OBJECTIVE: To address the long-term results of alfuzosin, an alpha 1-antagonist, in patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: A 6-month, placebo-controlled study involving 518 patients was followed by two successive one-year, open extensions. Only centres 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 presented here. RESULTS: Depending on their initial randomization to either 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 patients in comparison to baseline confirmed that the clinical efficacy observed in short/medium-term studies was maintained. A clinically significant improvement in urinary symptoms was observed; the Boyarsky score 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 treated for 30 months (n = 22), symptomatic assessment and urodynamic parameters remained stable, indicating the sustained effectiveness of therapy. No serious or unexpected side-effect related to long-term exposure to alfuzosin was observed. No complications associated with BPH occurred. Two patients (4%) reported dizziness, neither of whom withdrew from the study. In this population, where 40% of patients were receiving concomitant cardiovascular therapy, no clinically significant change in standing systolic blood pressure, diastolic blood pressure or heart rate was apparent between baseline data and those at 24 months. CONCLUSION: These data demonstrate the usefulness of long-term treatment with alfuzosin in patients with uncomplicated, moderate BPH.
RCT Entities:
OBJECTIVE: To address the long-term results of alfuzosin, an alpha 1-antagonist, in patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: A 6-month, placebo-controlled study involving 518 patients was followed by two successive one-year, open extensions. Only centres 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 presented here. RESULTS: Depending on their initial randomization to either 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 patients in comparison to baseline confirmed that the clinical efficacy observed in short/medium-term studies was maintained. A clinically significant improvement in urinary symptoms was observed; the Boyarsky score 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 treated for 30 months (n = 22), symptomatic assessment and urodynamic parameters remained stable, indicating the sustained effectiveness of therapy. No serious or unexpected side-effect related to long-term exposure to alfuzosin was observed. No complications associated with BPH occurred. Two patients (4%) reported dizziness, neither of whom withdrew from the study. In this population, where 40% of patients were receiving concomitant cardiovascular therapy, no clinically significant change in standing systolic blood pressure, diastolic blood pressure or heart rate was apparent between baseline data and those at 24 months. CONCLUSION: These data demonstrate the usefulness of long-term treatment with alfuzosin in patients with uncomplicated, moderate BPH.