Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction:a randomized double-blind,parallel,placebo-controlled clinical study

作     者：Wai Chun Andrew Yip Han-Sun Chiang Jesus Benjamin Mendoza Hui-Meng Tan Man-Kay Li Wei Christine Wang Vladimir Kopernicky 

作者机构：Department of SurgeryKwong Wah HospitalHong KongChina College of MedicineFu Jen Catholic UniversityTaipei 24205TaiwanChina Department of UrologyNational Kidney and Transplant InstituteQuezon City 1100the Philippines Department of UrologySubang Jaya Medical CentreSelangor Darul Ehsan 47500Malaysia Department of UrologyNational University Hospital119074Singapore Lilly Research LaboratoriesEli Lilly and CompanyIndianapolisIndiana 46285USA Lilly Area Medical CenterVienna 1030Austria 

出 版 物：《Asian Journal of Andrology》 (亚洲男性学杂志（英文版）)

年 卷 期：2006年第8卷第6期

页      面：685-692页

核心收录：

学科分类：1002[医学-临床医学] 100210[医学-外科学(含：普外、骨外、泌尿外、胸心外、神外、整形、烧伤、野战外)] 10[医学] 

主　　题：tadalafil phosphodiesterase type 5 inhibitor erectile dysfunction efficacy safety Asian 

摘      要：Aim： To assess the efficacy and safety of tadalafil in comparison to a placebo, when taken on demand for 12 weeks by East/Southeast Asian men with erectile dysfunction （ED）, Methods： This multicenter, randomized, double-blind, parallel group, placebo-controlled study was conducted at 17 centers across East and Southeast Asia between August 2002 and February 2003. Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive a placebo or 20 mg of tadalafil taken as needed （maximum once daily）. Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile diary and Global Assessment Questions. Results： Tadalafil significantly improved erectile function as compared to the placebo （P 〈 0.001）. At the endpoint, the patients receiving 20 mg of tadalafil reported a greater mean per patient percentage of successful intercourse attempts （Sexual Encounter Profile question 3： 70.9% compared to 33.5% in the placebo） and a greater proportion of improved erections （Global Assessment Question： 86.2% compared to 30.1%）. Most （≥3%） treatment emergent adverse events were mild or moderate. The most common treatment emergent adverse events were headache, back pain, dizziness and dyspepsia. Conclusion： Tadalafil was an effective and well-tolerated treatment for ED in East and Southeast Asian men.