Finasteride reduces the risk of incident clinical benign prostatic hyperplasia.

BACKGROUND Despite the high prevalence of clinical benign prostatic hyperplasia (BPH) among older men, there remains a notable absence of studies focused on BPH prevention. OBJECTIVE To determine if finasteride prevents incident clinical BPH in healthy older men. DESIGN, SETTING, AND PARTICIPANTS Data for this study are from the Prostate Cancer Prevention Trial. After excluding those with a history of BPH diagnosis or treatment, or an International Prostate Symptom Score (IPSS) ≥ 8 at study entry, 9253 men were available for analysis. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was incident clinical BPH, defined as the initiation of medical treatment, surgery, or sustained, clinically significant urinary symptoms (IPSS >14). Finasteride efficacy was estimated using Cox proportional regression models to generate hazards ratios (HRs). RESULTS AND LIMITATIONS Mean length of follow-up was 5.3 yr. The rate of clinical BPH was 19 per 1000 person-years in the placebo arm and 11 per 1000 person-years in the finasteride arm (p<0.001). In a covariate-adjusted model, finasteride reduced the risk of incident clinical BPH by 40% (HR: 0.60; 95% confidence interval, 0.51-0.69; p<0.001). The effect of finasteride on incident clinical BPH was attenuated in men with a body mass index ≥ 30 kg/m(2) (p(interaction) = 0.04) but otherwise did not differ significantly by physical activity, age, race, current diabetes, or current smoking. The post hoc nature of the analysis is a potential study limitation. CONCLUSIONS Finasteride substantially reduces the risk of incident clinical BPH in healthy older men. These results should be considered in formulating recommendations for the use of finasteride to prevent prostate diseases in asymptomatic older men.