Vardenafil Improves Satisfaction Rates, Depressive Symptomatology, and Self‐Confidence in a Broad Population of Men with Erectile Dysfunction

• Published in: Journal of sexual medicine 2005-01, Vol.2 (1), p.109-116
• Main Authors: Hatzichristou, Dimitrios, Cuzin, Beatrice, Martin‐Morales, Antonio, Buvat, Jacques, Porst, Hartmut, Laferriere, Nicole, Bandel, Tiemol Jerg, Montorsi, Francesco
• Format: Article
• Language: English
• Subjects: Analysis of Variance; At-Home Trial; Depression; Depression - prevention & control; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Erectile Dysfunction - drug therapy; Humans; Imidazoles - pharmacology; Imidazoles - therapeutic use; Logistic Models; Male; Middle Aged; Patient Satisfaction; PDE5 Inhibitor; Phosphodiesterase Inhibitors - pharmacology; Phosphodiesterase Inhibitors - therapeutic use; Piperazines - pharmacology; Piperazines - therapeutic use; Prospective Studies; Self Concept; Sulfones - pharmacology; Sulfones - therapeutic use; Triazines - pharmacology; Triazines - therapeutic use; Vardenafil; Vardenafil Dihydrochloride
• ISSN: 1743-6095; 1743-6109
• DOI: 10.1111/j.1743-6109.2005.20111.x

Vardenafil is a potent and selective phosphodiesterase 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction (ED). Fixed‐dose and flexible‐dose studies have previously established the efficacy and tolerability of vardenafil. To assess, besides the usual measures of efficacy, the quality of erection, satisfaction with the sexual experience, symptoms of depression, and overall confidence. This 12‐week double‐blind, placebo‐controlled flexible‐dose study assessed patients from the general ED population. Patients underwent a 4‐week treatment‐free period before randomization to vardenafil or matching placebo. Initial dosage was vardenafil 10 mg for 4 weeks. At 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose switching was also optional for the last 4 weeks. This paper describes per‐patient success in satisfaction with hardness of erection, satisfaction with overall sexual experience, effect on overall self‐confidence, and an assessment of symptoms of depression using the Center for Epidemiologic Studies Depression Scale. Mean per‐patient satisfaction rates with erection hardness increased after vardenafil treatment to 43%, 59%, and 63% at weeks 4, 8, and 12, respectively, compared to placebo with 10%, 21%, and 23% (all P