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


METHODS
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.


RESULTS
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.


CONCLUSIONS
Compared with placebo, men treated with finasteride experienced new drug-related sexual AEs with an increased incidence only during the first year of therapy.
Wessells
Hunter
H
University of Washington, Seattle, Washington, USA.
Roy
Johnny
J
Bannow
John
J
Grayhack
John
J
Matsumoto
Alvin M
AM
Tenover
Lisa
L
Herlihy
Richard
R
Fitch
William
W
Labasky
Richard
R
Auerbach
Stephen
S
Parra
Raul
R
Rajfer
Jacob
J
Culbertson
Jennifer
J
Lee
Michael
M
Bach
Mark A
MA
Waldstreicher
Joanne
J
D000368:Aged; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D007172:Erectile Dysfunction / Q000139:chemically induced / Q000453:epidemiology; D018120:Finasteride / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D012720:Severity of Illness Index; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology*
D004791:Enzyme Inhibitors; D018120:Finasteride