Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension

Autor: Dong Bao Zhao, Da Xin Zhou, Jie Yan Shen, Xian Sheng Cheng, Zhi-Cheng Jing, Hua Yao, Xin Pan, Hong Gu, Xian Yang Zhu, Zhuoli Zhang, Yong Wang, Geoff Strange, Mei Xiang Xiang, Yue Jin Yang, Brad Dalton, Zhen Kun Yang
Rok vydání: 2010
Předmět:
Zdroj: The Journal of Heart and Lung Transplantation. 29:150-156
ISSN: 1053-2498
DOI: 10.1016/j.healun.2009.09.020
Popis: 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.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 weighed40 kg received 62.5 mg bosentan twice daily and patients who weighed40 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.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 (p0.001). After 24 weeks, WHO functional class decreased (-0.8 +/- 0.6; p0.001), mean pulmonary artery pressure and pulmonary vascular resistance decreased (p0.01), and cardiac output increased (p0.001). Twelve patients (13%) experienced at least 1 adverse event.Bosentan improved exercise capacity, functional class, and cardiopulmonary hemodynamics in this patient cohort and was well tolerated.
Databáze: OpenAIRE