Objective: To assess the safety profile of slow-release (SR) alfuzosin in the treatment of benign prostatic obstruction (BPO), with special attention to orthostatic blood pressure changes, postural symptoms and efficacy.
Patients and methods: Two placebo-controlled studies involving 588 patients (292 receiving SR alfuzosin 5 mg twice daily and 296 a placebo) were pooled; 51% of the patients were > or = 65 years of age and 43% had associated cardiovascular disease including hypertension and/or were receiving concomitant antihypertensive drugs.
Results: SR alfuzosin was very well tolerated with an overall incidence of adverse events similar to that of placebo (18.5% and 15.8% of patients, respectively) and an overall incidence of withdrawal from therapy for adverse events lower than that of placebo (3.4% and 5.7%, respectively). 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 the first month of alfuzosin treatment. The effect on supine blood pressure was minimal. In the subgroups of elderly and hypertensive patients treated with SR alfuzosin, the cumulative incidence of asymptomatic orthostatic hypotension during the first month of treatment was slightly higher than with placebo with no objective consequences on the incidence of adverse events. The clinical efficacy of SR alfuzosin was confirmed by a significant improvement in urinary symptoms and a significant increase in maximum flow rates.
Conclusion: SR alfuzosin (10 mg/day) can be administered safely without titration in patients with BPO, even in elderly and hypertensive patients. Its favourable benefit/risk ratio allows alfuzosin to be classified as a clinically uroselective alpha 1-blocker. Specific analysis of orthostatic changes in blood pressure is important when assessing the safety profile of an alpha 1-blocker in patients with BPO.