Safety and effectiveness of mirabegron in patients with overactive bladder aged ≥75 years: Analysis of a Japanese post-marketing study

Abstract

Objectives: A 12-week post-marketing study was conducted to provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with mirabegron. This post-hoc analysis focused on safety and effectiveness of mirabegron in patients aged ≥75 versus <75 years. Methods: Incidence of adverse drug reactions (ADR) was assessed following 12 weeks’ mirabegron treatment. Overactive Bladder Symptom Score (OABSS) and International-Prostate Symptom Score Quality of Life (I-PSS QoL) were completed at baseline and at the end of treatment (EoT). A reduction of ≥3 points in total OABSS was defined as a minimal clinically important change (MCIC). Results: Of 9795 patients, a greater proportion aged ≥75 versus <75 years had a lower body mass index (BMI; BMI < 18.5: 4.2% vs 3.2%), longer OAB duration (≥3 years: 24.6% vs 20.3%) and more severe OAB symptoms (severe: 17.0% vs 11.2%). A significantly greater percentage of patients aged ≥75 versus <75 years had comorbidities (77.8% vs 66.0%) and used concomitant drugs (58.3% vs 48.7%; P < 0.001). Incidence of ADR was observed in 7.00% and 5.19% of patients aged ≥75 versus <75 years, respectively. At EoT, mirabegron treatment was reported ‘effective’ in 79.3% versus 82.1% of patients aged ≥75 versus <75 years, respectively. Mean total OABSS decreased significantly from baseline, and exceeded the MCIC in 61.0% and 65.9% of patients aged ≥75 and <75 years, respectively. Similar changes were observed for I-PSS QoL in both groups. Conclusions: In a real-world clinical setting, mirabegron was well-tolerated and effective in patients aged ≥75 and <75 years.