CAN FINASTERIDE REVERSE THE PROGRESS OF BENIGN PROSTATIC HYPERPLASIA - A 2-YEAR PLACEBO-CONTROLLED STUDY

Objectives. To study if placebo-induced improvement in men with sympto matic benign prostatic hyperplasia (BPH) is maintained over 2 years, a nd to study the efficacy and safety from intervention with finasteride 5 mg for 24 months. Methods. This was a multicenter, double-blind, pl acebo-controlled study involving 707 patients with moderate symptoms o f BPH enrolled at 59 centers in five Scandinavian countries. Following enrollment and a 4-week single-blind placebo run-in period, patients were randomized to receive finasteride 5 mg once daily or placebo for 24 months. Urinary symptoms, urinary flow rate, prostate volume, postv oiding residual urinary volume, and serum concentrations of prostate-s pecific antigen together with laboratory safety parameters were measur ed at entry and at months 12 and 24. Interim physical and laboratory e xaminations were performed when indicated clinically. Results. In fina steride-treated patients the total symptom score improved throughout t he study, with a significant difference between the two groups at 24 m onths (P less than or equal to 0.01), whereas in placebo-treated patie nts, there was an initial improvement in the symptom score but no chan ge from baseline at 24 months. The maximum urinary flow rate decreased in the placebo group, but improved in the finasteride group, resultin g in a between-group difference of 1.8 mL/s at 24 months (P less than or equal to 0.01). The mean change in prostate volume was +12% in the placebo group versus -19% in the finasteride-treated group (P < 0.01). Finasteride was generally well tolerated throughout the 2-year study period. Conclusions. The efficacy of therapy with finasteride 5 mg in improving both symptoms and maximum urinary flow rate and reducing pro state volume has been shown to be maintained during 24 months while pa tients receiving placebo experienced a return to baseline or deteriora tion of these parameters during the study. These results demonstrate t hat finasteride can reverse the natural progression of BPH.