Three-year safety and efficacy data on the use of finasteride in the treatment of benign prostatic hyperplasia.
OBJECTIVE
To assess the long-term safety and efficacy of finasteride in the treatment of symptomatic benign prostatic hyperplasia in patients treated with finasteride 5 mg for thirty-six months.


METHODS
Two large multicenter studies were used. Patients were randomly assigned to treatment with finasteride, 1 or 5 mg, or placebo for twelve months. After completing twelve months of therapy, patients were invited to enter an open extension to the study in which all patients received finasteride 5 mg. Urinary symptoms, urinary flow rate, prostate volume, and serum concentrations of prostate-specific antigen and dihydrotestosterone were measured periodically during the study.


RESULTS
After thirty-six months of treatment with finasteride 5 mg, prostate volume was reduced from baseline by approximately 27 percent, maximum urinary flow rate improved by approximately 2.3 mL/second, and symptom scores improved by 3.6 points. Forty-two percent of patients had a 30 percent or greater decrease in prostate volume, 40 percent of patients showed an increase of 3 mL/second or more in maximum urinary flow rate, and 48 percent of patients experienced a 50 percent or greater improvement in symptom scores. Finasteride was well tolerated and there was no evidence of increased adverse experiences with increased duration of treatment.


CONCLUSIONS
The excellent safety profile and sustained clinical efficacy, over thirty-six months, of daily treatment with finasteride 5 mg recommend finasteride as a low-risk medical option for the treatment of symptomatic benign prostatic hyperplasia.
Stoner
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Merck Research Laboratories, Rahway, New Jersey.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D013196:Dihydrotestosterone / Q000097:blood; D004311:Double-Blind Method; D018120:Finasteride / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000187:drug effects / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D011471:Prostatic Neoplasms / Q000150:complications; D012720:Severity of Illness Index; D014563:Urodynamics / Q000187:drug effects
D013196:Dihydrotestosterone; D018120:Finasteride; D017430:Prostate-Specific Antigen