Sildenafil Effective in Antidepressant-Related Sexual Dysfunction

Laurie Barclay, MD

December 31, 2002

Dec. 31, 2002 — Sildenafil (Viagra) is effective in treating antidepressant-associated sexual dysfunction (AASD), according to the results of a multicenter study reported in the Jan. 1 issue of The Journal of the American Medical Association. Men with sexual dysfunction while taking selective and nonselective serotonin reuptake inhibitors (SRIs) showed significant improvements with sildenafil.

"Our sildenafil study is the first prospective, well-controlled trial to demonstrate significant efficacy and effectiveness of an antidote for treating SRI-AASD," write H. George Nurnberg, MD, from the University of New Mexico School of Medicine in Albuquerque, and colleagues.

Between Nov. 1, 2000, and Jan. 1, 2001, 90 men (mean age, 45 ± 8 years) with major depressive disorder in remission and AASD were randomized to treatment with sildenafil or placebo before sexual activity. Sildenafil dose ranged from 50 to 100 mg. During the six-week trial, 93% of patients received at least one dose of the study drug, and 85% completed six weeks of treatment.

Self-administered tests revealed that 54.5% of patients receiving sildenafil and 4.4% of patients receiving placebo reported being much or very much improved (P < .001). Compared with patients in the placebo group, the sildenafil group improved significantly in erectile function, arousal, ejaculation, orgasm, and overall satisfaction. Mean depression scores did not change significantly during the study.

"The maintained remission of depression supports the importance of maintaining medication adherence by managing treatment-emergent adverse effects to improve treatment outcome," the authors write. "These findings are restricted to the effects of sildenafil on the specific group of men who fulfilled protocol criteria and cannot be generalized to women or other subgroups unless future randomized controlled trials are conducted in those populations."

Pfizer, Inc., supported this study and has financial arrangements with Dr. Nurnberg and other study authors.

JAMA. 2003;289(1):56-64

Reviewed by Michael W. Smith, MD

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