PROSCAR(R) - 5-YEAR EXPERIENCE

We assessed the long-term safety and efficacy of finasteride, an orall y active Sa-reductase inhibitor, in 2, previously reported groups of p atients with symptomatic benign prostatic hyperplasia (BPH). Prostate volume was measured by magnetic resonance imaging, and the maximum uri nary flow rate was assessed noninvasively. Symptoms were scored utiliz ing a patient self-administered symptom score questionnaire. Total sym ptom scores ranged from 0 (or asymptomatic) to 35 (severely symptomati c). After an initial double-blind period, the patients in study 1 were treated with 10 mg finasteride for 1 year and then switched to 5 mg f inasteride for an additional 4 years, whereas patients in study 2 were treated with 5 mg finasteride for the entire 5 years. A total of 190 patients were randomized in the double-blind studies, 156 entered year 1 of the open extension and 70 patients completed 5 years of finaster ide therapy. In both studies prostate volume was reduced from baseline by 30%, dihydrotestosterone was reduced by 72%, and the maximum urina ry flow rate improved by approximately 1.5 ml/s. Prostate-specific ant igen was decreased by approximately 50%. Finasteride was well tolerate d approximately 10% of patients reported sexual adverse experiences du ring the 5-year study period, which were considered drug related by th e investigators. The incidence in reporting sexual adverse experiences did not increase with the increased duration of treatment: findings c onsistent with previous reports. In summary, treatment of BPH with fin asteride for 5 years inhibits the progression of the disease with an e xcellent safety profile and represents a low-risk medical option for t he treatment of symptomatic BPH.