JOURNAL ARTICLE
MULTICENTER STUDY

[Preliminary study on the efficacy and safety of oral sildenafil in pulmonary arterial hypertension in China]

Chang-Ming Xiong, Jian-Guo He, Xian-Ling Lu, Guang-Liang Shan, Bing-Xiang Wu, Xian-Yang Zhu, Guang-Hua Wu, Xiao-Feng Zeng, Tao Guo, Zhi-Hong Liu, Xin-Hai Ni, Xian-Sheng Cheng, Qing Gu, Zhi-Hui Zhao, Hong-Yan Tian, Wei-Min Li, Duan-Zhen Zhang, Cheng Zhang, Meng-Tao Li, Hong-Ming Liu, Ya-Juan Guo, Jie-Yan Shen, Wei-Jun Zhang, Shuang Liu, Da-Xin Zhou, Chun-de Bao, Shi-An Huang, Jian-Ying Chen, Wei-Feng Wu, Kai Huang, Chang-Ling Li, Li-Hua Wang, Bei He
Zhonghua Yi Xue za Zhi [Chinese medical journal] 2011 February 15, 91 (6): 370-4
21418907

OBJECTIVE: Sildenafil has been shown to be effective in pulmonary arterial hypertension (PAH). However, the impact of sildenafil on PAH has been under-investigated in China. The aim of the present study was to evaluate the efficacy and safety of oral sildenafil in PAH patients in China.

METHODS: In this prospective, open-label and multi-center study, 90 patients were recruited from 14 centers to receive oral sildenafil (75 mg/d) for 12 weeks. They underwent a six-minute walk test (SMWT) and cardiac catheterization at the beginning and the end of 12 weeks. The primary endpoint was the changes in exercise capacity as assessed by SMWT. And the secondary endpoints included assessment of functional class, evaluation of cardiopulmonary hemodynamics and clinical deterioration (defined as death, transplantation and re-hospitalization for PAH). Drug safety and tolerability were also examined.

RESULTS: There were 19 males and 71 females with an average age of 32.5 ± 12.1 years old (range: 18 - 61). Their etiologies were idiopathic (n = 15), related with congenital heart disease (n = 60), or related with connective tissue disease (n = 9) and chronic thromboembolic pulmonary hypertension (n = 6). Oral sildenafil significantly increased the SMWT distances [(342 ± 93) m vs. (403 ± 88) m, P < 0.001]. There was also remarkable improvement in Borg dyspnea score (2.9 ± 2.6 vs. 2.4 ± 2.0, P = 0.005). Furthermore, significant improvements in World Healthy Organization (WHO) functional class and cardiopulmonary hemodynamics were also found (mean pulmonary artery pressure, P < 0.001; cardiac index, P < 0.001; pulmonary vascular resistance, P < 0.001). Side effects were mild and consistent with other reports.

CONCLUSION: This study confirms and extends previous studies. Oral sildenafil is both safe and effective for the treatment of adult PAH patients in China.

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