title: Vardenafil in pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  Although the phosphodiesterase type 5 inhibitors sildenafil and tadalafil have demonstrated efficacy in patients with pulmonary arterial hypertension (PAH), monotherapy with these agents has not been conclusively shown to reduce clinical worsening events.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of the phosphodiesterase type 5 inhibitor vardenafil in Chinese patients with PAH.
  
  
  METHODS
  In a randomized, double-blind, placebo-controlled study, 66 patients with PAH were randomized 2:1 to vardenafil (5 mg once daily for 4 wk then 5 mg twice daily; n = 44) or placebo (n = 22) for 12 weeks. Patients completing this phase were then treated with open-label vardenafil (5 mg twice daily) for a further 12 weeks.
  
  
  RESULTS
  At Week 12, the mean placebo-corrected 6-minute walking distance was increased with vardenafil (69 m; P < 0.001), and this improvement was maintained for at least 24 weeks. Vardenafil also increased the mean placebo-corrected cardiac index (0.39 L·min(-1)·m(-2); P = 0.005) and decreased mean pulmonary arterial pressure and pulmonary vascular resistance (-5.3 mm Hg, P = 0.047; -4.7 Wood U, P = 0.003; respectively) at Week 12. Four patients in the placebo group (20%) and one in the vardenafil group (2.3%) had clinical worsening events (hazard ratio 0.105; 95% confidence interval, 0.012-0.938; P = 0.044). Vardenafil was associated with only mild and transient adverse events.
  
  
  CONCLUSIONS
  Vardenafil is effective and well tolerated in patients with PAH at a dose of 5 mg twice daily.
authors.affiliation: Department of Cardio-Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, 507 Zhengmin Road, Shanghai 200433, China. jingzhicheng@gmail.com
authors.forename: Zhi-Cheng
authors.initials: ZC
authors.lastname: Jing
authors.forename: Zai-Xin
authors.initials: ZX
authors.lastname: Yu
authors.forename: Jie-Yan
authors.initials: JY
authors.lastname: Shen
authors.forename: Bing-Xiang
authors.initials: BX
authors.lastname: Wu
authors.forename: Kai-Feng
authors.initials: KF
authors.lastname: Xu
authors.forename: Xian-Yang
authors.initials: XY
authors.lastname: Zhu
authors.forename: Lei
authors.initials: L
authors.lastname: Pan
authors.forename: Zhuo-Li
authors.initials: ZL
authors.lastname: Zhang
authors.forename: Xue-Qin
authors.initials: XQ
authors.lastname: Liu
authors.forename: Yu-Shun
authors.initials: YS
authors.lastname: Zhang
authors.forename: Xin
authors.initials: X
authors.lastname: Jiang
authors.forename: Nazzareno
authors.initials: N
authors.lastname: Galiè
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006321:Heart; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000503:physiopathology; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011311:Pressoreceptors / Q000187:drug effects; D011652:Pulmonary Circulation / Q000187:drug effects; D013450:Sulfones / Q000627:therapeutic use; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride; D014655:Vascular Resistance / Q000187:drug effects; D014665:Vasodilator Agents / Q000627:therapeutic use*; D016138:Walking
chemical_list: D007093:Imidazoles; D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D014665:Vasodilator Agents; D000069058:Vardenafil Dihydrochloride