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

Summary 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 β2 -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 μg 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