title: Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension.
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.
authors.affiliation: Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. jingzhicheng@gmail.com <jingzhicheng@gmail.com>
authors.forename: Zhi-Cheng
authors.initials: ZC
authors.lastname: Jing
authors.forename: Geoff
authors.initials: G
authors.lastname: Strange
authors.forename: Xian-Yang
authors.initials: XY
authors.lastname: Zhu
authors.forename: Da-Xin
authors.initials: DX
authors.lastname: Zhou
authors.forename: Jie-Yan
authors.initials: JY
authors.lastname: Shen
authors.forename: Hong
authors.initials: H
authors.lastname: Gu
authors.forename: Zhen-Kun
authors.initials: ZK
authors.lastname: Yang
authors.forename: Xin
authors.initials: X
authors.lastname: Pan
authors.forename: Mei-Xiang
authors.initials: MX
authors.lastname: Xiang
authors.forename: Hua
authors.initials: H
authors.lastname: Yao
authors.forename: Dong-Bao
authors.initials: DB
authors.lastname: Zhao
authors.forename: Brad S
authors.initials: BS
authors.lastname: Dalton
authors.forename: Zhuo-Li
authors.initials: ZL
authors.lastname: Zhang
authors.forename: Yong
authors.initials: Y
authors.lastname: Wang
authors.forename: Xian-Sheng
authors.initials: XS
authors.lastname: Cheng
authors.forename: Yue-Jin
authors.initials: YJ
authors.lastname: Yang
mesh_terms: 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
chemical_list: D000959:Antihypertensive Agents; D013449:Sulfonamides; D000077300:Bosentan