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Sildenafil (Viagra) Well Tolerated in Men With Comorbid Depression: Presented at AANP

By Bonnie Darves

ANAHEIM, CA -- July 4, 2003 -- Men who have erectile dysfunction (ED) and mild to moderate depression appear to respond well to sildenafil (Viagra), according to a new study presented here July 2^nd at the American Academy of Nurse Practitioners annual meeting.

Because ED and depression often occur concurrently, and depression may be untreated prior to start of treatment with sildenafil, the study was conducted to assess whether sildenafil would be safe and efficacious in light of the depression diagnosis.

Researchers at the Institute for Male Urology in Los Angeles, California, and The Male Clinic in Beverly Hills, California, United States, enrolled 146 men with diagnosed ED and diagnosed but untreated depression, defined as a mean score of 16.9 on the Hamilton Depression Rating Scale (HAM-D).

Patients received either a flexible dose of sildenafil or placebo for 12 weeks. In the randomized, double-blind trial, men who had been diagnosed with ED at least 6 months earlier and who had HAM-D scores of 12 or greater were assessed at baseline and end point for sexual function and HAM-D changes. The median duration of treatment was 84 days; dosing ranged from 25 mg to 100 mg an average of 3 times weekly; 79% of the treatment group took the 100-mg dose. Treatment response was assessed at 8 and 12 weeks.

"There are some questions out there as to whether patients [with depression] would really respond to ED therapy -- and that's why we did the study," said chief author Christopher Forest, PA, director of clinical trials at The Male Clinic. "Even in mild to moderate depression, we found that the patients responded tremendously to the erectile-dysfunction therapy."

The study found that 91% of subjects who received sildenafil reported improved erections, compared with 11% of those on placebo, and treated men also reported higher frequency of successful intercourse attempts. Most adverse events in the treatment group -- primarily headache, dyspepsia, and flushing -- were mild and transient in nature. One patient dropped out of the study because of adverse events.

Forest said he and coauthors did expect that some patients with depression would respond well to the therapy, given that men's sex drive tends to supersede other factors.

The study was funded by Pfizer Inc.


[Study title: Efficacy And Safety Of Sildenafil. Poster IND-16 7/2]

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