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 language | English |
|---|---|
| Pages (from-to) | 701-707 |
| Number of pages | 7 |
| Journal | Korean Journal of Internal Medicine |
| Volume | 28 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 2013 Nov 1 |
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Keywords
- Bosentan
- Efficacy
- Hypertension
- Pulmonary
- Safety
ASJC Scopus subject areas
- Internal Medicine
Cite this
Meta-analysis of randomized controlled trials of bosentan for treatment of pulmonary arterial hypertension. / Lee, Young Ho; Song, Gwan Gyu.
In: Korean Journal of Internal Medicine, Vol. 28, No. 6, 01.11.2013, p. 701-707.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Meta-analysis of randomized controlled trials of bosentan for treatment of pulmonary arterial hypertension
AU - Lee, Young Ho
AU - Song, Gwan Gyu
PY - 2013/11/1
Y1 - 2013/11/1
N2 - 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.
AB - 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.
KW - Bosentan
KW - Efficacy
KW - Hypertension
KW - Pulmonary
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=84891448905&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84891448905&partnerID=8YFLogxK
U2 - 10.3904/kjim.2013.28.6.701
DO - 10.3904/kjim.2013.28.6.701
M3 - Article
VL - 28
SP - 701
EP - 707
JO - Korean Journal of Internal Medicine
JF - Korean Journal of Internal Medicine
SN - 0494-4712
IS - 6
ER -