Earliest Time to Onset of Action Leading to Successful Intercourse with Vardenafil Determined in an At-Home Setting: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Introduction Vardenafil, a potent and selective oral PDE5 inhibitor, is efficacious and generally well-tolerated in men with erectile dysfunction (ED). Of considerable interest to patients and physicians is an understanding of the time required after dosing to attain penile erection sufficient for successful sexual intercourse. Aim To determine the earliest time to onset of action of vardenafil 10 and 20 mg leading to successful intercourse compared to placebo in men with ED. Methods A prospective, randomized, double-blind, parallel-group, at-home study of 732 men with ED (mean age 55.5 years) was conducted at 64 sites in North America and Europe. Following a 4-week run-in period, patients were randomized to either vardenafil 10 (N = 237) or 20 mg (N = 248) or placebo (N = 247) to be taken on demand over 4 weeks. Using a stopwatch, patients recorded the elapsed time from dosing to attainment of an erection perceived to be adequate for penetration that led to intercourse completion. Earliest time of onset was defined as the fastest time among the first four doses for each patient. Time points from 25 to 5 minutes were tested for significance (alpha = 0.025) using a backward stepping procedure. Results Mean baseline erectile function domain score (13.4) indicated moderate ED. Within 25 minutes after dosing, 50%/53% of men on vardenafil 10/20 mg had at least one erection in the first four doses perceived to be sufficient for penetration with subsequent intercourse completion compared to 26% on placebo (P < 0.0001). A statistically superior response to vardenafil vs. placebo was observed in these responders at all times ≥ 10 and ≥ 11 minutes (P < 0.025) in the 10 and 20 mg groups, respectively. In a retrospective analysis using time intervals of ≤ 15, ≤ 20, ≤ 25 and ≤ 30 minutes between dosing and erection adequate for penetration, 75–77% of these intercourse attempts were successful (SEP3 positive) by patients receiving vardenafil 10/20 mg, compared to 45–47% of attempts by those who received placebo. Vardenafil 10/20 mg was generally well-tolerated with headache (7%/12% vs. 1%) and flushing (6%/9% vs. < 1%) reported more frequently than with placebo. No patient discontinued vardenafil therapy due to adverse events. Conclusion In this large, at-home study, the onset of action of vardenafil with subsequent intercourse completion was recognized as early as 10 minutes after dosing.

Efficacy of Vardenafil and Influence on Self-Esteem and Self-Confidence in Patients with Severe Erectile Dysfunction

“…The present study showed that vardenafil effectively improves EF compared with placebo, consistent with the findings of other clinical studies with vardenafil [11][12][13][14][15][16][17][18][19]. For the primary efficacy variable (change in IIEF-EF domain score at week 12), the analysis showed a highly statistically significant difference in favor of vardenafil (P < 0.001).…”

Phosphodiesterase Type 5 Inhibitors: Unmet Needs

“…The onset of action of PDE5i has been defined in clinical trials and all 3 drugs may offer good response in some patients in about 15min; sildenafil may be successful in 35% of men after 14 min, tadalafil in 32% after 16 min, while vardenafil in 23% after 11min [63][64][65]. In the everyday clinical practice however, such data may lead to misuse of the drugs and an increased number of non-responders.…”

ACceptance of Therapy In Vardenafil-treated patients with Erectile dysfunction (ACTIVE): a noninterventional study in Germany

“…Such success rates are important for patient confidence and compliance with treatment, 23 and 19 whereas in the ReliabilityVardenafil for Erectile Dysfunction I (RELY-I) study, first-dose penetration success rates ranged from 75 to 84% for patients with diabetes, dyslipidemia and hypertension. 23 Further placebo-controlled studies have shown the rapid onset of action of vardenafil, with more than 50% of participants achieving erections within 25 min, 24 and as rapidly as 15 min. 25 The incidence of AEs in this study was low and comparable with previous studies.…”