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 and effective in the treatment of men with LUTS. To date, the role of varying 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 alfuzosin, 2.5 mg three times daily for 3 months. In phase 2, those patients who had a significant therapeutic response were randomized into one of the following three groups: (1) maintenance of alfuzosin; (2) alfuzosin every other day; and (3) discontinuation of alfuzosin (ie, no treatment). Patients were followed up for a total of 6 months. Parameters of evaluation included the International Prostate Symptom Score (IPSS), global satisfaction, peak urinary flow rate (Qmax), and adverse events. RESULTS: At 3 months, there were 79 patients who were categorized as having obtained a therapeutic response: IPSS decreased to 7.6 +/- 3.2 and Qmax increased to 11.3 +/- 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 3 and 6 months, respectively. Qmax was 12.7 +/- 4.8 and 11.7 +/- 5.2 mL/s for group 1; 12.2 +/- 3.9 and 11.9 +/- 3.7 mL/s for group 2; and 9.7 +/- 2.5 and 9.3 +/- 2.1 mL/s for group 3 at 3 and 6 months, respectively. Global satisfaction at 6 months was the same for groups 1 and 2. There were no differences in adverse events among the three groups. CONCLUSIONS: In men with LUTS who responded to alfuzosin, changing the dosing regimen from daily to once every other day resulted in similar efficacy and safety at 3 and 6 months. By contrast, complete cessation of alfuzosin resulted in recurrence of both symptoms and impaired urinary flow. These data provide evidence that in responding patients, intermittent alpha-blocker therapy may be a reasonable therapeutic regimen. The role of intermittent alpha-blocker therapy using other agents, as well as in a large cohort of men with LUTS, remains to be determined.
RCT Entities:
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 and effective in the treatment of men with LUTS. To date, the role of varying 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 alfuzosin, 2.5 mg three times daily for 3 months. In phase 2, those patients who had a significant therapeutic response were randomized into one of the following three groups: (1) maintenance of alfuzosin; (2) alfuzosin every other day; and (3) discontinuation of alfuzosin (ie, no treatment). Patients were followed up for a total of 6 months. Parameters of evaluation included the International Prostate Symptom Score (IPSS), global satisfaction, peak urinary flow rate (Qmax), and adverse events. RESULTS: At 3 months, there were 79 patients who were categorized as having obtained a therapeutic response: IPSS decreased to 7.6 +/- 3.2 and Qmax increased to 11.3 +/- 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 3 and 6 months, respectively. Qmax was 12.7 +/- 4.8 and 11.7 +/- 5.2 mL/s for group 1; 12.2 +/- 3.9 and 11.9 +/- 3.7 mL/s for group 2; and 9.7 +/- 2.5 and 9.3 +/- 2.1 mL/s for group 3 at 3 and 6 months, respectively. Global satisfaction at 6 months was the same for groups 1 and 2. There were no differences in adverse events among the three groups. CONCLUSIONS: In men with LUTS who responded to alfuzosin, changing the dosing regimen from daily to once every other day resulted in similar efficacy and safety at 3 and 6 months. By contrast, complete cessation of alfuzosin resulted in recurrence of both symptoms and impaired urinary flow. These data provide evidence that in responding patients, intermittent alpha-blocker therapy may be a reasonable therapeutic regimen. The role of intermittent alpha-blocker therapy using other agents, as well as in a large cohort of men with LUTS, remains to be determined.
Authors: Henk van der Worp; Petra Jellema; Ilse Hordijk; Yvonne Lisman-van Leeuwen; Lisa Korteschiel; Martijn G Steffens; Marco H Blanker Journal: BMJ Open Date: 2019-11-07 Impact factor: 2.692