Objectives: To assess the efficacy and safety of a sustained-release (SR) formulation of alfuzosin, a selective ai-blocker, in patients with symptomatic benign prostatic hyperplasia (BPH). Methods: A total of 390 men were randomly assigned to receive SR-alfuzosin (n = 194), 5 mg twice daily without dose titration, or placebo (n = 196) for 12 weeks. Of the patients included, 47% had concomitant cardiovascular disease, mainly hypertension or coronary heart disease. Results: SR-alfuzosin significantly improved urinary symptoms versus placebo assessed using the I-PSS (-31 vs. -18%, p = 0.007) and Boyarsky (-30 vs. -16%, p