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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Buzelin
J M
JM
Department of Urology, CHU Hôtel-Dieu, Nantes, France.
Roth
S
S
Geffriaud-Ricouard
C
C
Delauche-Cavallier
M C
MC
D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000187:drug effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011187:Posture; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000503:physiopathology; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D016896:Treatment Outcome; D014563:Urodynamics / Q000187:drug effects
D000317:Adrenergic alpha-Antagonists; D003692:Delayed-Action Preparations; D011799:Quinazolines; C047638:alfuzosin