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

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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 × 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.

Original languageEnglish
Pages (from-to)701-707
Number of pages7
JournalKorean Journal of Internal Medicine
Volume28
Issue number6
DOIs
Publication statusPublished - 2013 Nov 1

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Pulmonary Hypertension
Meta-Analysis
Randomized Controlled Trials
Placebos
Confidence Intervals
Odds Ratio
Therapeutics
Liver Function Tests
Safety
bosentan
Incidence
Group Psychotherapy
MEDLINE
Arterial Pressure
Lung

Keywords

  • Bosentan
  • Efficacy
  • Hypertension
  • Pulmonary
  • Safety

ASJC Scopus subject areas

  • Internal Medicine

Cite this

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title = "Meta-analysis of randomized controlled trials of bosentan for treatment of pulmonary arterial hypertension",
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 × 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.",
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