3-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 a nd prostate surgery up to three years of treatment with alfuzosin. Met hods: Three thousand two hundred and twenty-eight BPH-patients out of 812 centers were included in a prospective three-year open-labelled st udy 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 (Urolif e(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-ni ne patients (79.9%) completed the study at the end of three years. Sym ptom score was significantly reduced by 54% at 3 months and this reduc tion was maintained up to 36 months (-48.4%); HRQL score was significa ntly improved by 45.4% at 12 months and this improvement was maintaine d up to 36 months (+ 43.4%). Alfuzosin was well tolerated: the quantit ative and qualitative distribution of adverse events was similar to th at previously observed in placebo-controlled studies (vertigo/dizzines s: 2.1%). Adverse events accounted for 4.2% of the drop-outs. 120 pati ents (3.7%) were operated on for BPH and nine patients (0.3%) experien ced acute urinary retention. Conclusion: This medical outcomes study c onfirms 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.