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Vardenafil Improves Erectile Function Following Radical Prostatectomy: Presented at EAU

BIRMINGHAM, ENGLAND -- February 26, 2002 -- In the first clinical study of its kind examining the use of drug therapy to improve erectile function in men who had undergone nerve-sparing radical prostatectomy, patients taking vardenafil reported statistically significant improvement in erectile function.

Among men who had undergone bilateral nerve-sparing surgery, 71 percent of those taking vardenafil 20 mg experienced improved erections.

Vardenafil is an investigational treatment for erectile dysfunction (ED) discovered by Bayer AG and will be co-promoted and co-developed with GlaxoSmithKline plc (GSK). Vardenafil is being evaluated in a broad range of patient populations, including difficult-to-treat patients.

The new data, presented at the 17^th Annual Congress of the European Association of Urology (EAU), are important because at least one third of men with prostate cancer who undergo nerve-sparing radical prostatectomy experience ED. Since 1991, radical prostatectomy has been the most common treatment for localized and regional cancers(1). According to the American Cancer Society, 189,000 new cases of prostate cancer will be diagnosed this year.

"Men who have had a radical prostatectomy generally experience very severe ED, as was seen in this study population," said Gerald Brock, MD, Associate Professor, Department of Surgery, Division of Urology at St. Joseph's Health Care in London, Ontario, Canada. "The response rates seen in this study are impressive considering the severe level of ED."

The multi-center, randomised, double-blind, placebo-controlled, fixed-dose prospective study was designed to evaluate the effect of vardenafil (a phosphodiesterase-5 [PDE-5] inhibitor) on erectile function as compared to placebo in men who had undergone either unilateral or bilateral nerve-sparing radical retropubic prostatectomy six months to five years prior to screening.

The majority of men (70 percent) enrolled in the study presented with severe ED.

Following a four-week baseline period, 444 men were randomised to treatment with vardenafil 10 mg, vardenafil 20 mg or placebo for 12 weeks. Participants were evaluated using the erectile function (EF) domain of the International Index of Erectile Function (IIEF), a standard sexual function questionnaire used by urologists that includes questions about the ability to achieve and maintain erections to the completion of sexual intercourse.

Participants were also asked to track success in partner penetration and ability to maintain an erection in a patient diary. In addition, the global assessment question (GAQ) was used for those men completing the 12-week study to evaluate if patients experienced improved erections.

Patients at all ED severity levels -- mild, moderate, severe - taking vardenafil 10 or 20 mg reported statistically significant improvement in erectile function. Results showed that nearly half of men reported successful penetration compared to only 22 percent in the placebo group (p<0.0001). An almost four-fold increase in the ability to maintain an erection was reported compared with the placebo group (p<0.0001). Both doses of vardenafil were significantly superior to placebo for the EF domain score.

In the 20 mg group, 65 percent of patients reported improved erections compared to 13 percent in the placebo group (p<0.0001). Among the men with severe ED, a seven-fold improvement in successful intercourse was reported.

The most commonly reported drug related adverse events were headache, flushing and nasal congestion.

Erectile dysfunction -- the inability to sustain an erection sufficient for sexual intercourse -- is a major medical condition among men that is largely untreated. There are a number of causes for ED, including prostatectomy, medical conditions, such as diabetes and cardiovascular disease, as well as psychological factors. Although ED affects an estimated 30 million men in the United States(2), research shows only 11 percent of men are being treated for the condition(3), demonstrating the clear need for additional therapies in this area.

Vardenafil is a PDE-5 inhibitor being researched and developed by Bayer. Its clinical development program to date has included eight phase III trials involving approximately 4,000 patients. In a published phase III study in a broad population, up to 85 percent of patients taking vardenafil reported statistically significant improvements in erectile function versus placebo (4).

A new drug application for vardenafil was submitted in September 2001 and accepted for filing by the U. S. Food and Drug Administration (FDA). In November 2001, Bayer and GSK signed a worldwide co-promotion agreement for vardenafil. Vardenafil has been submitted for regulatory review for marketing approval in all major regions worldwide, including the United States, Europe and Japan.

References:

(1) Data from National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program.

(2) Massachusetts Male Aging Study.

(3) Vardenafil market research.

(4) W.J.G. Hellstrom, et al., Int. J. Imp. Res. 2001: 13 Suppl 5: S65

SOURCE: GlaxoSmithKline plc and Bayer Corporation

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