title: [Preliminary study on the efficacy and safety of oral sildenafil in pulmonary arterial hypertension in China].
abstract: 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.
  
  
  CONCLUSIONS
  This study confirms and extends previous studies. Oral sildenafil is both safe and effective for the treatment of adult PAH patients in China.
authors.affiliation: Center for Diagnosis and Management of Pulmonary Vascular Diseases, Department of Cardiology, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.
authors.forename: Chang-Ming
authors.initials: CM
authors.lastname: Xiong
authors.forename: Jian-Guo
authors.initials: JG
authors.lastname: He
authors.forename: Xian-Ling
authors.initials: XL
authors.lastname: Lu
authors.forename: Guang-Liang
authors.initials: GL
authors.lastname: Shan
authors.forename: Bing-Xiang
authors.initials: BX
authors.lastname: Wu
authors.forename: Xian-Yang
authors.initials: XY
authors.lastname: Zhu
authors.forename: Guang-Hua
authors.initials: GH
authors.lastname: Wu
authors.forename: Xiao-Feng
authors.initials: XF
authors.lastname: Zeng
authors.forename: Tao
authors.initials: T
authors.lastname: Guo
authors.forename: Zhi-Hong
authors.initials: ZH
authors.lastname: Liu
authors.forename: Xin-Hai
authors.initials: XH
authors.lastname: Ni
authors.forename: Xian-Sheng
authors.initials: XS
authors.lastname: Cheng
authors.forename: Qing
authors.initials: Q
authors.lastname: Gu
authors.forename: Zhi-Hui
authors.initials: ZH
authors.lastname: Zhao
authors.forename: Hong-Yan
authors.initials: HY
authors.lastname: Tian
authors.forename: Wei-Min
authors.initials: WM
authors.lastname: Li
authors.forename: Duan-Zhen
authors.initials: DZ
authors.lastname: Zhang
authors.forename: Cheng
authors.initials: C
authors.lastname: Zhang
authors.forename: Meng-Tao
authors.initials: MT
authors.lastname: Li
authors.forename: Hong-Ming
authors.initials: HM
authors.lastname: Liu
authors.forename: Ya-Juan
authors.initials: YJ
authors.lastname: Guo
authors.forename: Jie-Yan
authors.initials: JY
authors.lastname: Shen
authors.forename: Wei-Jun
authors.initials: WJ
authors.lastname: Zhang
authors.forename: Shuang
authors.initials: S
authors.lastname: Liu
authors.forename: Da-Xin
authors.initials: DX
authors.lastname: Zhou
authors.forename: Chun-de
authors.initials: CD
authors.lastname: Bao
authors.forename: Shi-An
authors.initials: SA
authors.lastname: Huang
authors.forename: Jian-Ying
authors.initials: JY
authors.lastname: Chen
authors.forename: Wei-Feng
authors.initials: WF
authors.lastname: Wu
authors.forename: Kai
authors.initials: K
authors.lastname: Huang
authors.forename: Chang-Ling
authors.initials: CL
authors.lastname: Li
authors.forename: Li-Hua
authors.initials: LH
authors.lastname: Wang
authors.forename: Bei
authors.initials: B
authors.lastname: He
mesh_terms: D000293:Adolescent; D000328:Adult; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005080:Exercise Test; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011687:Purines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate