Clinical Inquiries

What are the benefits and risks of inhaled corticosteroids for COPD?

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EVIDENCE-BASED ANSWER:

Inhaled corticosteroids (ICS), either alone or with a long-acting β agonist (LABA), reduce the frequency of exacerbations of chronic obstructive pulmonary disease (COPD) and statistically, but not clinically, improve quality of life (QOL) (strength of recommendation [SOR]: B, meta-analyses of heterogeneous studies).

However, ICS have no mortality benefit and don’t consistently improve forced expiratory volume in 1 second (FEV1) (SOR: B, meta-analyses of secondary outcomes). They increase the risk of pneumonia, oropharyngeal candidiasis, and bruising (SOR: B, meta-analyses of secondary outcomes).

Withdrawal of ICS doesn’t significantly increase the risk of COPD exacerbation (SOR: B, a meta-analysis).

EVIDENCE SUMMARY

A Cochrane meta-analysis designed to determine the efficacy of ICS in patients with stable COPD found 55 randomized, controlled trials (RCTs) with a total of 16,154 participants that compared ICS with placebo for 2 weeks to 3 years duration.1 COPD varied from moderate to severe in most studies.

In pooled data, ICS for 2 or more years didn’t consistently improve lung function, the primary outcome (TABLE). However, the largest RCT (N=2617) of 3 years duration showed a small decrease in decline of FEV1 (55 mL compared with 42 mL, P value not provided). Regarding the secondary outcomes of mortality and exacerbations, ICS for a year or longer didn’t reduce mortality but decreased exacerbations by 19%.

Clinically significant adverse effects of ICS use included pneumonia, oropharyngeal candidiasis, and bruising; for ICS treatment longer than one year, the numbers needed to harm (NNH) compared with placebo were 30, 27, and 32, respectively. Bone fractures weren’t more common among ICS users. Investigators observed a statistical, but not clinical, QOL benefit as measured by the St. George’s Respiratory Questionnaire (SGRQ) in 5 RCTs with a total of 2507 patients (mean difference, ‒1.22 units/year; 95% confidence interval, ‒1.83 to ‒.60). The minimum clinically important difference on the 76-item questionnaire was 4 units.2

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