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学科主题: 临床医学
题名:
Vardenafil in Pulmonary Arterial Hypertension A Randomized, Double-blind, Placebo-controlled Study
作者: Jing, Zhi-Cheng1; Yu, Zai-Xin2; Shen, Jie-Yan3; Wu, Bing-Xiang4; Xu, Kai-Feng5; Zhu, Xian-Yang6; Pan, Lei7; Zhang, Zhuo-Li8; Liu, Xue-Qin8; Zhang, Yu-Shun9; Jiang, Xin1; Galie, Nazzareno10; Efficacy Safety Vardenafil Treatme
关键词: pulmonary hypertension ; phosphodiesterase inhibitors ; vardenafil ; exercise ; hemodynamics
刊名: AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
发表日期: 2011-06-15
DOI: 10.1164/rccm.201101-0093OC
卷: 183, 期:12, 页:1723-1729
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Critical Care Medicine ; Respiratory System
研究领域[WOS]: General & Internal Medicine ; Respiratory System
关键词[WOS]: NITRIC-OXIDE ; SILDENAFIL ; INHIBITORS ; THERAPY ; TRIAL ; MULTICENTER ; DISEASE ; CELLS ; PDE5
英文摘要:

Rationale: 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.

Objectives: 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 4wk then 5mg twice daily; n 44) or placebo (n = 22) for 12 weeks. Patients completing this phase were then treated with openlabel vardenafil (5 mg twice daily) for a further 12 weeks.

Measurements and Main Results: At Week 12, the mean placebocorrected 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.

语种: 英语
所属项目编号: 08PJ14086
项目资助者: Shanghai Pujiang Program ; Actelion ; Bayer Schering ; Pfizer ; United Therapeutics ; GlaxoSmithKline ; Eli Lilly ; Bayer
WOS记录号: WOS:000292305600025
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/67067
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.Tongji Univ, Sch Med, Shanghai Pulm Hosp, Dept Cardiopulm Circulat, Shanghai 200433, Peoples R China
2.Cent S Univ, Xiangya Hosp, Dept Cardiol, Changsha, Hunan, Peoples R China
3.Shanghai Jiao Tong Univ, Renji Hosp, Dept Cardiol, Shanghai 200030, Peoples R China
4.Haerbin Med Univ, Affiliated Hosp 1, Dept Cardiol, Haerbin, Peoples R China
5.Beijing Union Med Coll Hosp, Dept Resp Med, Beijing, Peoples R China
6.Beijing Shijitan Hosp, Dept Pulm Vasc Dis, Beijing, Peoples R China
7.Univ Bologna, Cardiovasc Dept, Bologna, Italy
8.Gen Hosp Shenyang Mil Command, Dept Congenital Heart Dis, Shenyang, Peoples R China
9.Beijing Univ, Hosp 1, Dept Rheumatol & Pediat Cardiol, Beijing 100871, Peoples R China
10.Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Cardiol, Xian 710049, Peoples R China

Recommended Citation:
Jing, Zhi-Cheng,Yu, Zai-Xin,Shen, Jie-Yan,et al. Vardenafil in Pulmonary Arterial Hypertension A Randomized, Double-blind, Placebo-controlled Study[J]. AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE,2011,183(12):1723-1729.
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