Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction.
OBJECTIVE
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.


CONCLUSIONS
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.
Tan
Hui Meng
HM
Faculty of Medicine, University of Malaya, 1, SS12/1A, Subang Jaya Medical Centre, 47500 Petaling Jaya, Selangor Malaysia. perandro@streamyx.com
Chin
Chong Min
CM
Chua
Chong Beng
CB
Gatchalian
Edsal
E
Kongkanand
Apichat
A
Moh
Clarence Lei Chang
CL
Ng
Foo Cheong
FC
Ratana-Olarn
Krisada
K
Serrano
Dennis
D
Taher
Akmal
A
Tambi
Ismail
I
Tantiwong
Anupan
A
Chen
Michael Wong Yuet
MW
Yip
Wai-Chun
WC
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride