The efficacy and safety of a new once-a-day formulation of an alpha-blocker.

Objectives: To assess the long-term efficacy and safety of alfuzosin 10 mg OD in patients with symptomatic BPH.
Methods: Patients (>50 years) were randomised to alfuzosin 10 mg OD, alfuzosin 2.5. mg t.i.d. or placebo for 3 months. Open-label alfuzosin 10 mg OD was continued for up to 1 year. Efficacy assessments included the International Prostate Symptom Score (I-PSS) and quality of life index and uroflowmetry.
Results: At 3 months, there was a significant reduction in I-PSS and a significant improvement in peak flow rate for both alfuzosin groups compared with placebo (p < 0.05). Vasodilatory adverse experiences were more common in the alfuzosin 2.5 mg group than the 10 mg OD group. Improvements in symptoms and flow rate with alfuzosin 10 mg OD were maintained for up to 12 months.
Conclusion: Alfuzosin 10 mg OD is an effective treatment for symptomatic BPH for at least 12 months, with a better cardiovascular safety profile than the immediate release formulation.