Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction.

Author(s): Stief C, Porst H, Saenz De Tejada I, Ulbrich E, Beneke M, Vardenafil Study Group

Affiliation(s): Department of Urology, Medizinische Hochschule, Hannover, Germany. stief.christian@mh-hannover.de

Publication date & source: 2004-03, Int J Clin Pract., 58(3):230-9.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

This randomised, double-blind study assessed the long-term efficacy and tolerability of vardenafil 10 and 20 mg in men with erectile dysfunction (ED). A total of 566 men who completed an initial 12-month treatment period entered a 12-month extension. In these men, both doses of vardenafil produced improvement in scores for the 'erectile function' Domain of the International Index of Erectile Function, evident from week 4 and maintained through 2 years. Sexual Encounter Profile diary responses indicated that following treatment, penetration was achieved on 92-94% of attempts and erections that lasted long enough for successful intercourse were achieved on 87-89% of attempts. In response to the General Assessment Question, 90-92% of patients reported improved erections with vardenafil. Most treatment-emergent events were mild and transient with no cardiovascular safety concerns. These results support the long-term efficacy, reliability and tolerability of vardenafil 10 and 20 mg in men with ED.