Sildenafil reduced the adverse sexual effects related to treatment with serotonin reuptake inhibitors in women who had major depression in remission in a randomized trial of 98 women.
“These findings are important not only because women experience major depressive disorder at nearly double the rate of men and because they experience greater resulting sexual dysfunction than men, but also because [they established] that selective phosphodiesterase type 5 inhibitors are effective” for reducing adverse sexual effects in women, Dr. H. George Nurnberg of the department of psychiatry, University of New Mexico Health Sciences Center, Albuquerque, and his associates said in a report in JAMA.
The researchers compared sildenafil with placebo in an 8-week randomized clinical trial with 98 premenopausal women who had major depressive disorder in remission. The participants in the study, which was supported by Pfizer Inc., reported persistent sexual dysfunction and had been taking selective or nonselective SRIs for a mean of 27 months.
Treatment efficacy was assessed using four measures: the Clinical Global Impressions Scale adapted for sexual function, the Sexual Function Questionnaire, the Arizona Sexual Experience Scale (female version), and the University of New Mexico Sexual Function Inventory (female version).
At the end of treatment, women in the sildenafil group reported a greater ability to reach orgasm and to experience orgasm satisfaction than did those in the placebo group. They also were more likely to report improvements in arousal, vaginal lubrication, and orgasm delay, the last of which “is considered a central feature of SRI-associated sexual dysfunction,” the investigators said.
“Clinically, 73% of women taking placebo, compared with 28% of women taking sildenafil, reported no improvement with treatment,” Dr. Nurnberg and his associates said (JAMA 2008;300:395–404).
There were no serious adverse events. The most common minor adverse events were headache (affecting 43% of the sildenafil group and 27% of the placebo group), flushing (24% vs. 0%), dyspepsia (12% vs. 0%), nasal congestion (37% vs. 6%), and transient visual disturbances (14% vs. 2%).
Treating the sexual dysfunction that affects up to 70% of women treated with SRIs should encourage patients to adhere to antidepressant therapy and thus improve outcomes, the researchers added.
Dr. Nurnberg has received research support from, has been a paid consultant for, and has been on speakers bureaus for various pharmaceutical companies that manufacture antidepressants.