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学科主题: 临床医学
题名:
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
作者: 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
发表日期: 2015
DOI: 10.4103/1008-682X.143244
卷: 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
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
项目资助者: Eli Lilly and Company
WOS记录号: WOS:000352069100013
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/62816
Appears in Collections:北京大学第二临床医学院_泌尿外科_期刊论文

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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

Recommended Citation:
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.
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