Mirabegron Safe, Effective for Overactive Bladder in the Elderly
Phase 4 trial showed that mirabegron significantly decreased incontinence episodes and micturitions compared with placebo among patients aged 65 years and older.
PHILADELPHIA—Mirabegron is a safe and effective treatment for overactive bladder (OAB) in older patients, a researcher reported at the International Continence Society's 2018 annual meeting.
Adrian Wagg, MB, BS, of the University of Alberta in Edmonton, presented findings from a 12-week phase 4 prospective, randomized, placebo-controlled trial that enrolled 888 patients older than 65 years who had OAB symptoms for 3 months or more. The mean age of the patients was about 72 years. The proportion of patients older than 75 years was 28% among mirabegron and placebo recipients.
Investigators randomly 445 patients to receive mirabegron and 443 to receive placebo. Among the mirabegron patients, 226 received 25 mg and 219 opted to titrate to mirabegron 50 mg by the end of the study. From baseline to end of treatment, mirabegron-treated patients experienced significantly greater declines in the mean number of incontinence episodes per 24 hours (˗2.06 vs ˗1.57) and mean number of micturitions per 24 hours (˗2.5 vs ˗2.0) compared with placebo recipients, based on 3-day micturition diaries.
The mean volume voided per micturition increased significantly more among mirabegron-treated patients than placebo recipients (32.44 vs 18.49 mL). The mirabegron group also experienced a significantly greater decrease in mean OAB-q symptom bother scores (˗23.39 vs ˗18.69).
Except for improvement in 24-hour micturition frequency, escalation to mirabegron 50 mg was not clearly associated with additional benefit, according to the investigators.
Mirabegron was well tolerated, and no unexpected adverse events over those previously reported in phase 3 trials were observed.
Wagg A, Staskin D, Engel E, et al. A phase 4, double-blind, randomized, placebo-controlled, parallel group, multi-centre study to evaluate the efficacy, safety, and tolerability of mirabegron in older adult patients with overactive bladder syndrome (PILLAR). Data presented at the International Continence Society's 2018 annual meeting in Philadelphia, August 28-31. Abstract 268.