Three-year prospective study of 3228 clinical BPH patients treated with alfuzosin in General Practice

Objectives: To investigate (a) the magnitude and durability of symptom score reduction and HRQL score improvement (including sexual drive); (b) adverse outcomes; and (c) progression to acute urinary retention and prostate surgery up to three years of treatment with alfuzosin. Methods: Three thousand two hundred and twenty-eight BPH-patients out of 812 centers were included in a prospective three-year open-labelled study and treated with alfuzosin (immediate release formulation) at the recommended dosage. A symptom score (Boyarsky modified) and a 20-item BPH specific HRQL score including three questions of sexuality (Urolife(TM) BPH QoL 20) were self-administered at baseline, 3, 6, 12, 18, 24, 30, and 36 months. Results: Two thousand five hundred and seventy-nine patients (79.9%) completed the study at the end of three years. Symptom score was significantly reduced by 54% at 3 months and this reduction was maintained up to 36 months (-48.4%); HRQL score was significantly improved by 45.4% at 12 months and this improvement was maintained up to 36 months (+ 43.4%). Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events was similar to that previously observed in placebo-controlled studies (vertigo/dizziness: 2.1%). Adverse events accounted for 4.2% of the drop-outs. 120 patients (3.7%) were operated on for BPH and nine patients (0.3%) experienced acute urinary retention. Conclusion: This medical outcomes study confirms the long-term safety profile of alfuzosin in the naturalistic conditions of general practice and highlights the need to measure HRQL in the context of patient's preferences.