PDE-5 Inhibitors Effective in Women
Sildenafil can ease the adverse sexual effects of antidepressant treatment, according to researchers.
Off-label use of sildenafil (Viagra) relieved the sexual side effects of antidepressants for women in a recent clinical trial.
Those side effects included lack of arousal, sensation, or lubrication and orgasm delay—common occurrences with both selective and nonselective serotonin reuptake inhibitors (SRIs).
“Treatment-associated sexual dysfunction is a principal reason for a risk of nonadherence and leads to increased relapse, recurrence, disability, and resource utilization by affected patients,” the research says.
Previous studies of selective phosphodiesterase type 5 (PDE-5) inhibitors, such as sildenafil, have been limited to men, and the FDA has not approved these drugs for women.
This study, led by H. George Nurnberg, MD, professor of psychiatry at the University of New Mexico School of Medicine in Albuquerque, randomly divided 98 women into two equal groups. They were then assigned to take sildenafil or placebo an hour or two before anticipated sexual activity. Dosage was adjustable, ranging between 50 and 100 mg.
All participants were in remission from major depression but continuing on SRI therapy to avoid relapse or recurrence. With a median age of 37 years, they were premenopausal and had been sexually functional before starting SRI treatment. All had experienced persistent sexual dysfunction for at least a month before the trial began.
After eight weeks, the sildenafil group had a mean Clinical Global Impression score of 1.9 compared with 1.1 among the placebo group. Only 28% of the women taking sildenafil said they had no improvement compared with 73% in the placebo arm.
Headache, flushing, and dyspepsia were frequently re-ported, but they were not severe enough to cause any participant to quit the trial. Findings appear in The Journal of the American Medical Association (2008;300:395-404).
“[Our ability to treat] this bothersome treatment-associated adverse effect in patients who have been effectively treated for depression but need to continue on their medication to avoid relapse or recurrence,” the authors wrote, “[will allow] patients to remain antidepressant-adherent, reduce the current high rates of premature medication discontinuation, and improve depression disease management outcomes.”
The researchers also noted that their findings are important not only because women experience major depression disorder at nearly twice the rate of men and experience greater resulting sexual dysfunction, but because the data establish that selective PDE-5 inhibitors are effective in both sexes.