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In Reply: Drs Loke and Singh hypothesize that a substantial proportion of the serious adverse events reported in the study by Burge et al¹ may have been COPD exacerbations rather than pneumonia. Lack of explicit definitions of pneumonia may alter the observed association of inhaled corticosteroids with increased pneumonia rates. However, because inhaled corticosteroids reduce COPD exacerbation rates, this form of misclassification would tend to bias estimates of pneumonia risk toward the null, underestimating the actual risk of pneumonia associated with inhaled corticosteroids.

Loke and Singh also suggest that the inclusion of unpublished clinical trial data (GlaxoSmithKline Clinical Trial Register for Burge et al¹ and UK Medicines and Healthcare Regulatory Authority safety newsletter for Calverley et al, 2007²) may refine the estimate of pneumonia risk we reported. Including unpublished data in meta-analyses remains controversial due to the lack of quality control and associated peer review of these data.³

While . . . [Full Text of this Article]

M. Bradley Drummond, MD, MHS
mdrummo3@jhmi.edu

Eddy Fan, MD
Division of Pulmonary and Critical Care Medicine
Johns Hopkins University
Baltimore, Maryland

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