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Vardenafil (Levitra) Provides Sexual Benefits in Diabetic Men with Erectile Dysfunction: Presented at ADA

By Jill Stein

NEW ORLEANS, LA -- June 16, 2003 -- Vardenafil improves the key variables that determine sexual satisfaction in men with coexisting diabetes and erectile dysfunction (ED), researchers announced here on June 13^th at the 63^rd Scientific Sessions of the American Diabetes Association.

Irwin Goldstein, MD, from Boston University, in Massachusetts, United States, presented results in 452 men with type 1 or 2 diabetes and ED for at least 6 months who were randomized to 12 weeks of treatment with placebo, vardenafil 10 mg, or vardenafil 20 mg.

Individuals who had sustained a significant cardiovascular event in the 6 months prior to the study or who had active proliferative retinopathy or retinitis pigmentosa were excluded from the trial. Persons who had used nitrate medications or had undergone a radical prostatectomy for spinal-cord injury or had been unresponsive to sildenafil were also ineligible.

The mean per-patient success rate for vaginal penetration and for sexual intercourse was 64% and 54%, respectively, for the 20-mg dose. Overall, 72% of patients who completed the study and were treated with the 20-mg dose reported improved erections.

Vardenafil 20 mg significantly improved the level of satisfaction with erection hardness, satisfaction with the sexual experience, ability to ejaculate, domains of intercourse satisfaction, and orgasmic function on the International Index of Erectile Dysfunction (IIEF).

Adverse events were those that typically occur with PDE5 inhibitors, and included headache, flushing, rhinitis, and sinusitis.

"In this challenging population of men with ED and diabetes, vardenafil improved key aspects of the sexual experience important to quality of life," Dr. Goldstein said. "In fact, rates of satisfaction and erection hardness were 3 times greater with the 20-mg dose of vardenafil compared to placebo."

Overall, about 50% of men develop erectile dysfunction within 10 years of being diagnosed with diabetes, he added.

This study was carried out at 47 sites in the U.S. and Canada.


[Study title: Vardenafil (Levitra) Improved Satisfaction with Erectile Hardness, Orgasmic Function and Sexual Experience in Men with Diabetes with Erectile Dysfunction. Abstract 68]

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