Document Detail

Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension.
MedLine Citation:
PMID:  20113907     Owner:  NLM     Status:  MEDLINE    
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.
Zhi-Cheng Jing; Geoff Strange; Xian-Yang Zhu; Da-Xin Zhou; Jie-Yan Shen; Hong Gu; Zhen-Kun Yang; Xin Pan; Mei-Xiang Xiang; Hua Yao; Dong-Bao Zhao; Brad S Dalton; Zhuo-Li Zhang; Yong Wang; Xian-Sheng Cheng; Yue-Jin Yang
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation     Volume:  29     ISSN:  1557-3117     ISO Abbreviation:  J. Heart Lung Transplant.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-01     Completed Date:  2010-05-27     Revised Date:  2013-06-18    
Medline Journal Info:
Nlm Unique ID:  9102703     Medline TA:  J Heart Lung Transplant     Country:  United States    
Other Details:
Languages:  eng     Pagination:  150-6     Citation Subset:  IM    
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. <>
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MeSH Terms
Antihypertensive Agents / administration & dosage*
Hypertension, Pulmonary / drug therapy*
Severity of Illness Index
Sulfonamides / administration & dosage*
Treatment Outcome
Reg. No./Substance:
0/Antihypertensive Agents; 0/Sulfonamides; Q326023R30/bosentan
Comment In:
J Heart Lung Transplant. 2010 Feb;29(2):157-8   [PMID:  20113908 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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