3-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 patien ts treated with finasteride 5 mg for thirty-six months. Methods. Two l arge 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 en ter an open extension to the study in which all patients received fina steride 5 mg. Urinary symptoms, urinary flow rate, prostate volume, an d serum concentrations of prostate-specific antigen and dihydrotestost erone were measured periodically during the study. Results. After thir ty-six months of treatment with finasteride 5 mg, prostate volume was reduced from baseline by approximately 27 percent, maximum urinary flo w rate improved by approximately 2.3 mL/second, and symptom scores imp roved 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 evide nce of increased adverse experiences with increased duration of treatm ent. 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 treatm ent of symptomatic benign prostatic hyperplasia.