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

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.

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

“…20 Vardenafil (film-coated tablet and oro-dispersible tablet) also seems to have a quick onset of action within 30 minutes after intake. 21 The t 1/2 values of tadalafil and udenafil are longer compared with the other PDE5 inhibitors, which could be due to slower intestinal absorption and/or slower degradation of this drug by the liver. This reflects in clinical practice a more extended duration of action.…”

Duration of Erection: Does It Really Matter? A Randomized, Double-Blind Clinical Trial to Assess the Impact of Vardenafil ODT on Duration of Erection and Its Correlation with Patients' and Partners' Sexual Quality of Life and Duration of Intercourse: The VADEOPEN Study

“…Primary efficacy end points in men were (i) duration of erection (minutes) at any attempt, timed by the man with a stopwatch that was started when erection was perceived hard enough to penetrate and stopped at the time of withdrawal from the partner's vagina, either with or without ejaculation; (ii) duration of erection (minutes) leading to successful intercourse as assessed by the SEP-3 question, "Did your erection last long enough for you to have successful intercourse? "; and (iii) erectile function measured by the EF-IIEF, where a score 26-30 indicates normal erectile function, and severity is classified as "severe" (0-6), "moderate" (7)(8)(9)(10)(11)(12), "mild to moderate" (13)(14)(15)(16)(17)(18), and "mild" (19)(20)(21)(22)(23)(24) [2]. Secondary end points were (i) per-patient SEP-3 response rate, calculated by dividing the number of positive responses by the total number of recorded sexual events, and (ii) sexual QoL assessed by the modified 10 items, 4 weeks recall, Spanish validated version of the sexual QoL domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QoL) [18,19].…”

Safety, Efficacy, and Patient and Partner Acceptability of Vardenafil Orally Disintegrating Tablets for the Treatment of Erectile Dysfunction

“…8 Additionally, there has been a retrospective analysis of these two trials and several studies on film-coated vardenafil specifically looking at time-to-onset of efficacy. 9 …”

“…9 This analysis was conducted to determine if time to onset of medication activity was different between the film-coated and ODT forms of vardenafil. Patients were asked to complete a diary within 24 hours of each sexual attempt to assess when medication was taken, time of initiation of sexual activity and success at particular time points.…”