Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia

• Published in: Urology (Ridgewood, N.J.) Vol. 61; no. 3; pp. 579 - 584
• Main Authors: Wessells, Hunter, Roy, Johnny, Bannow, John, Grayhack, John, Matsumoto, Alvin M, Tenover, Lisa, Herlihy, Richard, Fitch, William, Labasky, Richard, Auerbach, Stephen, Parra, Raul, Rajfer, Jacob, Culbertson, Jennifer, Lee, Michael, Bach, Mark A, Waldstreicher, Joanne
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.03.2003; Elsevier Science
• Subjects: Aged; Antineoplastic agents; Biological and medical sciences; Chemotherapy; Double-Blind Method; Enzyme Inhibitors - adverse effects; Enzyme Inhibitors - therapeutic use; Erectile Dysfunction - chemically induced; Erectile Dysfunction - epidemiology; Finasteride - adverse effects; Finasteride - therapeutic use; Humans; Incidence; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Placebo Effect; Prostatic Hyperplasia - drug therapy; Severity of Illness Index; Sexual Dysfunctions, Psychological - chemically induced; Sexual Dysfunctions, Psychological - diagnosis; Sexual Dysfunctions, Psychological - epidemiology; Antineoplastic agent; Human; Urinary system disease; Finasteride; Prostate disease; Antiandrogen; Adenoma; Antihormone; Azasteroid; Incidence; Chemotherapy; Randomization; Controlled environment study; Treatment; Placebo; Secondary effect; Double blind study; Benign neoplasm; Male genital diseases; Prostate; Comparative study; Male sexual function
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/S0090-4295(02)02401-9

To evaluate the incidence and resolution of sexual adverse experiences (AEs) in men with benign prostatic hyperplasia treated with finasteride 5 mg compared with placebo. The Proscar Long-term Efficacy and Safety Study (PLESS) was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men, aged 45 to 78 years, with symptomatic benign prostatic hyperplasia, enlarged prostates, and no evidence of prostate cancer. Patients completed a questionnaire at screening regarding their history of sexual dysfunction. During treatment, spontaneously self-reported sexual AEs were recorded. At screening, 46% of patients in each treatment group reported some history of sexual dysfunction. During year 1 of the study, 15% of finasteride-treated patients and 7% of placebo-treated patients had sexual AEs that were considered drug related by the investigator ( P <0.001). During years 2 to 4, no between-group difference was noted in the incidence of new sexual AEs (7% in each group). The drug-related sexual AE profile for finasteride was similar for men with or without a history of sexual dysfunction. Sexual AEs resolved while continuing therapy in 12% of finasteride patients and 19% of placebo patients. Only 4% of finasteride and 2% of placebo patients discontinued the study because of sexual AEs. In men who discontinued with a sexual AE, 50% and 41% experienced resolution of their sexual AE after discontinuing finasteride or placebo therapy, respectively. Compared with placebo, men treated with finasteride experienced new drug-related sexual AEs with an increased incidence only during the first year of therapy.