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Title: Vardenafil Can Improve Erectile Function in Diabetic Men Who Do Not Respond to Sildenafil: Presented at ADA

"Vardenafil Can Improve Erectile Function in Diabetic Men Who Do Not Respond to Sildenafil: Presented at ADA"

By Jill Stein ORLANDO, FL -- June 7, 2004 -- Vardenafil (Levitra), a potent and selective PDE5 inhibitor, lessens the severity of erectile dysfunction in diabetic men who do not respond to sildenafil, reported researchers. On June 5[^th, Culley Carson, MD, with the University of North Carolina in Chapel Hill, United States, presented at the 64^th Scientific Sessions of the American Diabetes Association (ADA) results of a multicentre, double-blind study in which 463 diabetic men had been randomised to 4 weeks' of treatment with vardenafil, 10 mg, or placebo. Subjects had the option to maintain or titrate their dosage based on efficacy and tolerability after each of 2 consecutive 4-week intervals.

Participants in the study were 18 years of age or older with erectile dysfunction as defined by the National Institute of Health Consensus Statement. All were sildenafil non-responders by history, which was defined by 6 rigorous criteria including no response to 100 mg sildenafil.

Study end points included the 30-point erectile function (EF) domain score and responses to the Global Assessment Question (GAQ): "Has the treatment you have been taking over the past four weeks improved your erections?"

The vardenafil and placebo groups were well balanced with respect to age, body mass index, mean duration of erectile dysfunction diagnosis, etiology of erectile dysfunction, severity of erectile dysfunction, and history of hypertension, benign prostastic hyperplasia, and coronary artery disease.

The mean enrollment EF domain scores for vardenafil and placebo groups were 9.7/10.0, respectively, reflecting severe erectile dysfunction.

Results showed that vardenafil was superior to placebo on both efficacy measures. Vardenafil increased mean EF scores to 15.1, or moderately severe erectile dysfunction, and GAQ response rates were 59%.

Vardenafil was generally well tolerated.

"More than 50 percent of diabetic men develop erectile dysfunction within ten years of being diagnosed with diabetes, and erectile dysfunction tends to be less responsive to treatment in diabetic men," Dr. Carson said. "The efficacy of vardenafil in this challenging –to-treat patient population may improve patient satisfaction with oral erectile dysfunction therapy."

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