INTRODUCTION AND OBJECTIVES: A novel slow release formulation of alfuzosin should improve compliance by reducing dosing to one 10 mg tablet per day. The current study examined efficacy, at 9 days and 3 months, and safety of this formulation of alfuzosin in BPH patients.
METHODS: ALF-X was a 3-month, non-comparative, observational study of 353 BPH patients from 39 Canadian Urology centres.
Results: At baseline (BL), mean age was 63.1±9.01 years, 92.6% of patients were Caucasian, 3.4% had a history of acute urinary retention, mean duration of the micturition disorder was 48.6±54.15 months, and mean PSA was 3.3±6.65 ng/mL. Mean total International Prostate Symptom Score (I-PSS) decreased from 17.5 at BL to 10.4 at M3 - an improvement of 7.1±6.82 points (40.6%, p<0.001), mostly occurring (27.0%, p<0.001)) during the first 9 days. Mean Quality of Life Assessment Index improved by 0.7±1.39 points between BL and D9 (17.5%, p<0.001), and by 1.5±1.52 points between BL and M3 (37.5%, p<0.001). The proportion of 'mild' I-PSS patients increased from 11.8% (BL) to 29.7% (D9) to 39.0% (M3); those with 'severe' I-PSS decreased from 37.8% (BL) to 14.5% (D9) to 9.4% (M3). Of 144 patients with nocturia (>2 nightly voidings) at D1, 51.4% improved to <2 nightly voidings at D9, and 60.4% at M3. Adverse events related to alfuzosin occurred in 7.8% of patients; 2.0% experienced serious adverse events. There were no vasodilatory events related to alfuzosin or deaths.
CONCLUSIONS: In routine clinical practice, slow-release alfuzosin is associated with a significant improvement in LUTS, and frequency of nocturia, and an excellent safety profile.