Sustained efficacy and safety of vardenafil for treatment of erectile dysfunction: a randomized, double-blind, placebo-controlled study.
OBJECTIVE
To evaluate the reliability, efficacy, and safety of vardenafil, 10 mg, for patients with erectile dysfunction.


METHODS
Vardenafil-naive patients completed a 4-week treatment-free run-in phase and a 1-week single-dose vardenafil (10 mg) open-label challenge phase. Responders to vardenafil in the challenge phase were randomized to 12 weeks of double-blind, fixed-dose treatment with vardenafil at 10 mg or placebo. Diary responses to Sexual Encounter Profile (SEP) questions about erections and attempts at sexual activity were collected after 4, 8, and 12 weeks of randomized treatment. Adverse events were monitored throughout the study.


RESULTS
During the open-label challenge phase, the proportions of patients with a first-time success for penetration (SEP2) and maintenance of erection (SEP3) were 87% and 74%, respectively. Of 600 patients challenged with a single dose of vardenafil at 10 mg, 260 were randomized to vardenafil and 263 to placebo. During the double-blind phase, the reliability of penetration and maintenance rates for patients successful during the challenge phase were significantly greater with vardenafil compared with placebo (83.4% vs 55.8% [SEP2] and 76.6% vs 42.1% [SEP3], respectively). At week 12, patients in the vardenafil group had a consistently higher least squares mean (SE) on the erectile function domain score of the International Index of Erectile Function than patients in the placebo group (23.5 [0.4] vs 15.8 [0.4], respectively [last observation carried forward]) and a greater proportion of positive responses to the Global Assessment Question (80.8% vs 32.3%, respectively [last observation carried forward]) at each assessment (Pc.001). Vardenafil was generally well tolerated; most adverse events were mild to moderate, with headache and flushing reported most frequently.


CONCLUSIONS
During this 12-week study, vardenafil produced consistently higher reliability of penetration and maintenance of erection rates compared to placebo and was generally well tolerated in patients with erectile dysfunction.
Valiquette
Luc
L
Service d'Urologie, Hôpital St-Luc du CHUM, 1058 rue Saint-Denis, Montreal, Quebec, Canada. lucval@videotron.ca
Young
Jay M
JM
Moncada
Ignacio
I
Porst
Hartmut
H
Vézina
Jean-Guy
JG
Stancil
Britt-Nicole
BN
Edmunds
Katharine
K
Montorsi
Francesco
F
D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D017060:Patient Satisfaction; 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