title: Potential treatment benefits and safety of roflumilast in COPD: a systematic review and meta-analysis.
abstract: BACKGROUND
  Current evidence suggests that roflumilast is efficacious in treating COPD, especially in preventing the acute exacerbation of COPD.
  
  
  OBJECTIVE
  This study was designed to evaluate the clinical effects and safety of roflumilast in the treatment of stable COPD using randomized clinical trial (RCT) data.
  
  
  METHODS
  A MEDLINE, EMBASE, and Cochrane Controlled Trials Register search was carried out. RCTs reporting the treatment effects of roflumilast in COPD were identified. Relevant data were extracted and a meta-analysis was performed.
  
  
  RESULTS
  A total of nine articles and 13 RCT studies were identified. Overall, 29.1% of the subjects in the roflumilast group showed evidence of exacerbation. The corresponding figure was 32.2% in the placebo group. According to pooled analysis, the use of roflumilast reduced COPD exacerbations in comparison to placebo (odds ratio [OR] =0.82, 95% confidence interval [CI] =0.75-0.9). The quality of life and spirometry were improved. For patients receiving baseline pre-bronchodilators, their average forced expiratory volume in the first second showed evidence of change when they took roflumilast (64.88 mL; 95% CI =54.09-75.66). Those who took placebo showed no evidence of change. Similar result was observed in patients receiving baseline (54.49 mL; 95% CI =44.04-64.94). As for the safety of roflumilast treatment, the overall cumulative incidence of adverse drug reaction was 54.2% in the roflumilast group and 48.2% in the placebo group (OR =1.36, 95% CI =1.13-1.65). The adverse effects included diarrhea, headache, nausea, weight loss, and insomnia.
  
  
  CONCLUSIONS
  The efficacy of roflumilast in the prevention of acute exacerbation of COPD is obvious. Roflumilast is proved to be able to improve spirometry of COPD patients. The adverse drug reaction did not increase significantly in the roflumilast group compared with the control group. COPD patients can benefit from roflumilast therapy. However, our results are limited by the cohort design of the selected studies and the degree of heterogeneity among them; hence, more randomized trials are needed to further support this conclusion.
authors.affiliation: Department of Respiration, Tianjin Hospital of ITCWM (Tianjin Nankai Hospital).
authors.forename: Lianfang
authors.initials: L
authors.lastname: Yuan
authors.affiliation: Department of Respiration, Tianjin Hospital of ITCWM (Tianjin Nankai Hospital).
authors.forename: Xuan
authors.initials: X
authors.lastname: Dai
authors.affiliation: Department of Pharmacy, Tianjin Medical University Cancer Institute and Hospital, Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China.
authors.forename: Meng
authors.initials: M
authors.lastname: Yang
authors.affiliation: Department of Respiration, Tianjin Hospital of ITCWM (Tianjin Nankai Hospital).
authors.forename: Qiling
authors.initials: Q
authors.lastname: Cai
authors.affiliation: Department of Respiration, Tianjin Hospital of ITCWM (Tianjin Nankai Hospital).
authors.forename: Na
authors.initials: N
authors.lastname: Shao
mesh_terms: D000631:Aminopyridines / Q000009:adverse effects / Q000627:therapeutic use*; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003521:Cyclopropanes / Q000009:adverse effects / Q000627:therapeutic use; D018450:Disease Progression; D005541:Forced Expiratory Volume; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D016017:Odds Ratio; D058988:Phosphodiesterase 4 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D020127:Recovery of Function; D012720:Severity of Illness Index; D013147:Spirometry; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D003521:Cyclopropanes; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast
keywords: COPD; adverse drug reaction; efficacy; meta-analysis; roflumilast; spirometry