Vardenafil Improves Erectile Function After Prostatectomy

Laurie Barclay, MD

September 24, 2002

Sept. 25, 2002 — Vardenafil (Levitra) reduces erectile dysfunction (ED) and may prevent depression in men who have had nerve-sparing prostatectomy, according to a presentation on Sept. 23 at the 10th World Congress of the International Society for Sexual and Impotence Research held in Montreal, Quebec, Canada. A second presentation suggests that the drug maintains its efficacy with repeated use.

"Men who suffer from ED following prostatectomy are among the most difficult to treat because their ED is typically severe," lead author Gerald Brock, MD, from St. Joseph's Health Centre in London, Ontario, Canada, says in a news release. "The finding that Levitra significantly improved erectile function in our study patients is important because more than two-thirds of these men had severe ED."

Vardenafil is a potent and highly selective PDE5 inhibitor. In this double-blind study, 440 men with persistent ED for six months or more after nerve-sparing retropubic radical prostatectomy were randomized to treatment with placebo, vardenafil 10 mg, or vardenafil 20 mg for 12 weeks. Age range was 44 to 77 years, and baseline Erectile Function (EF) domain scores were 9.1 to 9.3, indicating that ED was generally severe.

After 12 weeks, EF domain scores improved to 15.3 with both vardenafil doses but remained at 9.2 with placebo ( P<.0001). Erections improved in 65% of men taking 20 mg vardenafil, in 59% of men taking 10 mg vardenafil, and in 12.5% of men taking placebo ( P<.0001).

Vardenafil 20 mg improved depressive symptoms as measured with the Duke Health Profile ( P<.05 vs. placebo). In the subgroup of men with Center for Epidemiologic Studies-Depression (CES-D) scale scores of 16 or greater, indicating depression at baseline, improvement was significantly better with vardenafil 20 mg than with placebo (posttreatment scores, 10.8 vs. 17.9, P<.001).

"The finding that Levitra eased depressive symptoms in these men is very good news, because it means that Levitra helps improve quality of life in men who are often suffering both emotionally and physically from this condition," Brock says.

The most common drug-related adverse events were mild or moderate, including headache, cutaneous flushing, and rhinitis.

A separate study showed that vardenafil maintained reliable efficacy over time in a broad population of men with ED. In this phase III, double-blind trial, 805 men with ED were randomized to treatment with vardenafil 5 mg, 10 mg, 20 mg, or placebo for up to 26 weeks. In the group taking 20 mg, 74% of first attempts at intercourse resulted in penetration, compared with 46% of men in the placebo group. Of those men taking vardenafil who achieved penetration on their first attempt at intercourse, 91% continued to do so on subsequent attempts.

"Men want to be confident that the ED drug they are taking works the first time and time after time," says lead author Luc Valiquette, MD, from the Hospital Saint-Luc du CHUM in Montreal. "I've seen frustration in some of my patients because the current treatments do not consistently work, and their efficacy may diminish over time. This reinforces the need for new oral ED therapies that are effective, consistent and safe."

10th World Congress of the ISSIR. Sept. 23, 2002.

Reviewed by Gary D. Vogin, MD


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