Efficacy and safety of flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction.

Introduction: Erectile dysfunction (ED) affects up to 70% of men with diabetes, occurring with a higher prevalence in those with type 1 diabetes than with type 2 diabetes. Studies investigating treatment of ED in men with diabetes have largely been conducted in a total male population with diabetes. Limited data are available on the efficacy and safety of the potent oral phosphodiesterase-5 inhibitor vardenafil in men with ED and type 1 diabetes.

Aims: To evaluate the safety and efficacy of flexible-dose vardenafil therapy in a prospective randomized study in phosphodiesterase 5 inhibitor-naïve subjects with type 1 diabetes and ED.

Methods: In this multicenter, double-blind, placebo-controlled clinical trial, phosphodiesterase-5 inhibitor-naïve patients were randomized to receive placebo (N = 149) or flexible-dose (5-20 mg) (N = 153) vardenafil.

Main Outcome Measure: Sexual Encounter Profile diary questions 2 and 3, concerning success rates of vaginal insertion and maintenance of erection to allow successful intercourse, respectively.

Results: Vardenafil significantly improved mean success rates for Sexual Encounter Profile 2 and 3 compared with baseline and placebo at 4, 8, and 12 weeks (P < 0.0001, intention to treat and last observation carried forward). These rates were unaffected by stratification into distinct subsets according to the level of HbA(1c) (HbA(1c) < 7%, good glycemic control; HbA(1c) >7- < or = 8%, moderate glycemic control; and HbA(1c) > 8%, poor glycemic control). Vardenafil treatment also significantly improved the Erectile Function domain score (P < 0.0001) of the International Index of Erectile Function compared with placebo, in addition to scores for the other individual domains of the International Index of Erectile Function. The most commonly reported treatment-emergent adverse events were headache (3.1%) and flushing (2.5%), which were mild to moderate and transient in nature.

Conclusion: These data suggest that vardenafil significantly improves erectile function in men with type 1 diabetes and is well tolerated, regardless of the level of glycemic control.