"We found that over 12 weeks of treatment, vardenafil significantly improved standard measures of erectile dysfunction," said Hermann van Ahlen, MD, professor of urology, University of Muenster, Muenster, Germany, in a presentation on June 11^th. "And, importantly, it was safe for this population. This should be encouraging news for these patients, who suffer a high incidence of erectile dysfunction."

This randomised, placebo-controlled study enrolled 318 men not previously treated with vardenafil or sildenafil.

After a 4-week treatment-free run-in period, the researchers randomised subjects to vardenafil 10 mg (5 mg greater than or equal to 65 years) or placebo, with an option to titrate to 5 mg or 20 mg after each 4-week period.

Endpoints were successful vaginal insertion (SEP2) and maintenance of erection for successful intercourse (SEP3) over 12 weeks of treatment.

Secondary endpoints included the International Index of Erectile Function-erectile function (IIEF-EF) domain score.

The investigators also gathered data on adverse events to determine safety.

Of subjects randomised to vardenafil (n = 163) or placebo (n = 155), 273 completed the study.

At baseline more than 34% of all subjects had hemoglobin A1c > 8%. Baseline comorbidities included cardiovascular comorbidities (51%) and nervous system (31%) comorbidities.

Vardenafil demonstrated statistically significant (P < .0001) superiority over placebo in both SEP2 (70% vs 49%) and SEP3 (51% vs 26%).

At 12 weeks, mean IIEF-EF scores increased from 12.6 to 20.3, a significant improvement compared with placebo (P < .0001).

The proportion of men with IIEF-EF scores > 25 was also significantly higher for vardenafil subjects at all evaluations (P < .0001), and reached a rate of 40% (vardenafil) versus 9% (placebo) at trial endpoint.

The researchers reported that glycaemic control did not appear to have an impact on the clinical effectiveness of vardenafil.

Most adverse events among vardenafil subjects were mild to moderate, with headache (3%) and flushing (2%) reported most frequently.

Vardenafil is safe, efficacious, and clinically superior to [placebo] in men with erectile dysfunction with varying degrees of glycaemic control, the authors concluded.


[Presentation title: Efficacy and Safety of the Phosphodiesterase Type-5 Inhibitor Vardenafil in Men With Erectile Dysfunction and Type 1 Diabetes Mellitus. Abstract 435-P]

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