Volume 10, Issue 3 (May 2008) 10, 495–502; 10.1111/j.1745-7262.2008.00388.x
Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction
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 and Wai-Chun Yip
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 Indonesia, Jakarta 10430, Indonesia
10.Damai Service Hospital, Kuala Lumpur 51200, Malaysia
11.Siriraj Hospital, Mahidol University, 10700 Bangkok, Thailand
12.Mount Elizabeth Medical Centre, Singapore 228510
13.Kwong Wah Hospital, Kowloon, Hong Kong, China
Correspondence: Dr Hui Meng Tan, Faculty of Medicine, University of Malaya, 1, SS12/1A, Subang Jaya, 47500 Petaling Jaya, Selangor Malaysia. Fax: +60-3563-06571. E-mail: email@example.com
Received 26 October 2007; Accepted 12 January 2008.
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.
Keywords: Asian males, erectile dysfunction, impotence, phosphodiesterase inhibitors, sexual dysfunction, vardenafil
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