Title Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension
Authors 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
Yang, Yue-Jin
Affiliation Tongji Univ, Dept Pulm Circulat, Shanghai Pulm Hosp, Sch Med, Shanghai 200092, Peoples R China.
Monash Univ, Clayton, Vic 3800, Australia.
Gen Hosp Shenyang Mil Command, Dept Congenital Heart Dis, Shenyang, Peoples R China.
Fudan Univ, Dept Cardiol, Zhongshan Hosp, Shanghai 200433, Peoples R China.
Shanghai Jiao Tong Univ, Dept Cardiol, Renji Hosp, Sch Med, Shanghai 200030, Peoples R China.
Capital Univ Med Sci, Dept Pediat, Beijing Anzhen Hosp, Beijing, Peoples R China.
Ruijin Hosp, Dept Cardiol, Shanghai, Peoples R China.
Shanghai Jiao Tong Univ, Dept Cardiol, Shanghai Chest Hosp, Sch Med, Shanghai 200030, Peoples R China.
Zhejiang Univ, Dept Cardiol, Affiliated Hosp 2, Coll Med, Hangzhou 310003, Zhejiang, Peoples R China.
Guangzhou Gen Hosp, Dept Cardiol, Guangzhou, Guangdong, Peoples R China.
Second Mil Med Univ, Dept Rheumatol, Changhai Hosp, Shanghai, Peoples R China.
Univ Tasmania, Sch Human Life Sci, Hobart, Tas 7001, Australia.
Beijing Univ, Dept Rheumatol, Hosp 1, Beijing 100871, Peoples R China.
Beijing Shijitan Hosp, Dept Pulm Vasc Dis, Beijing, Peoples R China.
Beijing Fu Wai Hosp, Dept Cardiol, Beijing, Peoples R China.
Keywords pulmonary arterial hypertension
bosentan
CONGENITAL HEART-DISEASE
RECEPTOR ANTAGONIST BOSENTAN
EISENMENGER-SYNDROME
EXERCISE CAPACITY
1ST-LINE BOSENTAN
THERAPY
SURVIVAL
REGISTRY
ADULTS
MANAGEMENT
Issue Date 2010
Citation JOURNAL OF HEART AND LUNG TRANSPLANTATION.2010,29,(2,SI),150-156.
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 chance 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), ana 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. J Heart Lung Transplant 2010;29:150-6 (C) 2010 International Society for Heart and Lung Transplantation. All rights reserved.
URI http://hdl.handle.net/20.500.11897/401309
ISSN 1053-2498
DOI 10.1016/j.healun.2009.09.020
Indexed SCI(E)
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