title: Meta-analysis of randomized controlled trials of bosentan for treatment of pulmonary arterial hypertension.
abstract: OBJECTIVE
  We assessed the efficacy and safety of bosentan in patients with pulmonary arterial hypertension (PAH).
  
  
  METHODS
  We surveyed randomized controlled trials (RCTs) of the efficacy and safety of bosentan in patients with PAH using MEDLINE, EMBASE, the Cochrane Controlled Trials Register, and manual searches. Meta-analysis of RCTs was performed to determine treatment efficacy and safety outcomes. Results are presented as odds ratios (ORs) or weighted mean differences (WMDs).
  
  
  RESULTS
  Meta-analysis of seven RCTs including a total of 410 patients and 296 controls revealed that the 6-minute work distance was significantly higher in the bosentan group than in the placebo group (WMD, 46.19; 95% confidence interval [CI], 21.20 to 71.19; p = 2.9 × 10(-5)). Compared with the placebo, bosentan significantly reduced the mean pulmonary arterial pressure in patients with PAH (WMD, -6.026; 95% CI, -8.785 to -3.268, p = 1.8 × 10(-6)). The bosentan therapy group worsened less clinically than the placebo group (OR, 0.252; 95% CI, 0.140 to 0.454; p = 4.6 × 10(-7)). The incidence of serious adverse events did not differ between the bosentan and placebo groups (OR, 0.948; 95% CI, 0.556 to 1.614; p = 0.843). However, the results of the abnormal liver function test (LFT) were significantly higher in the bosentan group than in the placebo group (OR, 2.312; 95% CI, 1.020 to 5.241; p = 0.045).
  
  
  CONCLUSIONS
  This meta-analysis shows that bosentan can treat PAH effectively. However, bosentan increased the incidence of abnormal LFT results compared with the placebo.
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
authors.forename: Young Ho
authors.initials: YH
authors.lastname: Lee
authors.forename: Gwan Gyu
authors.initials: GG
authors.lastname: Song
mesh_terms: D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D062186:Arterial Pressure / Q000187:drug effects*; D000077300:Bosentan; D065627:Familial Primary Pulmonary Hypertension; D006801:Humans; D006976:Hypertension, Pulmonary / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008099:Liver / Q000187:drug effects / Q000503:physiopathology; D008111:Liver Function Tests; D016017:Odds Ratio; D011651:Pulmonary Artery / Q000187:drug effects* / Q000503:physiopathology; D012307:Risk Factors; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D013449:Sulfonamides; D000077300:Bosentan
keywords: Bosentan; Efficacy; Hypertension, pulmonary; Safety