Overactive bladder (OAB) is a chronic syndrome and therefore it is vital to demonstrate the safety and effectiveness of long-term pharmacotherapy approaches for treating this condition. As such, this surveillance study explored the 3-year safety, efficacy, and persistence of mirabegron therapy for treating patients with OAB symptoms in the real-world setting.

This was a 3-year study that included patients who had started mirabegron therapy for the treatment of OAB symptoms. Electronic records were used to capture the study data. Safety evaluations included adverse drug reaction (ADR) and residual urine volume assessments. OAB symptom and Overactive Bladder Symptom Score (OABSS) evaluations were used to investigate efficacy and persistence was estimated using the Kaplan-Meier method. This study was conducted in accordance with the Good Post-marketing Study Practice standards of the Ministry of Health, Labour, and Welfare in Japan.

In total, 1138 patients were included in the study. The mean age of the patients was 71.9 ± 10.95 years and 574 (50.4%) were women. Overall, 109 ADRs were reported by 97 (8.52%) patients (Table) with a decreasing incidence over time (<1 year: 1.34%–2.37%, ≥1–<2 years: 0.45%–1.60%, ≥2–<3 years: 0.29%–1.10%; 3-monthly interval data). No significant increases in residual urine volume were observed. Following investigator assessment, mirabegron was considered to be an effective treatment for 842/1082 (77.8%) patients. Throughout the study, significant decreases in OABSS were apparent (p<0.001) and 321 (65.1%) out of the 493 patients in the OABSS analysis set achieved a minimal clinically important change (MCIC) in OABSS. Those who achieved an MCIC within ≤1 year typically continued to maintain an MCIC throughout the rest of the study (>1–≤2 years: 117 [88.0%] patients, >2 years: 80 [89.9%] patients). After 1, 2, and 3 years, treatment persistence rates of 65.8%, 52.9%, and 46.7% were respectively noted with mirabegron.

The results of this long-term study indicate that mirabegron was well tolerated and no cumulative events or delayed ADRs were observed. The majority of patients who positively responded to mirabegron in the first year continued to respond over the 3-year study period. Long-term persistence with mirabegron treatment was also observed in this routine clinical setting. In combination, these results show that mirabegron could be used as an effective long-term therapy in clinical practice for treating patients with OAB symptoms.

The safety, efficacy, and persistence of 3-year treatment with mirabegron in patients with OAB symptoms were demonstrated in this clinical practice study.