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A randomized clinical trial investigating treatment choice in Chinese men receiving sildenafil citrate and tadalafil for treating erectile dysfunction

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Asian Journal of Andrology 2017年第4期19卷 500-504页

作者： Wen-Jun Bai Hong-Jun Li Jian-Jun Jin Wen-Ping Xu sorsaburu sebastian Xiao-Feng Wang Department of Urology Peking University People's Hospital Beijing 100044 China Department of Urology Peking Union Medical College Hospital Beijing 100730 China Department of Medical Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai 200021 China Eli Lilly and Company Indianapolis Indiana 46285 USA

Sildenafil and tadalafil are efficacious and well tolerated in Chinese men with erectile dysfunction （ED）. Recent study results indicate that men with ED in China who were naive to phosphodiesterase inhibitor type 5 （PDE5） therapy prefer tadalafil 20-mg （on-demand） versus sildenafil 100-mg （on-demand）. Differences in psychosocial outcomes may help to explain treatment preference in favor of tadalafih This open-label, randomized, crossover study compared psychosocial outcomes and drug attribute choices between tadalafil and sildenafil in Chinese men with ED na＇（ve to PDE5 inhibitor therapy. Eligible patients were randomized to sequential 20-mg tadalafU/lOO-mg sildenafil （n = 190） or 100-mg sildenafil/20-mg tadalafil （n = 193） for 8 weeks each and were asked which treatment they preferred to take for the 8-week extension phase. Psychosocial outcomes were assessed using the Psychological and Interpersonal Relationship Scale （PAIRS）, Drug Attributes Questionnaire （DRAQ）, and Sexual Life Quality Questionnaire （SLQQ）. When taking tadalafil versus sildenafil, men had a higher mean endpoint score on the PAIRS Spontaneity Domain （tadalafil = 2.86 vs sildenafil = 2.72; P 〈 0.001）, and a lower mean endpoint score on the Time Concerns Domain （tadalafil = 2.41 vs sildenafil = 2.55; P 〈 0.001）. A numerical increase in the Sexual Self-Confidence Domain was observed when taking tadalafil versus sildenafil （tadalafil -- 2.76 vs sildenafil = 2.72; P= 0.102）. The most frequently chosen drug attributes explaining treatment preference were able to get an erection long after having drug, and ability to get an erection every time. SLQQ results were comparable between treatment groups. These psychosocial outcomes may explain why more Chinese men preferred tadalafil versus sildenafil for the treatment of ED in this clinical trial.

关键词： drug attributes erectile dysfunction phosphodiesterase type 5 inhibitor psychological assessment of sexual dysfunction

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An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalahl for treating erectile dysfunction in Chinese men na＇=＇ve to phosphodiesterase 5 .inhibitor therapy

引用

Asian Journal of Andrology 2015年第1期17卷 61-67,I0007,I0008页

作者： Wen-Jun Bai Hong-Jun Li Yu-Tian Dai Xue-You He Yi-Ran Huang Ji-Hong Liu sebastian sorsaburu Chen Ji Jian-Jun Jin Xiao-Feng Wang Department of Urology People's Hospital of Peking University Beijing China Department of Urology Peking Union Medical College Hospital Beijing China Department of Andrology Nanjing Drum Tower Hospital Jiangsu China Department of Urology Chinese PLA General Hospital Beijing China Department of Urology Shanghai Renji Hospital Shanghai China Department of Urology Tongji Hospital Tengji Medical College of Huazhong University of Science and Technology Wuhan China Department of Medical Eli Lilly and Company Indianapolis IN USA Department of Medical Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai China.

The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate （sildenafil） and tadalafil for treating erectile dysfunction （ED） in Chinese men na＇ive 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 lO0-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 na＇ive to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe.

关键词： erectile dysfunction patient preference phosphodiesterase 5 inhibitors

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