Vardenafil Improves Erectile Function in Men with Erectile Dysfunction Irrespective of Disease Severity and Disease Classification

Abstract

Background Vardenafil (Levitra®) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. Methods Data from two pivotal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). Results Data from 1,385 men who received at least one dose of study medication and had pre- and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37–41% of patients had severe ED, 30–34% moderate, 22% mild-to-moderate and 6–8% mild ED. At baseline, 46–51% of patients were considered to have an organic cause for ED, 13–16% psychogenic ED, and 36–38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. Conclusion Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity.

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).…”

Vardenafil Improves Sexual Function and Treatment Satisfaction in Couples Affected by Erectile Dysfunction (ED): A Randomized, Double-Blind, Placebo-Controlled Trial in PDE5 Inhibitor-Naïve Men with ED and Their Partners

“…The observed improvement in erectile function was reflected in the significant increase in men who returned to normal erectile function (IIEF‐EF score ≥26), compared with men who received placebo. The improvement in erectile function was consistent with that seen in previous trials, in which vardenafil demonstrated efficacy in a broad population of men with ED of varying etiology and severity, including men who had undergone prostatectomy and those with diabetes, who are generally considered to be difficult to treat [17–21].…”

Efficacy and Tolerability of Vardenafil in Men With Mild Depression and Erectile Dysfunction: The Depression-Related Improvement With Vardenafil for Erectile Response Study

“…Vardenafil is a potent selective PDE-5 inhibitor that has been shown to be highly efficacious in men with erectile dysfunction, irrespective of severity or disease classification (organic, psychogenic, or mixed) (11) or underlying etiology (12). The drug is well tolerated and is associated with a rapid and reliable treatment response.…”