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Báo cáo y học: " Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học 'Respiratory Research cung cấp cho các bạn kiến thức về ngành y đề tài:" Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD. | Rennard et al. Respiratory Research 2011 12 18 http respiratory-research.eom content 12 1 18 RESPIRATORY RESEARCH RESEARCH Open Access Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD Cf dr ll- do I Amrrl PrArUi rl rrrlrr 2 I Irlrr It I rtrsd-irir-ir-i3 nirlr Rrrrrlrrrr Idrrllrrrr 3 Rrrrrr r rr r lrr I l l .irtirrov4 Stephen I Rennard Peter MA Calvelley UUU M Goehring Dirk Bredei Ibroker Fernando J Martinez Abstract Background As chronic obstructive pulmonary disease COPD is d heterogeneous disease it is unlikely that dll patients will benefit equally from a given therapy. Roflumilast an oral once-daily phosphodiesterase 4 inhibitor has been shown to improve lung function in moderate and severe COPD but its effect on exacerbations in unselected populations was inconclusive. This led to the question of whether a responsive subset existed that could be investigated further. Methods The datasets of two previous replicate randomized double-blind placebo-controlled parallel-group studies oral roflumilast 500 pg or placebo once daily for 52 weeks that were inconclusive regarding exacerbations were combined in a post-hoc pooled analysis to determine whether roflumilast reduced exacerbations in a more precisely defined patient subset. Results The pooled analysis included 2686 randomized patients. Roflumilast significantly decreased exacerbations by 14.3 compared with placebo p 0.026 . Features associated with this reduction were presence of chronic bronchitis with or without emphysema 26.2 decrease p 0.001 presence of cough 20.9 decrease p 0.006 presence of sputum 17.8 decrease p 0.03 and concurrent use of inhaled corticosteroids ICS 18.8 decrease p 0.014 . The incidence of adverse events was similar with roflumilast and placebo 81.5 vs 80.1 but more patients in the roflumilast group had events assessed as likely or definitely related to the study drug 21.5 vs 8.3 . Conclusions This post-hoc .