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April 8, 2009

Inhaled Corticosteroids in Patients With Chronic Obstructive Pulmonary Disease

JAMA. 2009;301(14):1432-1434. doi:10.1001/jama.2009.435

To the Editor: We are concerned about possible data discrepancies in the systematic review and meta-analysis of inhaled corticosteroids in patients with stable chronic obstructive pulmonary disease (COPD) by Dr Drummond and colleagues.1 In the analysis of pneumonia events from the study by Burge et al,2 Drummond et al reported 87 of 372 events in the inhaled corticosteroid group vs 101 of 370 events in the control group, reflecting a control event rate that is considerably higher than any other trial in the meta-analysis. However, the trial publication2 actually reports on “lower respiratory serious adverse events” rather than pneumonia events. The company trial report from the GlaxoSmithKline Clinical Trial Register (FLTB3054, the identification number for the study by Burge et al) shows that there were only 18 and 8 pneumonia events in the fluticasone and control groups, respectively.3 We believe that a substantial proportion of the lower respiratory serious adverse events data in the trial publication were actually COPD exacerbations.

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