The POTENT I Randomized Trial: Efficacy and Safety of an Orodispersible Vardenafil Formulation for the Treatment of Erectile Dysfunction

Abstract

Introduction Orodispersible tablet (ODT) formulations offer improved convenience over film-coated formulations and are preferred by many patients. Aim To investigate the efficacy and safety of an ODT formulation of 10 mg vardenafil administered on demand vs. placebo in a general population of men with erectile dysfunction (ED). Methods This was a 16-week, double-blind, multicenter, randomized, parallel-group, placebo-controlled study conducted at 40 centers across Europe and South Africa. Eligible participants were men aged ≥18 years with ED for at least 6 months, in a stable heterosexual relationship for at least 6 months, highly motivated to obtain ED treatment, and making at least four attempts at sexual intercourse on four separate days, of which at least half were unsuccessful. Subjects were randomized to receive 12 weeks of treatment with either 10 mg vardenafil ODT on demand or placebo, and each treatment group was stratified such that approximately half of the subjects were aged ≥65 years. Main Outcome Measures Primary measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and the Sexual Encounter Profile questions 2 and 3 (SEP2, SEP3). Secondary measures included SEP diary questions 1, 4, 5, and 6; the Treatment Satisfaction Scale; and the Global Assessment Question. Results Of the 409 men enrolled (54.8% aged ≥65 years), 355 were included in the intent-to-treat population (vardenafil ODT, N=183; placebo, N=172). Vardenafil ODT therapy was statistically significantly superior to placebo for all primary (IIEF-EF, SEP2, SEP3) and secondary efficacy measures (all P <0.0001). The incidence and type of treatment-related adverse events with vardenafil 10 mg ODT were comparable with those of the film-coated tablet formulation. Conclusions Treatment with 10 mg vardenafil ODT, taken on demand, significantly improved erectile function and was well tolerated in a broad population of men with ED.

Erectile Dysfunction in the Elderly: An Old Widespread Issue with Novel Treatment Perspectives

“…Recently an orodispersible tablet (ODT) formulation of vardenafil has been developed, which dissolves in the subject's mouth (supralingual formulation) [82]. Vardenafil ODT is very advantageous because it has a 1.21-to-1.44-fold higher bioavailability than the film-coated tablet formulation (as measured by the area under the plasma concentration versus time curve (AUC)), and maximum concentrations in plasma after a single dose (Cmax) are comparable between the two formulations [82].…”

“…Vardenafil ODT is very advantageous because it has a 1.21-to-1.44-fold higher bioavailability than the film-coated tablet formulation (as measured by the area under the plasma concentration versus time curve (AUC)), and maximum concentrations in plasma after a single dose (Cmax) are comparable between the two formulations [82]. Therefore, the pharmacokinetics of ODT vardenafil is not equivalent to that of the film-coated tablets, because the ODT formulation provides greater vardenafil systemic exposure [83].…”

Vardenafil for the treatment of erectile dysfunction

“…The study proved that the adverse effects were the same with the film-coated tablet formulation [26].…”

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

“…The two trials were named POTENT I and POTENT II based on the title "Pivotal phase III trial to investigate the efficacy and safety of an orodispersible tablet vardenafil versus placebo in the treatment of men with erectile dysfunction: a fixed-dose, double-blind, randomized, multi-center trial". 6,7 Unique to POTENT trials (compared to film coated PDE5i trials) was the effort to evaluate men over the age of 65 years, with approximately 50% of patients above this age.…”

“…6 POTENT II included men recruited at 35 medical facilities from Australia, United States, Mexico and Canada. 7 As phase III studies, both were funded by Bayer Schering Pharma and investigators from the company provided support in the study.…”