title: [Sildenafil therapy for pulmonary hypertension: a prospective study].
abstract: OBJECTIVE
  To explore the safety and efficacy of oral sildenafil therapy for pulmonary arterial hypertension (PAH), and to provide evidence for sildenafil treatment for Chinese patients with PAH.
  
  
  METHODS
  In this 12-week, prospective, open-label, uncontrolled study, 56 patients with PAH were given oral sildenafil (25 mg, tid). The primary end point was change from baseline to 12 weeks in exercise capacity assessed by 6 min walk (6MW) test. Secondary end points included changes in WHO class and cardiopulmonary hemodynamics. Clinical worsening was defined as death, transplantation, hospitalization for PAH, or initiation of additional therapies for PAH, such as intravenous epoprostenol or oral bosentan.
  
  
  RESULTS
  After 12 weeks, the compliance was good in 56 patients. Significant improvement was seen in NYHA heart function class and WHO class as compared to baseline (P < 0.01): from class IV to class III in 2, from class III to class II in 8 and to class I in 2 cases, and from class II to class I in 5 cases. No NYHA heart function class and WHO PAH function class deterioration were observed. Oral sildenafil increased 6MW distance, from (352 ± 80) m to (396 ± 78) m, with a change of (44 ± 70) m (P < 0.01). Significant improvement was seen in hemodynamics (mean pulmonary artery pressure, P < 0.01; cardiac index, P < 0.01; pulmonary vascular resistance, P < 0.01) at week 12 as compared with baseline. Mean right atrial pressure decreased (3 ± 11) mm Hg (1 mm Hg = 0.133 kPa), mean pulmonary arterial pressure decreased (6 ± 14) mm Hg, cardiac output increased (1.1 ± 2.0) L/min, cardiac index increased (0.7 ± 1.1) L×min(-1)×m(-2), and total pulmonary resistance decreased (490 ± 831) Dys×s×cm(-5). Side effects were mild and consistent with those reported with sildenafil treatment. No statistically significant clinical worsening was observed with sildenafil therapy for PAH patients.
  
  
  CONCLUSIONS
  Sildenafil improves exercise capacity, WHO functional class, and hemodynamics in patients with pulmonary arterial hypertension.
authors.affiliation: Center for Diagnosis and Management of Pulmonary Vascular Diseases, Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.
authors.forename: Xian-ling
authors.initials: XL
authors.lastname: Lu
authors.forename: Chang-ming
authors.initials: CM
authors.lastname: Xiong
authors.forename: Guang-liang
authors.initials: GL
authors.lastname: Shan
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: Wei-jie
authors.initials: WJ
authors.lastname: Zeng
authors.forename: Feng
authors.initials: F
authors.lastname: Zhu
authors.forename: Jian-Guo
authors.initials: JG
authors.lastname: He
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004361:Drug Tolerance; D065627:Familial Primary Pulmonary Hypertension; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use*; D011446:Prospective Studies; D011687:Purines / Q000009:adverse effects / Q000627:therapeutic use; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000009:adverse effects* / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate