Long-term safety and efficacy of a once-daily formulation of alfuzosin 10 mg in patients with symptomatic benign prostatic hyperplasia: open-label extension study.
OBJECTIVE
To evaluate the long-term safety and efficacy of a new, once-daily (o.d.) prolonged-release formulation of the clinically uroselective alpha1-blocker, alfuzosin, in patients with symptomatic benign prostatic hyperplasia (BPH).


METHODS
This is a 9-month open-label extension of a 3-month double-blind, placebo-controlled evaluation of alfuzosin 10 mg o.d. and standard alfuzosin 2.5 mg, three times daily (t.i.d.), administered without dose titration in both cases. A total of 311 patients continued in the extension phase and all received alfuzosin 10 mg o.d. Efficacy was evaluated in all patients enrolled in the extension phase (n = 311). Safety was assessed in all patients exposed to alfuzosin, whether in the double-blind or extension phase (n = 360).


RESULTS
Mean international prostate symptom score (IPSS) improved significantly, from 17.1 to 9.3 (P < 0.0001), and mean peak flow rate (PFR) (assessed at through plasma levels) increased significantly, from 9.1 to 11.3 ml/s (P < 0.0001), between baseline (i.e. beginning of the double-blind phase) and the endpoint of the extension phase. Quality of life (QOL) index also improved significantly, from 3.3 to 2.1 (P < 0.0001). Alfuzosin was well tolerated, with only 16 of 360 patients (4.4%) reporting adverse events potentially related to alpha-blockade (mainly dizziness). Ejaculation disorders were infrequent (0.6%) and did not show a relationship to treatment. The incidence of asymptomatic orthostatic hypotension was low (2.8%), and no age effect was identified.


CONCLUSIONS
Alfuzosin 10 mg o.d. provides effective relief from BPH, and clinical benefits are maintained up to 12 months. This study also demonstrates the satisfactory long-term safety of this formulation, and its safe use even in at-risk populations.
van Kerrebroec
P
P
Department of Urology, Academisch Ziekenhuis Maastricht, The Netherlands.
Jardin
A
A
van Cangh
P
P
Laval
K U
KU
D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D000369:Aged, 80 and over; D003692:Delayed-Action Preparations / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology*; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000317:Adrenergic alpha-Antagonists; D003692:Delayed-Action Preparations; D011799:Quinazolines; C047638:alfuzosin