Vardenafil is effective and well-tolerated for treating erectile dysfunction in a broad population of men, irrespective of age

OBJECTIVES To assess the efficacy and safety of vardenafil in the treatment of erectile dysfunction (ED) in men of different age groups. PATIENTS AND METHODS In a retrospective pooled subgroup analysis of randomized, double-blind, placebo-controlled studies, men from the general population with ED received either placebo or vardenafil 5, 10 or 20 mg over 12 weeks. Efficacy variables included the erectile function (EF) domain score from The International Index of Erectile Function, diary response rates to questions on vaginal penetration and maintenance of erection, and positive responses to the Global Assessment Question (GAQ) ‘Has the treatment you have been taking over the past 4 weeks improved your erections?’. The 1385 men were grouped by age (<45, 45–64 and ≥65 years). RESULTS At 12 weeks the EF domain scores approached 20 with vardenafil and 14 with placebo in men aged ≥ 65 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). The corresponding scores were 22 and 14 in men aged 45–64 years and up to 24 and 16 in those aged <45 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). Vardenafil generated positive GAQ responses in ≈ 71%, 76% and 85% of men aged <45, 45–64 and ≥ 65 years (P ≤ 0.001 vardenafil vs placebo). The corresponding placebo rates were 23%, 25% and 34%. The most common treatment-emergent adverse events were headache, rhinitis, flushing and dyspepsia, which were mild to moderate, transient and unrelated to age. CONCLUSION Vardenafil is an effective and generally well-tolerated treatment for ED, irrespective of age.