Early symptom improvement of benign prostatic hyperplasia (BPH) treated with once daily alfuzosin.
OBJECTIVE
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 < or = 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.
Saad
Fred
F
Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Nickel
J Curtis
JC
Valiquette
Luc
L
Casey
Richard
R
Kuzmarov
Irwin
I
Elhilali
Mostafa
M
D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D014555:Urination Disorders / Q000188:drug therapy
D000317:Adrenergic alpha-Antagonists; D003692:Delayed-Action Preparations; D011799:Quinazolines; C047638:alfuzosin