Objectives. To assess the efficacy and safety, and determine the optimal dosage, of a once-daily (OD) formulation of the clinically uroselective alpha₁-blocker, alfuzosin, in patients with lower urinary tract symptoms and symptomatic benign prostatic hyperplasia.

Methods. Five hundred thirty-six patients were randomized to receive alfuzosin (10 mg OD or 15 mg OD), without initial dose titration, or placebo in a 3-month double-blind trial conducted in North America. The primary efficacy criteria were improvement in symptoms (International Prostate Symptom Score) and peak urinary flow rate.

Results. Alfuzosin was significantly more effective than placebo in improving the symptoms and peak urinary flow rate from the first follow-up visit (day 28). The mean change in the International Prostate Symptom Score from baseline at endpoint was −3.6 and −3.4 with alfuzosin 10 mg and 15 mg, respectively, compared with −1.6 with placebo (alfuzosin 10 mg versus placebo, P = 0.001; alfuzosin 15 mg versus placebo, P = 0.004). The median increase in the peak urinary flow rate was +1.1 mL/s and +1.0 mL/s with alfuzosin 10 mg and 15 mg, respectively, compared with 0.0 mL/s with placebo (P = 0.0006 versus placebo for both dose groups). The patients’ quality of life also significantly improved with both alfuzosin doses. Overall, alfuzosin at both doses was well tolerated. The incidence of orthostatic hypotension as determined by systematic blood pressure measurements with both doses of alfuzosin was similar to placebo. No clinically relevant ejaculation disorders were observed with alfuzosin.

Conclusions. Alfuzosin 10 mg OD, administered without dose titration, provides effective relief from the symptoms of benign prostatic hyperplasia with no additional benefit from a 15-mg dose. It is well tolerated from a cardiovascular viewpoint and is not associated with abnormal ejaculation.