C G Roehrborn1, P Van Kerrebroeck, J Nordling. 1. Departments of Urology, The University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA. claus.roehrborn@utsouthwestern.edu
Abstract
OBJECTIVES: To examine the efficacy and safety of a once-daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double-blind, placebo-controlled 3-month studies of patients with lower urinary tract symptoms (LUTS) consistent with clinical benign prostatic hyperplasia. PATIENTS AND METHODS: Patients were randomized to receive alfuzosin, 10 mg once-daily (473) or placebo (482) for 12 weeks. Primary efficacy criteria were improvements in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (PFR). RESULTS:Alfuzosin significantly improved the mean (sd) IPSS, by - 6.0 (5.1) vs - 4.2 (5.7) with placebo (P < 0.005) and the PFR, by + 2.3 (3.8) vs + 1.1 (3.1) ml/s with placebo (P < 0.001), irrespective of prostate size. The significant improvement in LUTS included the irritative and the obstructive subscore of the IPSS and the nocturia criterion; the PFR increased rapidly and significantly, from the first visit (14 days). The quality-of-life score also improved significantly in alfuzosin-treated patients. Alfuzosin was well tolerated; the number of withdrawals for adverse events was comparable in both treatment groups. The most frequently reported adverse event was dizziness (placebo 2.9%, alfuzosin 6.1%). There were no significant changes in blood pressure with alfuzosin compared with placebo, including in elderly and hypertensive patients. Sexual adverse events were rare (abnormal ejaculation, 0.6%). CONCLUSIONS: The once-daily formulation of alfuzosin, administered at 10 mg with no dose titration is effective, with a good safety profile, especially in elderly and hypertensive patients.
RCT Entities:
OBJECTIVES: To examine the efficacy and safety of a once-daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double-blind, placebo-controlled 3-month studies of patients with lower urinary tract symptoms (LUTS) consistent with clinical benign prostatic hyperplasia. PATIENTS AND METHODS: Patients were randomized to receive alfuzosin, 10 mg once-daily (473) or placebo (482) for 12 weeks. Primary efficacy criteria were improvements in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (PFR). RESULTS:Alfuzosin significantly improved the mean (sd) IPSS, by - 6.0 (5.1) vs - 4.2 (5.7) with placebo (P < 0.005) and the PFR, by + 2.3 (3.8) vs + 1.1 (3.1) ml/s with placebo (P < 0.001), irrespective of prostate size. The significant improvement in LUTS included the irritative and the obstructive subscore of the IPSS and the nocturia criterion; the PFR increased rapidly and significantly, from the first visit (14 days). The quality-of-life score also improved significantly in alfuzosin-treated patients. Alfuzosin was well tolerated; the number of withdrawals for adverse events was comparable in both treatment groups. The most frequently reported adverse event was dizziness (placebo 2.9%, alfuzosin 6.1%). There were no significant changes in blood pressure with alfuzosin compared with placebo, including in elderly and hypertensivepatients. Sexual adverse events were rare (abnormal ejaculation, 0.6%). CONCLUSIONS: The once-daily formulation of alfuzosin, administered at 10 mg with no dose titration is effective, with a good safety profile, especially in elderly and hypertensivepatients.
Authors: Casey G Kowalik; Joshua A Cohn; Sophia Delpe; W Stuart Reynolds; Melissa R Kaufman; Doug F Milam; Alan J Wein; Roger R Dmochowski Journal: Rev Urol Date: 2018
Authors: Petros Sountoulides; Marleen M van Dijk; Hessel Wijkstra; Jean J M C H de la Rosette; Martin Christian Michel Journal: World J Urol Date: 2009-10-09 Impact factor: 4.226