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ADA: Vardenafil Improves Erectile Function In Diabetics By Jill Stein Special to DG News PHILADELPHIA, PA -- June 24, 2001 -- The new highly selective phosphodiesterase 5 (PDE5) inhibitor, vardenafil, is highly effective in improving erectile function in diabetic men with mild to severe erectile dysfunction (ED). These findings come from phase III data presented at the 61st Scientific Sessions of the American Diabetes Association (ADA) yesterday (June 23) by Dr. Jerome Fischer and co-workers with the Diabetes and Glandular Disease Research Group in San Antonio, Texas. The researchers randomized 452 diabetic men to 12 weeks’ treatment with either placebo or 10 mg or 20 mg vardenafil tablets on demand but not more than once a day. Fifty-four of the men enrolled in the trial had type 1 diabetes, and 398 had type 2 diabetes. Subjects had mild to severe ED, defined as ED of greater than six months’ duration. The trial excluded patients with a history of significant cardiac events in the prior six months or progressive proliferative retinopathy or retinitis pigmentosa. Patients who had previously used nitrates or who had undergone prostatectomy were also excluded. Primary efficacy variables were the ED domain of the International Index of Erectile Function (IIEF) and the per-patient success rates for both erectile penetration and maintaining erections to complete intercourse by event diary. A Global Assessment Question (GAQ) was also used to evaluate patients who completed the study. The question was: "Has the treatment you have been taking over the past four weeks improved your erections?" Vardenafil significantly improved erections, as assessed by the GAQ, and erectile function as assessed by the IIEF Erectile Function domain. Vardenafil also significantly improved penetration as well as maintenance to intercourse completion. The adverse event profile was consistent with a selective PDE5 inhibitor. Headache was the most prominent adverse event. E-mail this page to a friend or colleague! To print, use this version