IngentaConnect Efficacy of Vardenafil and Influence on Self-Esteem and Self-Conf...

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. Conclusions.

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. Martin-Morales A, Meijide F, García N, Artes M, and Muñoz A. Efficacy of vardenafil and influence on self-esteem and self-confidence in patients with severe erectile dysfunction. J Sex Med 2007;4:440-447.

Keywords: Erectile Dysfunction; Vardenafil; Quality of Life; Efficacy; Safety; Self-esteem; Self-confidence

Document Type: Research article

DOI: 10.1111/j.1743-6109.2006.00426.x

Affiliations: 1: Clínica Povisa, Vigo, Spain; 2: Química Farmacéutica Bayer, Barcelona, Spain; 3: Adelphi Targis, Barcelona, Spain

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