CLINICAL UROSELECTIVITY - EVIDENCE FROM PATIENTS TREATED WITH SLOW-RELEASE ALFUZOSIN FOR SYMPTOMATIC BENIGN PROSTATIC OBSTRUCTION

Objective To assess the safety profile of slow-release ISR) alfuzosin in the treatment of benign prostatic obstruction (BPO), with special a ttention to orthostatic blood pressure changes, postural symptoms and efficacy. Patients and methods Two placebo-controlled studies involvin g 588 patients (292 receiving SR alfuzosin 5 mg twice daily and 296 a placebo were pooled; 51% of the patients were greater than or equal to 65 years of age and 43% had associated cardiovascular disease includi ng hypertension and/or were receiving concomitant antihypertensive dru gs. Results SR alfuzosin was very well tolerated with an overall incid ence of adverse events similar to that of placebo (18.5% and 15.8% of patients, respectively) and an overall incidence of withdrawal from th erapy for adverse events lower than that of placebo (3.4% and 5.7%, re spectively). Adverse events potentially related to vasodilatation were infrequent with SR alfuzosin (the same incidence as with placebo, i.e . 2.7% of patients) and these adverse events occurred mainly during th e first month of alfuzosin treatment. The effect on supine blood press ure was minimal. In the subgroups of elderly and hypertensive patients treated with SR alfuzosin, the cumulative incidence of asymptomatic o rthostatic hypotension during the first month of treatment was slightl y higher than with placebo with no objective consequences on the incid ence of adverse events. The clinical efficacy of SR alfuzosin was conf irmed by a significant improvement in urinary symptoms and a significa nt increase in maximum flow rates. Conclusion SR alfuzosin (10 mg/day) can be administered safely without titration in patients with BPO, ev en in elderly and hypertensive patients. Its favourable benefit/risk r atio allows alfuzosin to be classified as a clinically uroselective al pha(1)-blocker. Specific analysis of orthostatic changes in blood pres sure is important when assessing the safety profile of an alpha(1)-blo cker in patients with BPO.