Vardenafil (
Levitra) is a potent and highly selective oral
phosphodiesterase type 5 (
PDE5) inhibitor.
Vardenafil improved erectile function in men with mild to severe
erectile dysfunction (ED) of varying aetiology in two randomised, double-blind, multicentre, fixed-dose studies of 12 or 26 weeks' duration. Men receiving
vardenafil 10 or 20mg had significantly greater improvements in International Index of Erectile Function (IIEF) questionnaire erectile function domain scores than placebo recipients. Moreover, improvements in penetration and maintenance of erection (assessed using IIEF or Sexual Encounter Profile [SEP] questions) were significantly greater with
vardenafil 5-20mg than with placebo. Improvements in IIEF intercourse satisfaction and orgasmic function domain scores were significantly greater with
vardenafil 10 or 20mg than with placebo and the proportion of patients with a positive response to a Global Assessment Question (GAQ) concerning improvement in erections after 12 or 26 weeks'
therapy was significantly higher with
vardenafil 5-20mg than with placebo.
Vardenafil improved erectile function in men with ED associated with
diabetes mellitus or ED following unilateral or bilateral nerve-sparing radical
retropubic prostatectomy in two randomised, double-blind, multicentre, fixed-dose, 3-month studies. In both studies, improvements from baseline in the erectile function domain score of the IIEF and in positive responses to SEP questions were significantly greater with
vardenafil 10 or 20mg than with placebo. In addition, a significantly higher proportion of
vardenafil 10 or 20mg recipients than placebo recipients had positive GAQ responses.
Vardenafil was generally well tolerated in men with ED; treatment-emergent adverse events were of mild to moderate intensity and transient in nature. The most commonly reported adverse events (typical of those seen with
PDE5 inhibitors) in
vardenafil 5-20mg recipients included
headache,
flushing,
rhinitis,
dyspepsia and
sinusitis. There were no reports of abnormal colour vision in men with ED taking
vardenafil at clinically recommended doses (5-20mg).
CONCLUSION: