Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension.
BACKGROUND
Bosentan has an established role in the management of pulmonary arterial hypertension (PAH). This clinical trial assessed the benefits of bosentan in the Chinese population.


METHODS
We investigated the efficacy and safety of bosentan in 92 Chinese citizens (mean +/- standard deviation age, 29.0 +/- 3.8 years) with PAH for a minimum of 12 weeks. All received bosentan (62.5 mg twice daily) for 4 weeks; then, patients who weighed <40 kg received 62.5 mg bosentan twice daily and patients who weighed >40 kg received 125 mg twice daily. All patients were eligible to continue bosentan beyond 12 weeks. The primary end point was a change in exercise capacity from baseline to 12 and 24 weeks. Secondary end points included a change in World Health Organization (WHO) functional class and changes in cardiopulmonary hemodynamics.


RESULTS
At baseline, 66 patients (72%) were in WHO functional class III; presentation was 37 (40%) with idiopathic PAH (iPAH), 34 (37%) with PAH related to congenital heart disease (CHD), and 21 (23%) with PAH related to connective tissue disease (CTD). Exercise capacity increased to 67.8 m after 12 weeks and 92.6 m after 24 weeks (p < 0.001). After 24 weeks, WHO functional class decreased (-0.8 +/- 0.6; p < 0.001), mean pulmonary artery pressure and pulmonary vascular resistance decreased (p < 0.01), and cardiac output increased (p < 0.001). Twelve patients (13%) experienced at least 1 adverse event.


CONCLUSIONS
Bosentan improved exercise capacity, functional class, and cardiopulmonary hemodynamics in this patient cohort and was well tolerated.
Jing
Zhi-Cheng
ZC
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. jingzhicheng@gmail.com <jingzhicheng@gmail.com>
Strange
Geoff
G
Zhu
Xian-Yang
XY
Zhou
Da-Xin
DX
Shen
Jie-Yan
JY
Gu
Hong
H
Yang
Zhen-Kun
ZK
Pan
Xin
X
Xiang
Mei-Xiang
MX
Yao
Hua
H
Zhao
Dong-Bao
DB
Dalton
Brad S
BS
Zhang
Zhuo-Li
ZL
Wang
Yong
Y
Cheng
Xian-Sheng
XS
Yang
Yue-Jin
YJ
D000328:Adult; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D000077300:Bosentan; D002681:China; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D008297:Male; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000008:administration & dosage*; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D013449:Sulfonamides; D000077300:Bosentan