Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia

OBJECTIVE To evaluate the efficacy and safety of two doses (10 and 15 mg) of alfuzosin once daily and tamsulosin (0.4 mg) once daily, compared with placebo, in men with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS In this randomized, double-blind, placebo-controlled, multicentre study, 625 patients were randomized to receive alfuzosin 10 or 15 mg once daily, tamsulosin 0.4 mg once daily (active reference), or matching placebo for 12 weeks, with no initial dose titration. The study was designed to compare each of the three active treatments with the placebo group. Primary outcome measures were mean changes from baseline in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (Q(max)) at 12 weeks, compared with placebo, using one-way analysis of variance. Because Q(max) data were not normally distributed, median changes from baseline were also compared for Q(max). Pair-wise comparisons were conducted using the Dunnett correction for quantitative variables and Bonferroni-Holm correction for categorical variables, allowing for multiple treatment group comparisons. RESULTS Alfuzosin 10 mg significantly improved urinary tract symptoms compared with placebo, with a mean (sd) change from baseline in the IPSS of - 6.5 (5.2) vs - 4.6 (5.8) for placebo (adjusted P = 0.007); there was a trend toward a difference between alfuzosin 15 mg, with a mean (sd) change from baseline in IPSS of - 6.0 (5.6), and placebo (adjusted P = 0.050). The mean change from baseline in IPSS with tamsulosin 0.4 mg, at - 6.5 (5.6), vs placebo was also significant (adjusted P = 0.014). The median change from baseline in Q(max) was significantly increased with both alfuzosin doses and with tamsulosin (all adjusted P = 0.02 vs placebo). Both doses of alfuzosin were well tolerated, with dizziness the most frequent adverse event (placebo, 4%; alfuzosin 10 mg, 6%; 15 mg, 7%; tamsulosin, 2%); the respective incidence rates of sexual function adverse events were 0%, 3%, 1% and 8%. CONCLUSION Treatment with alfuzosin 10 mg significantly improved urinary symptoms and Q(max) compared with placebo and was well tolerated. There were also significant improvements over placebo with the active reference, tamsulosin 0.4 mg. The incidence of sexual function adverse events was higher with tamsulosin than with placebo. The benefit-to-risk profile of alfuzosin 10 mg once daily appeared to be reduced with a higher dose (15 mg).