Objectives: To assess the 3-year efficacy and safety of the selective alpha(1)-blocker alfuzosin at 10 mg once daily in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in 'real-life practice'. The influence of treatment response on the risk of acute urinary retention (AUR) and BPH-related surgery was also analysed.
Patients and methods: In all, 689 European men (mean age 67.6 years) were enrolled by general practitioners in a 3-year open-label study with alfuzosin at 10 mg once daily. They were asked to complete the International Prostate Symptom Score (IPSS), its eighth question (bother score), and the Danish Prostatic Symptom Score for sexual function (DAN-PSSsex). Efficacy was analysed at the endpoint in the intent-to-treat population. The impact of baseline variables (age, PSA level, IPSS and bother severity) and dynamic variables (IPSS worsening of >or=4 points and bother at the last available assessment under treatment) on the risk of AUR and BPH-related surgery was evaluated.
Results: With alfuzosin, IPSS improved by 6.4 points (-33.4%) from baseline (P < 0.001), reaching >or=3 points and >6 points in 71.3% and 47.2% of men, respectively. There were also significant (P < 0.001) improvements from baseline in nocturia (-0.8, -25.5%), bother score (-1.7, -40.7%) and DAN-PSSsex weighted scores with treatment. Symptom relief was rapid and maintained over 3 years. Overall, 78 men (12.4%) had an IPSS worsening of >or=4 points, 16 (2.6%) had AUR, and 36 (5.7%) required BPH-related surgery. Symptom deterioration during treatment and high baseline PSA values were the best predictors of AUR and BPH-related surgery. Alfuzosin was well tolerated, dizziness being the most frequent adverse event (4.5%) possibly related to vasodilatation. Ejaculatory disorders were uncommon (0.4%). Changes in blood pressure remained marginal, including in men aged >or=65 years and those receiving antihypertensive agents.
Conclusion: Alfuzosin administered for 3 years at 10 mg once daily in real-life practice is effective and well tolerated. High PSA values and symptom worsening under treatment appear the best predictors of AUR and BPH-related surgery in the long term. Treatment with alfuzosin might thus help to identify patients at risk of LUTS/BPH progression in order to optimize their management.