MAINTENANCE OF CLINICAL EFFICACY WITH FINASTERIDE THERAPY FOR 24 MONTHS IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA

Background: Finasteride, a 5 alpha-reductase inhibitor, has been shown to have beneficial effects in the treatment of benign prostatic hyper plasia. The long-term safety and efficacy of finasteride in the treatm ent of benign prostatic hyperplasia was assessed. Methods: In two mult icenter, double-blind, placebo-controlled studies (North American and international), patients with symptomatic benign prostatic hyperplasia were randomly assigned to receive finasteride, 1 or 5 mg, or placebo for 1 year followed by an open-extension study in which all patients w ere treated with finasteride, 5 mg, regardless of original therapy. Me n aged 40 to 80 years, in good physical and mental health, were eligib le to enter the study. All patients were to have a maximum urinary flo w rate of 15 mL/s or less with a voided volume of 150 mL or more, an e nlarged prostate, and symptoms of urinary obstruction. Patients with a prostate-specific antigen level of 40 mg/mL or more or any finding su ggestive of prostate cancer were excluded. Results: Two hundred ninety -eight patients received finasteride, 5 mg, continuously for 24 months . At the end of 24 months of finasteride therapy, the median prostate volume was reduced by 25%, and 60% of patients had a 20% or greater re duction in prostate volume. Maximum urinary flow rate was improved by at least 2 mL/s, and symptoms were improved by approximately 3.5 point s. Decreased libido and ejaculation disorders were the only drug-relat ed adverse experiences reported in more than 1% of patients. Conclusio n: These studies support the long-term safety and tolerability of fina steride, while demonstrating its continuing clinical efficacy in the t reatment of patients with symptomatic benign prostatic hyperplasia.