INTERMITTENT ALPHA-BLOCKER THERAPY IN THE TREATMENT OF MEN WITH LOWERURINARY-TRACT SYMPTOMS

Objectives. To determine the safety and efficacy of intermittent alpha -blocker therapy in men with lower urinary tract symptoms (LUTS) in a prospective study. Alpha-blockers have been demonstrated to be safe an d effective in the treatment of men with LUTS. To date, the role of va rying dosing regimens in responding patients has not been well studied . Methods. Men with LUTS were entered into this prospective open label , parallel, randomized trial. In phase 1, patients were treated with a lfuzosin, 2.5 mg three times daily for 5 months. In phase 2, those pat ients who had a significant therapeutic response were randomized into one of the following three groups: (1) maintenance of alfuzosin; (2) a lfuzosin every other day; and (3) discontinuation of alfuzosin (ie, no treatment). Patients were followed up for a total of 6 months. Parame ters of evaluation included the International Prostate Symptom Score ( IPSS), global satisfaction, peak urinary flow rate (Qmax), and adverse events. Results. At 5 months, there were 79 patients who were categor ized as having obtained a therapeutic response: IPSS decreased to 7.6 +/- 5.2 and Qmax increased to 1 1.3 +/- 2.9 mL/s. After randomization, IPSS was 7.1 +/- 2.9 and 6.5 +/- 2,5 for group 1; 6.5 +/- 3.2 and 6.7 +/- 2.1 for group 2; and 11.4 +/- 4.8 and 12.3 +/- 4.9 for group 3 at 5 and 6 months, respectively. Qmax was 12.7 +/- 4.8 and 1 1.7 +/-. 5. 2 mL/s for group 1; 12.2 +/- 5.9 and 11.9 +/- 5.7 mL/s for group 2; an d 9.7 +/- 2.5 and 9.5 +/- 2. 1 mL/s for group 5 at 5 and 6 months, res pectively. Global satisfaction at 6 months was the same for groups 1 a nd 2. There were no differences in adverse events among the three grou ps. Conclusions. In men with LUTS who responded to alfuzosin, changing the dosing regimen from daily to once every other day resulted in sim ilar efficacy and safety at 3 and 6 months. By contrast, complete cess ation of alfuzosin resulted in recurrence of both symptoms and impaire d urinary flow. These data provide evidence that in responding patient s, intermittent alpha-blocker therapy may be a reasonable therapeutic regimen. The role of intermittent alpha-blocker therapy using other ag ents, as well as in a large cohort of men with LUTS, remains to be det ermined. (C) 1998, Elsevier Science Inc. All rights reserved.