Sustained efficacy and safety of vardenafil for treatment of erectile dysfunction: A randomized, double-blind, placebo-controlled study

Luc Valiquette, Jay M. Young, Ignacio Moncada, Hartmut Porst, Jean Guy Vézina, Britt Nicole Stancil, Katharine Edmunds, Francesco Montorsi

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVE: To evaluate the reliability, efficacy, and safety of vardenafil, 10 rag, for patients with erectile dysfunction. PATIENTS AND 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 (SEF3) were 87% and 74%, respectively. Of 600 patients challenged with a single dose of vardenafil at 10 mg, 360 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 (P

Original languageEnglish
Pages (from-to)1291-1297
Number of pages7
JournalMayo Clinic Proceedings
Volume80
Issue number10
Publication statusPublished - 2005

ASJC Scopus subject areas

  • Medicine(all)

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