Objectives: To evaluate the efficacy and adverse effects of alfuzosin for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
Methods: The included studies were randomized controlled trials involving men with symptomatic BPH treated with alfuzosin versus placebo or active control for at least 4 weeks.
Results: The search strategy identified 11 trials involving 3901 men with a mean age of 64 years. Eight trials were placebo-controlled studies, two were alfuzosin versus alternative alpha-blockers, and one was alfuzosin versus finasteride and combination alfuzosin/finasteride therapy. The study durations were short term, 4 to 26 weeks. The mean baseline symptom scores and peak urinary flow rates were indicative of moderate BPH. Alfuzosin (7.5 or 10 mg) improved lower urinary tract symptoms assessed by the International Prostate Symptom Score compared with placebo. The mean absolute change from baseline was -5.4 points for alfuzosin compared with -3.6 points for placebo, a weighted mean difference of 1.8 points (three studies). Alfuzosin increased the peak urinary flow more than did placebo, although the improvement varied across the eight studies. Symptom and flow improvements were generally comparable to that with combination therapy and with other alpha1-blockers. Alfuzosin had good short-term tolerability, and the numbers of study withdrawals were comparable to those with placebo and controls. Efficacy and short-term safety were similar across the various (immediate-release, sustained, and once-daily) formulations.
Conclusions: The results from short-term studies have indicated that alfuzosin improves lower urinary tract symptoms and urinary flow more than does placebo and is generally well tolerated in men with symptomatic BPH. Long-term efficacy and safety studies in combination with a 5-alpha-reductase inhibitor should be initiated.