Efficacy and Safety of an Orodispersible Vardenafil Formulation for the Treatment of Erectile Dysfunction in Elderly Men and Those with Underlying Conditions: An Integrated Analysis of Two Pivotal Trials

Abstract

Introduction Men with erectile dysfunction (ED) are typically older and have one or more underlying cardiovascular conditions. Aim To determine the efficacy and safety of a new orodispersible tablet (ODT) formulation of vardenafil for the treatment of ED, and whether age, or the presence of underlying conditions affects treatment outcomes. Methods This is an integrated analysis of data from two phase III, double-blind, multicenter, randomized, parallel-group, placebo-controlled studies that compared 10 mg on-demand vardenafil ODT with placebo in a general population of men with ED, stratified so that approximately 50% of patients were aged ≥65 years. Results were reported by age (<65 vs. ≥65 years) and presence/absence of diabetes, dyslipidemia, or hypertension. Main Outcome Measures Primary measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3). Results Of the 701 men randomized (51% aged ≥65 years), 686 were included in the intent-to-treat population (placebo, n = 334; vardenafil ODT, n = 352). Vardenafil ODT was significantly superior to placebo for all primary efficacy measures, regardless of age, baseline ED severity, or underlying condition (P < 0.0001 for vardenafil vs. placebo for each endpoint). IIEF-EF scores and SEP2/3 success rates in older patients and men with underlying conditions were not significantly different to those of younger patients or men without underlying conditions. Adverse events (AEs) were mostly mild to moderate in severity, occurring with higher incidence in the vardenafil vs. placebo group. The most frequently reported drug-related AEs in the vardenafil group were headache, flushing, nasal congestion, dizziness, and dyspepsia, consistent with the known safety profile of phosphodiesterase type 5 inhibitors. Conclusions Vardenafil ODT significantly improves erectile function in men with ED regardless of age, baseline ED severity, or underlying condition.

Bioequivalence study of a new sildenafil 100 mg orodispersible film compared to the conventional film-coated 100 mg tablet administered to healthy male volunteers

“…Orally disintegrating film and tablet formulations of PDE5 inhibitors that disintegrate in the patient’s mouth without the need for swallowing with water have been developed 7–12. Orodispersible films are defined as single or multilayer sheets of suitable materials, to be placed in the mouth where they disperse rapidly,13 requiring only a small amount of saliva on the tongue to dissolve within a few minutes of administration.…”

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

“…The study population has been described previously [6]. Across the two studies, a total of 701 subjects were randomized to treatment (vardenafil ODT, n = 358; placebo, n = 343).…”

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

“…8 For patients less than 65 years of age, cardiac disorders were noted in 15.2% and 6.9% of placebo and vardenafil ODT patients respectively. The younger patient group had documented diabetes in 24% of both placebo and treatment groups, dyslipidemia in at least 28% and hypertension in at least 30%.…”

“…An integrated analysis has been performed combining the data from POTENT I and POTENT II. 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 …”