Efficacy and safety of sustained-release alfuzosin 5 mg in patients with benign prostatic hyperplasia. ALGEBI Study Group.

Abstract

To assess the efficacy and safety of a sustained-release (SR) formulation of alfuzosin, a selective alpha(1)-blocker, in patients with symptomatic benign prostatic hyperplasia (BPH). A total of 390 men were randomly assigned to receive SR-alfuzosin (n = 194), 5 mg twice daily without dose titration, or placebo (n = 196) for 12 weeks. Of the patients included, 47% had concomitant cardiovascular disease, mainly hypertension or coronary heart disease. SR-alfuzosin significantly improved urinary symptoms versus placebo assessed using the I-PSS (-31 vs. -18%, p = 0.007) and Boyarsky (-30 vs. -16%, p < 0.001) scores, with a direct correlation between both scores. Maximum flow rate increased significantly with SR-alfuzosin (+2.4 ml/s, i.e. +29%) compared with placebo (+1.1 ml/s, i.e. +14%, p = 0.006). Residual urine was also significantly reduced with SR-alfuzosin. Overall, SR-alfuzosin was as well tolerated as placebo. Nine patients dropped out for adverse events with SR-alfuzosin (4.6%) and 14 (7.1%) with placebo. The incidence of vasodilation-related events (dizziness, postural symptoms, headache) with SR-alfuzosin (3.1%) was similar to that of placebo (3.6%). No first-dose effect was observed compared with placebo. The reduction in supine blood pressure with SR-alfuzosin was minor (< or = 5 mm Hg), both in normotensive and hypertensive patients. SR-alfuzosin is an effective treatment of symptoms related to BPH that shows a good safety profile in normotensive and hypertensive patients, without the need of dose titration.