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Vardenafil Improves Sexual Satisfaction in Impotent Diabetic Men, Regardless of Glycaemic Control: Presented at IDF
By Jill Stein
PARIS, FRANCE -- August 25, 2003 -- Vardenafil (Levitra) improves key measures of patient satisfaction in diabetic men with erectile dysfunction irrespective of glycaemic control.
This finding was reported on August 25th at the Eighteenth International Diabetes Federation Congress (IDF).
Vardenafil is a highly selective and potent phosphodiesterase type 5 inhibitor.
Dr. Irwin Goldstein, with Boston University in Massachusetts, United States, presented the results of a double-blind, fixed-dose trial. The researchers enrolled 452 men who had been randomised to 12 weeks' treatment with vardenafil, 10 mg or 20 mg, or placebo following a 4-week unmedicated run-in period. All participants had type 1 or 2 diabetes and erectile dysfunction that had been present for at least 6 months.
The trial excluded men who had sustained a cardiac event in the prior 6 months or used nitrates. Patients with active proliferative retinopathy or retinitis or were unresponsive to sildenafil were also ineligible.
Irrespective of glycaemic control, vardenafil 10 mg and 20 mg significantly improved satisfaction rates of erection hardness and sexual experience compared to placebo.
Similarly, irrespective of glycaemic control, vardenafil 10 and 20 mg improved the International Index of Erectile Function-Erectile Function (IIEF-EF) Domain scores for intercourse satisfaction, orgasmic function, and overall satisfaction compared to placebo.
Treatment-related side effects were infrequent, generally mild to moderate, and transient.
Dr. Goldstein said that the findings are impressive since they demonstrate that vardenafil is a worthwhile treatment for a challenging population. "Research shows that diabetes dramatically increases by 3-fold the prevalence rates of erectile dysfunction," he noted. "Also, because the prevalence of erectile dysfunction increases with duration, poor control, and complications of diabetes such as vascular and microvascular disease and neuropathies, men with erectile dysfunction are more difficult to treat."
The study, conducted at 47 sites in the U.S. and Canada, was sponsored by Bayer Incorporated in Toronto, Canada.
[Study title: Vardenafil (Levitra) improved patient satisfaction with erectile hardiness, orgasmic function and sexual experience in men with erectile dysfunction and diabetes irrespective of level of glycaemic control. Abstract 917]
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