LONG-TERM TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH ALFUZOSIN - A 24-30-MONTH SURVEY

Objective To address the long-term results of alfuzosin, an alpha(1)-a ntagonist, in patients with benign prostatic hyperplasia (BPH). Patien ts and methods A 6-month, placebo-controlled study involving 518 patie nts was followed by two successive one-year, open extensions. Only cen tres who wished to continue the trial participated in the extensions; 131 patients entered the first extension, with 50 continuing into the second year extension. The results of the second year follow-up are pr esented here. Results Depending on their initial randomization to eith er the placebo or alfuzosin arm, patients were treated with alfuzosin for 24 (n=50) or 30 months (n=22). The data collected on those 50 pati ents in comparison to baseline confirmed that the clinical efficacy ob served in short/medium-term studies was maintained. A clinically signi ficant improvement in urinary symptoms was observed; the Boyarsky scor e decreased from 8.7 (+/-0.3) at baseline to 5.2 (+/-0.3) at 24 months , with no deterioration in the objective parameters. In patients treat ed for 30 months (n= 22), symptomatic assessment and urodynamic parame ters remained stable, indicating the sustained effectiveness of therap y. No serious or unexpected side-effect related to long-term exposure to alfuzosin was observed. No complications associated with BPH occurr ed. Two patients (4%) reported dizziness, neither of whom withdrew fro m the study. In this population, where 40% of patients were receiving concomitant cardiovascular therapy, no clinically significant change i n standing systolic blood pressure, diastolic blood pressure or heart rate was apparent between baseline data and those at 24 months. Conclu sion These data demonstrate the usefulness of long-term treatment with alfuzosin in patients with uncomplicated, moderate BPH.