Kato D, et al. – This study was undertaken to present interim 1–year results from a 3–year surveillance study evaluating safety, adequacy, and persistence of long–term mirabegron for overactive bladder (OAB). The data indicated that long–term OAB treatment with mirabegron was well–tolerated, with effectiveness maintained through 1 year. In addition, mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years.

Methods

• In this study, patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years.
• They collected data on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations.
• They estimated treatment persistence rates by Kaplan–Meier analysis.

Results

• They found 81 ADR in 72/1139 patients (6.3%) through 1 year of mirabegron treatment, with the incidence highest during the first month.
• There were no significant change in residual urine volume at any observation point up to 1 year of mirabegron treatment.
• It was showed that Mirabegron was deemed “effective” in 883/1091 patients (80.9%) at 1 year/discontinuation.
• The evidence suggested that total OABSS was decreased with statistical significance at 3 months, 6 months, and 1 year, or at discontinuation (P < 0.001 at each time point).
• Kaplan–Meier treatment persistence rates were 84.8%,77.6%, , 66.0% at at 3 months, 6 months and 1 year respectively.
• They found similar treatment persistence rates 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).