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Vardenafil Provides Sustained Improvement of Erectile Dysfunction in Men with Diabetes: Presented at ADA

By Jill Stein

SAN FRANCISCO, CA -- June 16, 2002 -- New data confirm the long-term safety and efficacy of vardenafil treatment for erectile dysfunction (ED) in diabetic men.

Up to 50 percent of men with diabetes develop ED within ten years of diagnosis, and these patients represent a difficult-to-treat population.

The new findings from a double-blind, randomized trial, show that vardenafil is safe and effective for at least six months in men with type 1 or 2 diabetes and ED of at least six months duration. The study was presented here Friday at the 62^nd Scientific Sessions of the American Diabetes Association (ADA),

Dr. Irwin Goldstein, with Boston University Medical Center in Boston, Massachusetts, United States, and colleagues elsewhere, randomized patients to receive 10 mg or 20 mg of vardenafil, taken as needed but no more than once a day.

All trial participants had been in a stable heterosexual relationship for more than six months. The trial excluded patients who had developed ED after spinal cord injury and patients who had undergone a radical prostatectomy or had retinitis pigmentosa or angina. Men who had discontinued the use of sildenafil due to adverse effects or a lack of efficacy were also ineligible for enrollment.
Increases in erectile function (EF) domain scores were similar within each treatment group after three months and six months of treatment.

Patients receiving vardenafil 10 mg or 20 mg at randomization remained on therapy for the entire six months.

A total of 340 men continued into the extension phase of the trial. Overall, 55 and 51 placebo-treated men were converted to 10 mg and 20 mg vardenafil, respectively. In the treatment group, 118 and 116 men remained on 10 mg and 20 mg, respectively.

After three and six months, men on 10 mg and 20 mg increased EF domain scores by similar degrees for all three efficacy measures -- EF domain scores, erection maintenance success rates, and a global assessment question of improved erections. For all three efficacy variables, patients who started on placebo reported improvement in erectile function when placed on 10 mg or 20 mg treatment, similar to those who had been on six months of treatment.

Overall, 73 percent of patients reported improved erections with the 20 mg dose.

Vardenafil was well tolerated. Adverse events were dose-related, transient, and mostly mild to moderate in severity. The most frequent drug-related adverse events after six months of treatment with vardenafil were flushing (11 percent) and headache (10 percent). Drug-related adverse events in the three-month extension were 3 percent for flushing and 2 percent for headache.

In another study presented at the ADA meeting, researchers reported that vardenafil safely improved key indices of ED in diabetic men, independent of the degree of glycemic control, permitting up to 72 percent of patients to achieve improved erections.

The study was sponsored by Bayer Corporation in West Haven, Connecticut, United States.

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