TY - JOUR
T1 - Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction
AU - Tan, Hui Meng
AU - Chin, Chong Min
AU - Chua, Chong Beng
AU - Gatchalian, Edsal
AU - Kongkanand, Apichat
AU - Moh, Clarence Lei Chang
AU - Ng, Foo Cheong
AU - Ratana-olarn, Krisada
AU - Serrano, Dennis
AU - Taher, Akmal
AU - Tambi, Ismail
AU - Tantiwong, Anupan
AU - Chen, Michael Wong Yuet
AU - Yip, Wai Chun
PY - 2008/5
Y1 - 2008/5
N2 - 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.
AB - 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.
KW - Asian males
KW - Erectile dysfunction
KW - Impotence
KW - Phosphodiesterase inhibitors
KW - Sexual dysfunction
KW - Vardenafil
UR - http://www.scopus.com/inward/record.url?scp=42549085782&partnerID=8YFLogxK
U2 - 10.1111/j.1745-7262.2008.00388.x
DO - 10.1111/j.1745-7262.2008.00388.x
M3 - Article
C2 - 18385912
AN - SCOPUS:42549085782
SN - 1008-682X
VL - 10
SP - 495
EP - 502
JO - Asian Journal of Andrology
JF - Asian Journal of Andrology
IS - 3
ER -