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An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naive to phosphodiesterase 5 inhibitor therapy
Bai, Wen-Jun1; Li, Hong-Jun2; Dai, Yu-Tian3; He, Xue-You4; Huang, Yi-Ran5; Liu, Ji-Hong6; Sorsaburu, Sebastian7; Ji, Chen8; Jin, Jian-Jun8; Wang, Xiao-Feng1
关键词erectile dysfunction patient preference phosphodiesterase 5 inhibitors
刊名ASIAN JOURNAL OF ANDROLOGY
2015
DOI10.4103/1008-682X.143244
17期:1页:61-67
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Andrology ; Urology & Nephrology
资助者Eli Lilly and Company ; Eli Lilly and Company
研究领域[WOS]Endocrinology & Metabolism ; Urology & Nephrology
关键词[WOS]PATIENT-PREFERENCE ; EXTENDED DURATION ; DOUBLE-BLIND ; VARDENAFIL ; EFFICACY ; INTERCOURSE ; PARTNERS ; TRIAL
英文摘要

The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in Chinese men nave to phosphodiesterase 5 (PDE5) inhibitor therapies. This multicenter, randomized, open-label, crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil. After a 4 weeks baseline assessment, 383 eligible patients were randomized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension. Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Questionnaire (PITPQ). Secondary efficacy was analyzed by PITPQ Question 2, the International Index of Erectile Function (IIEF) erectile function (EF) domain, sexual encounter profile (SEP) Questions 2 and 3, and the Drug Attributes Questionnaire. Three hundred and fifty men (91%) completed the randomized treatment phase. Two hundred and forty-two per 350 (69.1%) patients preferred 20-mg tadalafil, and 108/350 (30.9%) preferred 100-mg sildenafil (P < 0.001) as their treatment in the 8 weeks extension. Ninety-two per 242 (38%) patients strongly preferred tadalafil and 37/108 (34.3%) strongly the preferred sildenafil. The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups. For patients who preferred tadalafil, getting an erection long after taking the medication was the most reported reason for tadalafil preference. The only treatment-emergent adverse event reported by > 2% of men was headache. After tadalafil and sildenafil treatments, more Chinese men with ED nave to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe.

语种英语
资助者Eli Lilly and Company ; Eli Lilly and Company
WOS记录号WOS:000352069100013
引用统计
被引频次:6[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/62816
专题北京大学第二临床医学院_泌尿外科
作者单位1.Peking Univ, Peoples Hosp, Dept Urol, Beijing 100871, Peoples R China
2.Beijing Union Med Coll Hosp, Dept Urol, Beijing, Peoples R China
3.Nanjing Drum Tower Hosp, Dept Androl, Nanjing, Jiangsu, Peoples R China
4.Chinese Peoples Liberat Army Gen Hosp, Dept Urol, Beijing 100853, Peoples R China
5.Shanghai Renji Hosp, Dept Urol, Shanghai, Peoples R China
6.Eli Lilly & Co, Dept Med, Indianapolis, IN 46285 USA
7.Lilly Suzhou Pharmaceut Co Ltd, Dept Med, Shanghai, Peoples R China
8.Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Urol, Wuhan 430074, Peoples R China
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GB/T 7714
Bai, Wen-Jun,Li, Hong-Jun,Dai, Yu-Tian,et al. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naive to phosphodiesterase 5 inhibitor therapy[J]. ASIAN JOURNAL OF ANDROLOGY,2015,17(1):61-67.
APA Bai, Wen-Jun.,Li, Hong-Jun.,Dai, Yu-Tian.,He, Xue-You.,Huang, Yi-Ran.,...&Wang, Xiao-Feng.(2015).An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naive to phosphodiesterase 5 inhibitor therapy.ASIAN JOURNAL OF ANDROLOGY,17(1),61-67.
MLA Bai, Wen-Jun,et al."An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naive to phosphodiesterase 5 inhibitor therapy".ASIAN JOURNAL OF ANDROLOGY 17.1(2015):61-67.
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