Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: A pooled analysis of three double-blind, placebo-controlled studies

OBJECTIVES: To examine the efficacy and safety of a once-daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double-blind, placebo-controlled 3-month studies of patients with lower urinary tract symptoms (LUTS) consistent with clinical benign prostatic hyperplasia. PATIENTS AND METHODS: Patients were randomized to receive alfuzosin, 10 mg once-daily (473) or placebo (482) for 12 weeks. Primary efficacy criteria were improvements in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (PFR). RESULTS: Alfuzosin significantly improved the mean (SD) IPSS, by -6.0 (5.1) vs -4.2 (5.7) with placebo (P < 0.005) and the PFR, by +2.3 (3.8) vs +1.1 (3.1) ml/s with placebo (P < 0.001), irrespective of prostate size. The significant improvement in LUTS included the irritative and the obstructive subscore of the IPSS and the nocturia criterion; the PFR increased rapidly and significantly, from the first visit (14 days). The quality-of-life score also improved significantly in alfuzosin-treated patients. Alfuzosin was well tolerated; the number of withdrawals for adverse events was comparable in both treatment groups. The most frequently reported adverse event was dizziness (placebo 2.9%, alfuzosin 6.1%). There were no significant changes in blood pressure with alfuzosin compared with placebo, including in elderly and hypertensive patients. Sexual adverse events were rare (abnormal ejaculation, 0.6%). CONCLUSIONS: The once-daily formulation of alfuzosin, administered at 10 mg with no dose titration is effective, with a good safety profile, especially in elderly and hypertensive patients.