Korean J Intern Med.  2013 Nov;28(6):701-707. 10.3904/kjim.2013.28.6.701.

Meta-analysis of randomized controlled trials of bosentan for treatment of pulmonary arterial hypertension

• Lee YH
• Song GG

• KMID: 1780131
• DOI: http://doi.org/10.3904/kjim.2013.28.6.701

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.

Keyword

Bosentan; Efficacy; Safety; Hypertension, pulmonary

MeSH Terms

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
Antihypertensive Agents
Sulfonamides