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.
RESULTSAlfuzosin 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%.
CONCLUSIONTreatment 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).