Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD.

Background: This post-hoc analysis examined the impact of roflumilast on chronic obstructive pulmonary disease (COPD) exacerbations and lung function in patients with COPD who received concomitant long-acting beta(2)-agonists (LABA) with or without prior inhaled corticosteroid (ICS) and the influence of various demographic and clinical characteristics on these outcomes. Methods: Data were pooled from 2 double-blind, placebo-controlled, 52-week studies of once-daily roflumilast 500 mu g in patients with COPD. Endpoints were mean rate of exacerbations and change from baseline in pre- and postbronchodilator FEV1. Results: In this pooled analysis (N = 3091), addition of roflumilast to LABAs for 1 year in patients who discontinued ICS prior to study entry (n = 945) significantly reduced the risk of COPD exacerbations vs. placebo by 19.2% (p < 0.05) and significantly improved pre- and postbronchodilator FEV1 by 40 mL and 34 mL, respectively (both, p < 0.01). Similar improvements were observed in patients who received concomitant LABAs but were not taking ICS prior to study entry (n = 597). A significant reduction in COPD exacerbation risk with roflumilast vs. placebo was observed regardless of age or smoking status, and in patients who had severe or very severe COPD. Significantly improved lung function was observed with roflumilast in all the subgroups (p < 0.05), with the exception of patients with moderate COPD. Conclusions: Roflumilast reduced exacerbation rates and improved lung function in patients with COPD who received concomitant LABA, regardless of. prior ICS use, and across various patient subgroups regardless of age and smoking status. ClinicalTrials.gov registration numbers: NCT00297102 (M2-124) and NCT00297115 (M2-125). (C) 2013 Published by Elsevier Ltd.