1. Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension
- Author
-
Jing, Zhi-Cheng, Strange, Geoff, Zhu, Xian-Yang, Zhou, Da-Xin, Shen, Jie-Yan, Gu, Hong, Yang, Zhen-Kun, Pan, Xin, Xiang, Mei-Xiang, Yao, Hua, Zhao, Dong-Bao, Dalton, Brad S., Zhang, Zhuo-Li, Wang, Yong, Cheng, Xian-Sheng, and Yang, Yue-Jin
- Subjects
- *
PULMONARY hypertension treatment , *CHINESE people , *DISEASE management , *HYPERTENSION , *PATIENTS , *HEART disease genetics , *CARDIOPULMONARY system , *DRUG efficacy , *DISEASES - Abstract
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. [Copyright &y& Elsevier]
- Published
- 2010
- Full Text
- View/download PDF