Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension
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Jing, ZC and Strange, G and Zhu, XY and Zhou, DX and Shen, JY and Gu, H and Yang, ZK and Pan, X and Xiang, MX and Yao, H and Zhao, DB and Dalton, BS and Zhang, ZL and Wang, Y and Chen, XS and Yang, YJ, Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension, The Journal of Heart and Lung Transplantation, 29, (2) pp. 150-156. ISSN 1053-2498 (2010) [Refereed Article]
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. © 2010 International Society for Heart and Lung Transplantation.
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