Safety and efficacy of sustained-release alfuzosin on lower urinary tract symptoms suggestive of benign prostatic hyperplasia in 3,095 Spanish patients evaluated during general practice.

Abstract

This general practitioner-run study assess the security as well as the efficacy and impact on health-related quality of life of a sustained-release (SR) form of alfuzosin in Spanish patients suffering from lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). 3,095 patients with symptomatic BPH were enrolled into a national, multicentric, open, phase IV observational study. The period of active treatment studied (5 mg, twice daily) was 60 days. Safety was assessed by monitoring blood pressure and spontaneous adverse events. Symptoms were assessed using a validated Spanish International Prostate Symptom Score (I-PSS). Impact of symptoms on health-related quality of life was assessed using the quality of life index (L). 101 adverse events were reported in 82 patients (2.6%). 28 adverse events (2.6%) were classified as severe. 49 patients (1.6%) dropped out of the study due to adverse events but only 17 of these patients (0.5%) showed adverse events related to vasodilation. Incidence of postural events (vertigo, postural hypotension/hypotension, headache and dizziness) was low (55 patients, 1.8%) and effects on sexual function were found not significant: no retrograde ejaculation was reported and only 1 patient (0.03%) showed impotence. Blood pressure or heart rate showed no clinically significant changes. All the I-PSS scores decreased significantly during the treatment with alfuzosin, improvement being excellent in 60% of the patients. Symptomatic improvement was associated with a significant improvement in health-related quality of life. This large study conducted during general practice on Spanish BPH patients confirms the efficacy on LUTS and good safety profile of SR alfuzosin, especially its low incidence of postural symptoms and no deleterious effect on sexual function.