[Prospective follow-up of 3,228 patients suffering from clinical benign prostatic hyperplasia (BPH) treated for 3 years wi alfuzosin in general practice. BPH Group in General Practice]

Abstract

Objective: To determine (a) the amplitude and duration of reduction of the symptom score and improvement of the HRQL score (including sexual function), (b) the adverse effects and (c) the incidence of acute urinary retention and prostatic surgery during the 3 years of alfuzosin treatment.

Material and methods: 3,228 patients suffering from BPH were included by 812 centers in a 3-year open prospective study and were treated with alfuzosin (immediate release) at the recommended dosage. A symptom score (modified Boyarsky) and a specific HRQL score, comprising 20 items including 3 questions on sexuality (Urolifetm BPH Qol20) were self-administered on inclusion and after 3, 6, 12, 18, 24, 30 and 36 months.

Results: 2,579 patients (79.9%) completed the 3 years of the study. The symptom score was significantly decreased by 54% at 3 months and this reduction was maintained until 36 months (-48.4%); the HRQL score was significantly improved by 45.4% at 12 months and this improvement was maintained until 36 months (+43.4%). Alfuzosin was well tolerated: the qualitative and quantitative distribution of adverse effects was identical to that previously observed in placebo-controlled trials (vertigo-dizziness: 2.1%). Adverse effects were responsible for 4.2% of drop-outs from the trial. 120 patients (3.7%) were operated for BPH and 9 patients (0.3%) developed acute urinary retention.

Conclusion: This prospective study confirms the long-term safety of use of alfuzosin under routine general practice conditions and emphasizes the need to measure HRQL in the context of the patient's opinion.