Meta-analysis of randomized controlled trials of bosentan for treatment of pulmonary arterial hypertension.
10.3904/kjim.2013.28.6.701
- Author:
Young Ho LEE
1
;
Gwan Gyu SONG
Author Information
1. Division of Rheumatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. lyhcgh@korea.ac.kr
- Publication Type:Original Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review
- Keywords:
Bosentan;
Efficacy;
Safety;
Hypertension, pulmonary
- MeSH:
Antihypertensive Agents/adverse effects/*therapeutic use;
Arterial Pressure/*drug effects;
Humans;
Hypertension, Pulmonary/diagnosis/*drug therapy/physiopathology;
Liver/drug effects/physiopathology;
Liver Function Tests;
Odds Ratio;
Pulmonary Artery/*drug effects/physiopathology;
Risk Factors;
Sulfonamides/adverse effects/*therapeutic use;
Time Factors;
Treatment Outcome
- From:The Korean Journal of Internal Medicine
2013;28(6):701-707
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND/AIMS: 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 x 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 x 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 x 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.
