Time to Onset of Action of Vardenafil: A Retrospective Analysis of the Pivotal Trials for the Orodispersible and Film-Coated Tablet Formulations

Authors


Frans M.J. Debruyne, MD, PhD, Department of Urology, Andros Men's Health Institutes, P.O. Box 30005, 6803 AA Arnhem, the Netherlands. Tel: (3126) 389-1753; Fax: (3126) 389-1754; E-mail: f.debruyne@urologicconsultancy.com

ABSTRACT

Introduction.  Patients and physicians consider a rapid onset of action to be an important attribute of oral pharmacotherapy for erectile dysfunction.

Aim.  To investigate the time to onset of action of a new orodispersible tablet (ODT) formulation of vardenafil.

Methods.  A post hoc integrated analysis was performed on data from two 12-week, double-blind, multicenter, randomized, parallel-group, placebo-controlled phase III trials of 10 mg vardenafil ODT. Data for the vardenafil film-coated tablet were generated from a retrospective integrated analysis at week 12 of four double-blind, multicenter, randomized, parallel-group, fixed-dose, placebo-controlled phase III trials. Time intervals (in 15-, 30-, and 60-minute increments, up to ≥6 hours after study medication intake) were determined for the period between dosing and start of sexual activity (with the intention of intercourse).

Main Outcome Measures.  The total number of sexual intercourse attempts and Sexual Encounter Profile question 3 (SEP3) success rates were calculated per time interval.

Results.  Within 15 minutes postdosing, mean per-patient SEP3 success rates were 62.5% (vardenafil ODT) vs. 29.4% (placebo), with corresponding overall SEP3 success rates of 59.8% and 38.2%. In this time interval, 5.3% vs. 2.8% of all sexual activity attempts were initiated by subjects taking vardenafil ODT (n = 89) or placebo (n = 62), respectively.

At 16–30 minutes postdosing, SEP3 success rates were 65.3% and 32.6% (mean per-patient) and 70.2% and 51.0% (overall) for vardenafil ODT vs. placebo, respectively, with a corresponding 10.4% and 8.7% of all sexual activity attempts being made by subjects taking vardenafil ODT (n = 170) or placebo (n = 118).

Comparable results were observed for vardenafil 10 and 20 mg film-coated tablet at corresponding time intervals.

Conclusions.  Vardenafil ODT shows a rapid onset of action comparable with that of vardenafil film-coated tablet. In those men who begin sexual activity within 30 minutes after dosing, the majority of sexual attempts lead to successful intercourse. Debruyne FMJ, Gittelman M, Sperling H, Börner M, and Beneke M. Time to onset of action of vardenafil: A retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med 2011;8:2912–2923.

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