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

Abstract

Aim To assess the efficacy of vardenafil in a population of Spanish men with erectile dysfunction (ED), its influence on patients’ self-esteem and self-confidence, and its effect on their quality of life. Main Outcome Measures Efficacy was assessed by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain, the Rosenberg Self-Esteem scale, the Johnson and McCoy Self-Confidence scale, the Medical Outcome Short Form (SF-36) scale, items 2 and 3 of the Sexual Encounter Profile questionnaire, and the Global Assessment Question (GAQ). Safety assessments included laboratory tests, physical exam, electrocardiogram, vital signs, and adverse events. Methods This was a randomized, double-blind, multicenter, placebo-controlled study. After a 4-week treatment-free period, patients received flexible-dose vardenafil or placebo for 12 weeks. The initial dose was 10 mg, which could be titrated up to 20 mg or down to 5 mg at weeks 4 and 8. Results A total of 121 patients were included in the intention-to-treat analysis (61 on vardenafil and 60 on placebo). Of these, 16 in the vardenafil group and 14 in the placebo group had severe ED. There was a greater improvement in IIEF-EF domain score with vardenafil vs. placebo for all patients (score change of 10.9 vs. 1.6, respectively, P < 0.001) and for patients with severe ED (score change of 13.4 vs. 2.2, respectively, P = 0.011). A significant difference in favor of vardenafil was also observed for positive responses to the GAQ (73.8% vs. 25.0%, P < 0.001). After 12 weeks, vardenafil-treated patients with severe ED showed a significant improvement in their self-esteem compared with patients receiving placebo (change from baseline −1.51 vs. 3.54, respectively, P = 0.036). Vardenafil treatment was well tolerated. Conclusion Vardenafil was highly effective for improving EF in all patients with ED, and resulted in significant improvements in self-esteem in patients with severe ED.

Premature ejaculation: therapist perspectives

“…Longitudinal research is required to monitor the manner in which PE influences and is influenced by anxiety and self-esteem and the extent to which treatment may improve these (Martin-Morales, Meijide, Garcia, Artes, & Munoz, 2007). Recognition of these issues is consistent with the suggestion that supporting recovery of self-confidence and reduction of anxiety should form part of modern psychosexual therapy for PE (Montorsi, et al, 2010).…”

Evaluación de la autoestima en varones con disfunción eréctil tratados con sildenafilo: Análisis de un grupo de pacientes españoles procedentes de un estudio multicéntrico internacional

“…Nuestro trabajo está en concordancia con otros estudios que revelan la importancia de la repercusió n de la disfunció n eré ctil sobre el comportamiento psicosocial 32 , y ademá s es una confirmació n del cambio positivo que se produce al tratar la disfunció n eré ctil, lo que tambié n coincide con los resultados obtenidos con otros inhibidores de la fosfodiesterasa 5 y otro tipo de escala 33,34 .…”

Is Vardenafil “Noninferior” or Superior to Sildenafil in the Management of Erectile Dysfunction? Revisiting the Biochemical, Physiological, and Clinical Evidence

“…Several clinical studies have suggested that vardenafil is an effective and efficacious inhibitor of PDE5 enzyme in the management of ED [28–32]. A recent head‐to‐head crossover design clinical trial [2] of vardenafil and sildenafil (N = 931) demonstrated that vardenafil treatment was associated with greater improvements in erectile function (EF), as assessed by validated questionnaires.…”