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Efficacy and Safety of Inhaled Corticosteroids in Patients With COPD: A Systematic Review and Meta-Analysis of Health Outcomes

¹ Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC
² Division of Pharmaceutical Policy and Evaluative Sciences, School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC
³ Division of Pulmonary and Critical Care Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC
⁴ Department of Health Policy & Administration, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC

CORRESPONDING AUTHOR: Gerald Gartlehner, MD, MPH, Cecil G. Sheps Center for Health Services Research University of North Carolina at Chapel Hill, 725 Airport Road, Chapel Hill, NC 27599, gartlehner{at}schsr.unc.edu

PURPOSE We wanted to review systematically the efficacy, effectiveness, and safety of inhaled corticosteroids with respect to health outcomes in patients with chronic obstructive pulmonary disease (COPD).

METHODS We searched MEDLINE, EMBASE, The Cochrane Library, and the International Pharmaceutical Abstracts to identify relevant articles. We limited evidence to double-blinded randomized controlled trials (RCTs) for efficacy, but we also reviewed observational evidence for safety. Outcomes of interest were overall mortality, exacerbations, quality of life, functional capacity, and respiratory tract symptoms. When possible, we pooled data to estimate summary effects for each outcome.

RESULTS Thirteen double-blinded RCTs determined the efficacy of an inhaled corticosteroid compared with placebo; 11 additional studies assessed the safety of inhaled corticosteroid treatment in patients with asthma or COPD. Overall, COPD patients treated with inhaled corticosteroids experienced significantly fewer exacerbations than patients taking placebo (relative risk [RR] = 0.67; 95% CI, 0.59–0.77). No significant difference could be detected for overall mortality (RR = 0.81; 95% CI, 0.60–1.08). Evidence on quality of life, functional capacity, and respiratory tract symptoms is mixed. Adverse events were generally tolerable; pooled discontinuation rates did not differ significantly between inhaled corticosteroid and placebo treatment groups (RR = 0.92; 95% CI, 0.74–1.14). Observational evidence, however, indicates a dose-related risk of cataract and open-angle glaucoma. Severe adverse events, such as osteoporotic fractures, are rare; the clinical importance of the additional risk is questionable.

CONCLUSIONS Overall, the risk-benefit ratio appears to favor inhaled corticosteroid treatment in patients with moderate to severe COPD. Existing evidence does not indicate a treatment benefit for patients with mild COPD.

Key Words: Chronic obstructive pulmonary disease/drug therapy • corticosteroids • health outcomes • systematic review • meta-analysis

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