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BackgroundEffects of roflumilast on lung function, symptoms, acute exacerbation and adverse events in patients with chronic obstructive pulmonary disease (COPD) are controversial. We aimed to further clarify the efficacy and safety of roflumilast in treatment of moderate-to-severe COPD.MethodsFrom 1946 to November 2015, we searched the Pubmed, Embase, Medline, Cochrane Central Register of Controlled Trials, ISI Web of Science and American College of Physician using "roflumilast" and "chronic obstructive pulmonary disease" or "COPD". Randomized controlled trials that reported forced expiratory volume in one second (FEV1), forced vital capacity (FVC), transition dyspnea index (TDI), St George's Respiratory Questionnaire (SGRQ), and incidence of COPD exacerbations and adverse events were eligible. We conducted the heterogeneities test and sensitivity analysis, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference (MD) for dichotomous and continuous data respectively. Cochrane systematic review software, Review Manager (RevMan), was used to test the hypothesis by Mann-Whitney U-test.ResultsThirteen trials with a total of 14,563 patients were pooled in our final studies. Except for SGRQ (I (2) = 63 %, χ (2) = 1.71, P = 0.07) and adverse events (I (2) = 94 %, χ (2) = 0.03, P ConclusionsRoflumilast can be considered as an alternative therapy in selective patients with moderate-to-severe COPD.

Original publication




Journal article


Respiratory research

Publication Date





Department of Respiratory and Critical Care Medicine, Sichuan University, Chengdu, China.


Humans, Pulmonary Disease, Chronic Obstructive, Benzamides, Aminopyridines, Cyclopropanes, Respiratory Function Tests, Treatment Outcome, Severity of Illness Index, Prevalence, Risk Factors, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Phosphodiesterase 4 Inhibitors