RT Journal Article
SR Electronic
T1 Roflumilast for stable COPD: Meta-analysis of randomized controlled trials
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3572
VO 44
IS Suppl 58
A1 Huihui Zeng
A1 Yan Chen
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P3572.abstract
AB Backgroud:This work evaluats the effectiveness of roflumilast, a phosphodiesterase 4 inhibitor, in stable COPD management.Methods: MEDLINE, EMBASE, the Cochrane database, CINAHL, and ClinicalTrials.gov were searched to Dec 2013. Missing data were obtained from authors and manufacturers. Studies were pooled to yield relative risk (RR), odds ratios (OR), weighted mean differences with 95% confidence intervals (CI) with the I2statistic. A fixed-effects model (I2<50%) was applied.Results: Ten eligible randomized controlled trials (9574 patients, Jadad score 3) were included. Roflumilast significantly improved pre-bronchodilator(BD) FEV1 (WMD 55.25ml; 95%CI 46.6 to 63.87; p=0.000;I2=39.0%), post-BD FEV1 (59.92ml; 51.20 to 68.63; p=0.000; I2=15.5%), and post-BD FVC (58.3ml; 43.7 to 72.9; p=0.000; I2=0.0%). The improvement on lung function was greater in Asian population than other population. Roflumilast was associated with prolonged median time to first exacerbation (HR: 0.86; 95%CI: 0.78 to 0.95; p=0.02; I2=13.9%) and reduction in exacerbations (RR:0.85; 95%CI: 0.79 to 0.91; p=0.000; I2=0.0%). The improvement in SGRQ score or transition dyspnea index score was statistically but not clinically significant (WMD:-1.57;95%CI -2.49 to -0.65; p=0.001; I2=47.0%, and 0.27;0.14 to 0.39; p=0.000;I2=29.9%, respectively). Roflumilast did not affect all-cause mortality, but increased some adverse events including diarrhea, nausea, and weight loss. Weight loss was most evident in obese patients (BMI>30).Conclusion:Roflumilast improved lung function and reduce mean exacerbation rate in stable COPD patients with a high risk of adverse events and variaty in different COPD phenotypes.