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

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• 作者：Nicola A. Hanania ; Peter M.A. Calverley ; Mark T. Dransfield ; Jill P. Karpel ; Manja Brose ; Haiyuan Zhu ; Udo-Michael Goehring ; Paul Rowe
• 关键词：Chronic obstructive pulmonary disease ; Roflumilast ; Inhaled corticosteroids ; Long-acting 尾2-agonists ; Exacerbation ; Lung function
• 刊名：Respiratory Medicine
• 出版年：February, 2014
• 年：2014
• 卷：108
• 期：2
• 页码：366-375
• 全文大小：1101 K

文摘

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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 尾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聽渭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聽=聽3091), addition of roflumilast to LABAs for 1 year in patients who discontinued ICS prior to study entry (n聽=聽945) significantly reduced the risk of COPD exacerbations vs. placebo by 19.2% (p聽<聽0.05) and significantly improved pre- and postbronchodilator FEV₁ by 40聽mL and 34聽mL, respectively (both, p聽<聽0.01). Similar improvements were observed in patients who received concomitant LABAs but were not taking ICS prior to study entry (n聽=聽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聽<聽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

(M2-124) and (M2-125).