Safety, efficacy, and persistence of long‐term mirabegron treatment for overactive bladder in the daily clinical setting: I nterim (1‐year) report from a J apanese post‐marketing surveillance study

Objectives To report interim 1‐year results from a 3‐year surveillance study evaluating safety, efficacy, and persistence of long‐term mirabegron for overactive bladder ( OAB ). Methods Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions ( ADR ), changes in OAB symptoms, changes in O veractive B ladder S ymptom S core ( OABSS ), and treatment discontinuations. Treatment persistence rates were calculated by Kaplan–Meier analysis. Results Eighty‐one ADR were observed in 72/1139 patients (6.3%) through 1 year of mirabegron treatment, with the incidence highest during the first month. No significant change in residual urine volume was observed at any observation point up to 1 year of mirabegron treatment. Mirabegron was deemed “effective” in 883/1091 patients (80.9%) at 1 year/discontinuation. Total OABSS was decreased with statistical significance at 3, 6 months, and 1 year, or at discontinuation ( P  < 0.001 at each time point). Kaplan–Meier treatment persistence rates were 84.8% at 3 months, 77.6% at 6 months, and 66.0% at 1 year. Treatment persistence rates were similar for male and female patients but significantly higher for patients aged ≥65 years (67.3%; n  = 908) compared with those aged <65 years (59.8%; n  = 231; log‐rank test: P  = 0.032). Conclusions Long‐term OAB treatment with mirabegron was well‐tolerated, with effectiveness maintained through 1 year. Mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years.