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Title: Vardenafil Effectively Improves Erectile Dysfunction and Depression Following Radical Nerve-Sparing Prostatectomy: Presented at AAPA

"Vardenafil Effectively Improves Erectile Dysfunction and Depression Following Radical Nerve-Sparing Prostatectomy: Presented at AAPA"

By Paul D. Thacker NEW ORLEANS, LA -- May 29, 2003 -- Results of a study of 29 men with erectile dysfunction and depression showed that both erectile dysfunction and depression were improved by daily vardenafil 20 mg. Investigators reported results of a randomized, placebo-controlled, double-blind phase III trial here at the AAPA Annual Physician Assistant Conference. Vardenafil, a phosphodiesterase-5 inhibitor similar to sildenafil (Viagra), is used to treat erectile dysfunction in Europe. Although not yet approved for use in the United States, "this drug is currently under review by the [Food and Drug Administration]," said Michael Stengel, a physician assistant with Bayer. Following nerve-sparing radical prostatectomy, the 29 subjects were identified as having erectile dysfunction and depression. Depression was measured with the Center for Epidemiology Studies-Depression Scale (CES-D) and was defined as CES-D score of greater than 16. The subjects were randomized to vardenafil 20 mg or placebo. At the start of the study, mean CES-D was 19.6 for the vardenafil group and 20.05 for the placebo group. After 12 weeks of daily treatment, subjects taking vardenafil showed significant improvements versus placebo in erectile function and in depression scores (CES-D mean of 10.82 versus 17.82; P<0.05). "This compares favorably with other studies on depression and erectile dysfunction," said Mr. Stengel. "Whenever you improve erectile dysfunction, you also see an improvement in depression. You just can't tell which is the cause and which is the effect." He added that the study could have been improved if more people had been included. This study was sponsored by Bayer. [Study title: Influence of Vardenafil, a Potent, Highly Selective Phosphodiesterase-5 Inhibitor, on Improving Erectile Function and Depressive Symptomatology in Patients with Erectile Dysfunction Secondary to Radical Nerve-Sparing Prostatectomy.]

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