Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction  

作　　者：Hui Meng Tan Chong Min Chin Chong Beng Chua Edsal Gatchalian Apichat Kongkanand Clarence Lei Chang Moh Foo Cheong Ng Krisada Ratana-Olarn Dennis Serrano Akmal Taher Ismail Tambi Anupan Tantiwong Michael Wong Yuet Chen Wai-Chun Yip 

机构地区：[1]Subang Jaya Medical Centre, Selengor 47500, Malaysia [2]National University Hospital, Singapore 119074 [3]University Malaya Medical Centre, Kuala Lumpur 59100, Malaysia [4]Manila Doctors Hospital, Ermita, Metro Manila, the Philippines [5]Chulalongkorn University Hospital, Bangkok 10330, Thailand [6]Normah Hospital, 93050 Kuching, Malaysia [7]Changi General Hospital, Singapore 529889 [8]Ramathibodi Hospital, Bangkok 10400, Thailand [9]University of lndonesia, Jakarta 10430, Indonesia [10]Damai Service Hospital, Kuala Lumpur 51200, Malaysia [11]Siriraj Hospital, Mahidol University, 10700 Bangkok, Thailand [12]Mount Elizabeth Medical Centre, Singapore228510 [13]Kwong Wah Hospital, Kowloon, Hong Kong, China

出　　处：《Asian Journal of Andrology》2008年第3期495-502,共8页亚洲男性学杂志（英文版）

摘　　要：Aim： To evaluate the efficacy and tolerability of vardenafil, a phosphodiesterase type-5 （PDE-5） inhibitor, in men of Asian ethnicity with erectile dysfunction （ED）. Methods： In this prospective, double-blind, multinational study, Asian men were randomized to receive vardenafil （10 mg） or placebo （4：1 ratio） for 12 weeks. The primary efficacy variables were the International Index of Erectile Function erectile function domain （IIEF-EF）, and Sexual Encounter Profile （SEP） questions related to penetration and intercourse completion. Significant mean improvements were required in all three measures to show positive benefits of vardenafil treatment. Secondary efficacy variables included the Global Assessment Question （GAQ） on erection improvement. Results： Least-squares mean baseline IIEF-EF domain scores （vardenafil 14.6, placebo 13.4） were consistent with moderate ED. After 12 weeks, vardenafil treatment was associated with significant increases from the baseline in IIEF-EF domain scores compared with the placebo （22.4 vs. 14.3; P 〈 0.001）. Vardenafil was associated with significant improvements from baseline in least squares （LS） mean success rates for SEP-2 （vardenafil 82.2 vs. placebo 43.6; P 〈 0.001） and SEP-3 （vardenafil 66.1 vs. placebo 24.0; P 〈 0.001）. Positive GAQ responses were reported by 81.8% of vardenafil recipients vs. 24.3% of placebo recipients. Adverse events were reported by 25.4% of the vardenafil group, the majority mild and transient. Conclusion： Vardenafil （10 mg） is a highly effective and well-tolerated treatment for moderate ED in Asian men. These results add to the increasing amount of data demonstrating the safety and efficacy of vardenafil for the treatment of ED in a range of patient populations.Aim： To evaluate the efficacy and tolerability of vardenafil, a phosphodiesterase type-5 （PDE-5） inhibitor, in men of Asian ethnicity with erectile dysfunction （ED）. Methods： In this prospective, double-blind, multinational study, Asian men were randomized to receive vardenafil （10 mg） or placebo （4：1 ratio） for 12 weeks. The primary efficacy variables were the International Index of Erectile Function erectile function domain （IIEF-EF）, and Sexual Encounter Profile （SEP） questions related to penetration and intercourse completion. Significant mean improvements were required in all three measures to show positive benefits of vardenafil treatment. Secondary efficacy variables included the Global Assessment Question （GAQ） on erection improvement. Results： Least-squares mean baseline IIEF-EF domain scores （vardenafil 14.6, placebo 13.4） were consistent with moderate ED. After 12 weeks, vardenafil treatment was associated with significant increases from the baseline in IIEF-EF domain scores compared with the placebo （22.4 vs. 14.3; P 〈 0.001）. Vardenafil was associated with significant improvements from baseline in least squares （LS） mean success rates for SEP-2 （vardenafil 82.2 vs. placebo 43.6; P 〈 0.001） and SEP-3 （vardenafil 66.1 vs. placebo 24.0; P 〈 0.001）. Positive GAQ responses were reported by 81.8% of vardenafil recipients vs. 24.3% of placebo recipients. Adverse events were reported by 25.4% of the vardenafil group, the majority mild and transient. Conclusion： Vardenafil （10 mg） is a highly effective and well-tolerated treatment for moderate ED in Asian men. These results add to the increasing amount of data demonstrating the safety and efficacy of vardenafil for the treatment of ED in a range of patient populations.

关 键 词：Asian males erectile dysfunction IMPOTENCE phosphodiesterase inhibitors sexual dysfunction VARDENAFIL 

分 类 号：R698.1[医药卫生—泌尿科学]