Ziegler D et al. (2006) Efficacy and safety of flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction. J Sex Med 3: 883–891

Ziegler et al. have carried out a prospective, randomized study assessing the safety and efficacy of flexible-dose vardenafil therapy in men with type 1 diabetes and erectile dysfunction (ED).

In this double-blind, placebo-controlled study, 302 phosphodiesterase-5-inhibitor-naive men with type 1 diabetes and ED were randomly assigned to receive either flexible-dose vardenafil (5–20 mg, n = 154) or placebo (n = 149) for 12 weeks. The primary outcome measures were patient responses to Sexual Encounter Profile questions regarding successful intercourse—specifically, those relating to vaginal insertion and maintenance of erection. Additional measures included the erectile-function-domain score of the International Index of Erectile Function after 12 weeks of vardenafil treatment or placebo.

The results showed that, at 4, 8, and 12 weeks, the rate of successful vaginal insertion was significantly increased with vardenafil compared with placebo (P <0.0001). Similarly, the mean rate of maintained erections allowing successful intercourse was greater with vardenafil at all time points. Treatment with vardenafil also improved the erectile function domain score (P <0.0001). Vardenafil was well tolerated over the study period. The frequency of adverse effects was low; they included flushing (2.5%) and headaches (3.1%).

The majority of patients in the study had moderate-to-severe ED; the results are, therefore, encouraging for the treatment of ED in men with difficult-to-treat type 1 diabetes.