Dutasteride Prevents Clinical Progression of Benign Prostatic Hyperplasia in Minimally Symptomatic Men

The 5α-reductase inhibitor dutasteride is used to treat men with symptomatic benign prostatic hyperplasia (BPH). Investigators assessed whether dutasteride prevents clinical progression of BPH in minimally symptomatic men with enlarged prostate glands.

The study involved 1600 men with prostate gland size >40 cc and International Prostate Symptom Score (IPSS) <8 at baseline who were randomized to receive daily dutasteride (0.5 mg) or placebo for 4 years. Overall, the composite outcome (urinary retention, acute urinary tract infection, BPH-related surgery, or a ≥4-point increase in IPSS) developed significantly more often in men who received placebo than in men who received dutasteride (36% vs. 21%), yielding a number needed to treat of 7. Com…