| Abstrakt: |
Background: Urinary symptoms, including overactive bladder (OAB), are seen in up to 80% of patients with multiple sclerosis (MS). Most antispasmodics for OAB are anticholinergic, which may worsen cognition and constipation in MS. Mirabegron, approved for OAB in the general population, is a B3 adrenergic agonist, so it may be better tolerated in patients with MS. Objectives: To assess safety, tolerability, and efficacy of mirabegron in treating OAB in MS. Methods: Twenty-eight patients with MS and OAB were randomized 1:1 into placebo and treatment arms of this double-blind, placebo-controlled 10-week study. All patients received pelvic floor exercise training and watched a video about behavioral management of OAB. Patients in the control arm received placebo while the treatment arm received mirabegron (25 mg) with optional uptitration to 50 mg. Seventy-two--hour voiding diaries were used. The primary outcome measure was the change in OAB Symptom Composite Score (OAB-SCS), which assesses voiding frequency and urgency; higher scores mean worse symptoms. Secondary measures included number and volume of micturition, incontinence episodes, and patient assessments of OAB severity. Results: While both groups' scores were lower at final visit than at baseline, the final daily average OAB-SCS for the mirabegron group was 0.47 higher than that of the placebo group (95% CI = 0.047, 0.893, P = .031). Thus, the mirabegron group had a worse primary outcome. On the other hand, for Subject Global Impression, the mirabegron group rated overall bladder control as significantly better relative to the placebo group (95% CI = 0.375, 2.381, P = .009). Trends suggesting treatment-related improvement in other secondary measures favored mirabegron on number of micturition and incontinence episodes per day, but these and other secondary outcomes did not reach statistical significance. Adverse events were limited and similar between groups, and there were no serious adverse events. Drug adherence was about 95%. Conclusions: Mirabegron was safe and well-tolerated in this MS population. Our mixed results do not demonstrate benefit from adding mirabegron to a program of behavior modification for OAB. Patients with MS may have neurologic differences from a general OAB population that reduce the responsiveness to beta-3 adrenergic agonists. A larger study population may elucidate the extent of the treatment effect on bladder function in patients with MS. [ABSTRACT FROM AUTHOR] |
