptives (please refer to Summary of Product Characteristics for a full list of interactions and clinical data). Fertility, pregnancy and lactation: The use of linagliptin has not been studied in pregnant women. As a precautionary measure, avoid use during pregnancy. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin therapy taking into account the bene t of breastfeeding for the child and the bene t of therapy for the woman.

No studies on the effect on human fertility have been conducted for linagliptin. Undesirable effects: Adverse reactions reported in patients who received linagliptin 5 mg daily as monotherapy or as add-on therapies in clinical trials and from post-marketing experience. Frequencies are de ned as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000). Adverse reactions with linagliptin 5 mg daily as monotherapy: Common: lipase increased. Uncommon: nasopharyngitis; hypersensitivity; cough; rash; amylase increased. Rare: pancreatitis; angioedema; urticaria; bullous pemphigoid. Adverse reaction with linagliptin in combination with metformin plus sulphonylurea: Very common: hypoglycaemia. Adverse reaction with linagliptin in combination with insulin: Uncommon: constipation. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 28 tablets. Legal category: POM. MA number: EU/1/11/707/003. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Crescent Building, Northwood, Santry, Dublin 9. Prepared in September 2021.

Adverse events should be reported. Reporting forms and information can be found at https:// www.hpra.ie/homepage/about-us/report-an-issue. Adverse events should also be reported to Boehringer-Ingelheim Drug Safety on 01 2913960, Fax: +44 1344 742661, or by e-mail: PV_local_UK_Ireland@boehringer-ingelheim.com

South Sudan’s first years as an independent state,” commented Irish Foreign Affairs Minister Simon Coveney at the time of the famine.

“We know that this is largely a man-made conflict. We can – and we will – keep giving humanitarian aid to save lives, but the only way we can move towards supporting long-term sustainable development in South Sudan is through a comprehensive political solution.”

But in the intervening years the country has continued to suffer greatly, with over eight million people estimated to be in need of humanitarian assistance in 2021, according to a report by the World Bank. Added to this already perilous situation is the Covid pandemic.

“Communities were hit hard by the triple shock of intensified conflict and sub-national violence, a second consecutive year of major flooding, and the impacts of Covid-19, exacerbating an already dire humanitarian situation,” the World Bank report said.

Health facilities are particularly badly impacted, Human Rights Watch says. “Conflict has caused health facilities to routinely face shortages of key medical supplies putting further civilian lives in danger. The fighting has also compounded food insecurity, with malnutrition becoming a greater threat.”

Against this background, it is easy to see why Dr Okeny’s work setting up a surgical service at a newly built hospital in a very remote area in South Sudan made such a difference for people. Indeed, the desire to make a difference in people’s lives was a major reason why he became a doctor in the first place in his native Uganda. His mother’s work as a midwife also inspired him to devote himself to medicine.

Karamoja

Dr Okeny was born in 1982 in the Karamoja Region, in north eastern Uganda. “I thought at an early age that the best way to serve the people was to be a doctor or [to work] in a similar profession,” he told MI

“I had a health background too because my mother was a midwife and I grew up within the premises of a local health unit in Karamoja.”

The Karamoja region is made up of dry grasslands and semi-nomadic cattle herders. The region’s dependence on agriculture makes people there vulnerable to changes in weather patterns and devastating droughts, which occur about every two to three years. Households that do not own livestock are particularly vulnerable to food insecurity.

But Karamoja is also a region with potential. It is ecologically diverse with opportunities for crop and livestock production and it has tourism potential. It is one of the most richly endowed regions in Uganda, with over 50 different minerals, including gold, silver, copper, iron, gemstones, limestone, and marble, although the scale and accessibility of all of these resources is not yet fully established. This represents a potential source of income for the region, but also increases the risks of exploitation, for example through land grabbing.

The Irish Government has been assisting Uganda as part of an aid programme that began back in 1994 and poverty rates have been declining in recent decades (from 50 per cent in 1992 to below 20 per cent in 2012).

Today Uganda is a growing economy and an important factor in the region, but there are high levels of inequality, according to an Irish Aid strategy paper. Over 90 per cent of people in Karamoja are classed as poor and vulnerable, as opposed to just under 11 per cent in the capital Kampala.

Uganda’s burden of disease is dominated by communicable diseases, which account for over 50 per cent of morbidity and mortality, according to the

World Health Organisation (WHO). Malaria, HIV/ AIDS, tuberculosis and respiratory, diarrhoeal, epidemic-prone, and vaccine-preventable diseases are the leading causes of illness and death. There is also a growing burden of non-communicable diseases, including mental health disorders. Maternal and perinatal conditions further contribute to the high mortality. Neglected tropical diseases remain a big problem in the country, affecting mainly rural poor communities. Dr Okeny said there are also wide disparities in health status across the country because of socio-economic, gender and geographical differences.

Surgical training

Driven by a desire to help alleviate such problems and equipped with a government scholarship to study medicine, in 2002 Dr Okeny headed to Mbarara, south western Uganda, for his undergraduate degree and went on to do his postgraduate degree in Makerere University in Kampala.

After five years of university, he went back to northern Uganda to do his internship from 2007 to 2008 at St Mary's Hospital in Gulu District. The hospital is administered and managed by the Catholic Archdiocese of Gulu and most of its funding comes from Italy.

Dr Okeny remained in Gulu for two more years doing further training before formally embarking on postgraduate surgical training.

Later, he was asked by CUAMM, the Doctors with Africa NGO, to set up a surgical service at one of their newly created hospitals in remote South Sudan.

“I was glad that I said yes because it was the best experience I have had as a doctor. There was a great need there for doctors. It was a very basic and very raw environment. The theatre was still under construction and almost no laboratory and not much human support around you, just one other doctor, no properly trained local nurses. It was very, very challenging.

“I treated lots of gunshot wounds. There were many tribal conflicts and cattle rustling. I remember treating a young man of about 24 who had gone to steal cattle and unfortunately sustained serious gunshot wounds. I found out later that his father was a chief in the local village. He was so happy and thanked me and promised me his daughter in marriage. I thanked him and said I would think about it.”

It was a rare moment of light relief for the young doctor.

When he returned to his native Uganda after 10 months, Dr Okeny faced a different set of challenges to those he had experienced in South Sudan. “I think the main problems in Uganda are not really medical, they are more about system and support issues, especially in rural areas.

“Uganda is producing a lot of doctors and has reasonable medical technology and service technicians. For example, five years ago endoscopy was a luxury, but now it’s available in most hospitals within the cities. Laparoscopy might be expensive, but it is available, though not in rural areas.

The major challenges affecting the health system are the lack of resources to recruit, deploy and retain health workers, particularly in remote localities; ensuring quality of the healthcare services delivered; ensuring reliability of health information in terms of the quality, timeliness, and completeness of data; and maintaining medicines and medical supplies.

The WHO says other key problems are the emergence of antimicrobial resistance due to the inappropriate use of medicines and poor prescription practices and the inadequate control of sub-standard, spurious, falsely labelled, falsified or counterfeit medicines.

The charity VSO Ireland launched a maternal and neonatal health programme in Karamoja in November 2018 with the help of funding from Irish Aid. This programme focuses on promoting and extending health services to pregnant adolescent girls, who are particularly at risk when giving birth, and to their babies. Irish volunteers work with Ugandan volunteers and local partners to increase local knowledge of disease prevention, diagnosis, and treatment to save the lives of more mothers and babies.

“As a surgeon you depend on other people doing their part, making sure there’s blood in the blood bank and that an oxygen supply is available. Sometimes you might have to sit down and wait for hours for all these things to be in place before you actually do the operation. So you could spend more than half of your day just waiting to do the operation.” These are the kinds of system issues he constantly faces, especially in remote areas.

The day after Dr Okeny spoke with this newspaper, he returned to his hospital in the Ugandan capital Kampala after a period as a research scholar at RCSI looking at patient-centred care, which he is now developing further in Uganda. “I have my qualifications, but at the end of the day everything centres around the patient. These are the people I want to help and I hope this improves my skills dealing with patients.”

Indeed, for Dr Okeny it all goes back to his reason for becoming a surgeon – helping people. He has spent much of his time caring for those in deprived rural areas by opening much-needed surgical departments in rural hospitals in his native Uganda and neighbouring South Sudan.

“In the cities it’s usually fine, there are plenty of doctors. But deep in the rural areas, in the villages, there are people who take months to see a doctor when they need one. Their need brings out the raw clinician in you. It brings you back to what you can do clinically. In the rural areas the doctor in you has to come out.”