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Inhaled Corticosteroids in COPD – A Closer Look

for patients without concomitant asthma is less clear cut and more nuanced.2 antagonist [LAMA]) versus dual LABA/ LAMA therapy, a 2021 systematic review and meta-analysis of six randomized controlled trials (n=13,579) found that triple therapy significantly decreased COPD exacerbations (rate ratio 0.73, 95% confidence interval [CI] 0.64–0.83), improved dyspnea and quality of life scores, FEV1 (forced expiratory volume in 1 second) and mortality (odds ratio 0.66, 95% CI 0.50–0.87) over six to 12 months.2 This analysis again demonstrated an increased risk of pneumonia with triple therapy compared to LABA/LAMA use (odds ratio 1.52, 95% CI 1.16–2.00).2 On average, participants were males in their 60s who were current or ex-smokers, with the two largest trials requiring two moderate or one severe exacerbation in the past year for study inclusion.2

Who is most likely to benefit from an ICS?

JILLIAN REARDON ACPR, PharmD, RPh

Chronic obstructive pulmonary disease (COPD), one of the leading causes of death globally, is characterized by progressive airflow limitation and lung tissue destruction.1 Bronchodilators are the mainstay of pharmacologic therapy and have been shown to improve dyspnea, quality of life and reduce exacerbations.1 While widely prescribed for COPD, the utility of inhaled corticosteroids (ICSs)

TABLE 1

COPD

Evidence summary

Several studies have demonstrated that compared to placebo, ICS monotherapy in COPD does not impact quality of life, exacerbations or mortality.1 The landmark TORCH study demonstrated that the combination of an ICS and long-acting beta agonist (LABA) did not reduce allcause mortality and increased the risk of pneumonia, in patients with moderate to very-severe COPD and at least one exacerbation in the previous year, when compared to LABA monotherapy.3 When examining the effect of triple therapy (ICS plus LABA plus long-acting muscarinic

Stages And Associated Spirometry And Symptoms

1 – Mild ≥ 80% predicted

*2 – Moderate 50%–79% predicted

*3 – Severe 30%–49% predicted

*4 – Very Severe < 30% predicted

1,8

Short of breath when hurrying on the level or walking up a slight hill

Walks slower than most people of the same age on the level because of breathlessness, or has to stop for breath when walking at own pace on the level OR

Stops for breath after walking about 100 metres or after a few minutes on the level

Too breathless to leave the house, or breathless when dressing or undressing

COPD–chronic obstructive pulmonary disease; FEV1 = forced expiratory volume in 1 second

*Patients in the moderate–very severe stages may benefit from addition of an inhaled corticosteroid (ICS) to long-acting beta agonist/long-acting muscarinic antagonist (LABA/LAMA) combination therapy depending on clinical status

The GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2022 guidelines and the Canadian Thoracic Society recommend stepping-up to triple therapy with an ICS for patients with moderate to very-severe COPD who are on LABA/LAMA therapy and continue to be symptomatic with risk for frequent and/or serious exacerbations (≥ 2 per year, or ≥ 1 requiring hospitalization) (Table 1). 1,4 Interestingly, a positive correlation has been established between elevated blood eosinophils (> 300 cells/ μL) and responsiveness to ICSs in COPD patients; however, prospective trials are required to inform the usefulness of this marker in determining who may benefit from an ICS add-on.1,4 Patients with concomitant asthma should continue to receive an ICS as routine care.1

Can ICSs ever be stopped?

In patients who are on ICS/LABA/LAMA triple therapy and are clinically stable with no exacerbations or hospitalizations for at least a year, consideration should be given to stopping the ICS.1 This is supported by the WISDOM trial, which randomized 2,488 adults with severe to very-severe COPD and frequent exacerbations on triple therapy to gradual ICS withdrawal over 12 weeks and continuation of LABA/ LAMA or continuation of triple therapy; the study found no significant difference in COPD exacerbations, symptoms or quality of life between groups.5

The subsequent SUNSET trial in adults with more stable COPD (compared to the WISDOM population) also found no difference in annual rates of moderate or severe exacerbations with abrupt ICS withdrawal and continuation of LABA/LAMA versus continuation of triple therapy.6 Finally, appropriateness of and need to continue ICS therapy should always be questioned in patients with repeated episodes of pneumonia.1

TABLE 2

Questions to assess if patients are obtaining meaningful symptomatic benefit from inhalers7

HAVE YOU NOTICED A DIFFERENCE SINCE STARTING THIS TREATMENT?

IF YES:

• Are you less breathless?

• Can you do more?

• Do you sleep better?

• Is this change worthwhile to you?

Pharmacist’s role

Prior to initiating an ICS, assess adherence as well as inhaler technique to ensure patients are fully optimized with LAMAs and LABAs.1,7 In patients who are prescribed an ICS (or any inhaler for COPD), follow-up every few months to see if they are noticing a meaningful symptomatic benefit (Table 2) 7 Those not noting any improvement in symptoms and/or a reduction in exacerbations may be candidates to consider for ICS deprescribing.1,7 If triple therapy is

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