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Title: Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction
Authors: 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
Subang Jaya Medical Centre
National University Hospital, Singapore
University of Malaya Medical Centre
Manila Doctors Hospital
Chulalongkorn University
Normah Hospital
Changi General Hospital
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Universitas Indonesia
Damai Service Hospital
Mahidol University
Mount Elizabeth Medical Centre
Kwong Wah Hospital
University of Malaya
Keywords: Medicine
Issue Date: 1-May-2008
Citation: Asian Journal of Andrology. Vol.10, No.3 (2008), 495-502
Abstract: 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. © 2008 Asian Journal of Andrology, Shanghai Institute of Materia Medica, Chinese Academy of Sciences.
ISSN: 17457262
Appears in Collections:Scopus 2006-2010

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