Efficacy and safety of a new prolonged release formulation of alfuzosin 10mg once daily versus alfuzosin 2.5 mg thrice daily and placebo in patientswith symptomatic benign prostatic hyperplasia

Objectives: To assess the efficacy and safety of a new prolonged release fo rmulation of the uroselective alpha(1)-blocker alfuzosin for a once-daily d osing regimen in patients with lower urinary tract symptoms (LUTS) suggesti ve of symptomatic benign prostatic hyperplasia (BPH). Methods: After a 1-month run-in period, 447 patients were randomly allocate d in a double-blind placebo-controlled study to receive alfuzosin 10 mg onc e daily (n = 143), alfuzosin 2.5 mg thrice daily (n = 150) or placebo (n = 154) for 3 months. At inclusion, 46% of the randomised population had conco mitant cardiovascular disease and 30% received an antihypertensive treatmen t. Uroflowmetry was performed close to trough plasma concentration of alfuz osin once daily to demonstrate the 24-hour coverage with this formulation. Results: Both alfuzosin formulations significantly improved urinary symptom s versus placebo assessed using the International Prostate Symptom Score (a lfuzosin 10 mg once daily: -6.9; alfuzosin 2.5 mg thrice daily: -6.4; place bo: -4.9, p = 0.005). Peak flow rate increased significantly with alfuzosin 10 mg once daily (+2.3 ml/s, p = 0.03 vs. placebo) and with alfuzosin 2.5 mg thrice daily (+3.2 ml/s, p<0.0001 vs. placebo) compared to placebo (+1.4 ml/s). Overall both formulations of alfuzosin were well tolerated in compa rison with placebo. In addition, vasodilatory adverse events appeared to be less frequent with the once daily than the thrice daily formulation (6.3 v s. 9.4%, respectively). No first-day effect was reported with alfuzosin onc e daily and the effect on blood pressure did not differ from those observed in placebo, both in normotensive and hypertensive patients. No specific se xual dysfunction including ejaculation disorder was reported in the alfuzos in 10 mg once-daily group, Conclusion: The new once-daily formulation of alfuzosin administered at a d ose of 10 mg daily is an effective 24-hour treatment of LUTS associated wit h BPH. Alfuzosin is as effective as the immediate formulation and shows a b etter cardiovascular safety. The better safety profile enables the same dos e to be used in all patients, providing the patients with the benefits of a once-daily administration. Copyright (C) 2000 S. Karger Ag, Basel.