Efficacy of vardenafil and influence on self-esteem and self-confidence in patients with severe erectile dysfunction.
OBJECTIVE
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.


METHODS
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
Antonio
A
Department of Urology, Hospital Carlos Haya, Malaga, Spain. AMARTINMORALES@terra.es
Meijide
Fernando
F
García
Nicolás
N
Artes
Maite
M
Muñoz
Ana
A
D000328:Adult; D000368:Aged; D003075:Coitus; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D010879:Piperazines / Q000008:administration & dosage*; D011788:Quality of Life; D012649:Self Concept; D012720:Severity of Illness Index; D013030:Spain; D013450:Sulfones / Q000008:administration & dosage; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride