Quality of life in patients aged 65 years and older with overactive bladder treated with mirabegron across eight European countries: Secondary analysis of BELIEVE

Abstract

To describe quality of life outcomes in patients with overactive bladder aged ≥65years receiving mirabegron, a β3-adrenoreceptor agonist (BELIEVE). BELIEVE was a European, prospective, non-interventional, real-world study of 848 patients with overactive bladder prescribed mirabegron in clinical practice. Overactive bladder questionnaire subscales were prespecified primary end-points, analyzed in the full analysis set (patients completing the questionnaire at baseline and ≥1 follow-up visit) and per protocol set (patients still taking mirabegron at 10-12months) using accepted standards for minimally important differences (10points). Nearly half of the patients in the full analysis set (380/796 [47.7%]) and per protocol set (224/452 [49.6%]) were aged ≥65years. Similar proportions of patients aged ≥65years (224/407; 55.0%) and <65years (228/441; 51.7%) were taking mirabegron at 10-12months. Mean symptom bother scores improved from baseline to month10-12 in older patients (full analysis set 52.4to 32.9; per protocol set 51.6to 30.4) and younger patients (full analysis set 52.2to 27.4; per protocol set 47.8to 23.7). Proportions of older/younger patients with improvement in symptom bother were similar (full analysis set 52.1%/52.9%; per protocol set 70.1%/72.4%, respectively). Mean total quality of life scores improved in older patients (full analysis set 60.7-75.9; per protocol set 61.1-77.5) and younger patients (full analysis set 54.9to 77.6; per protocol set 56.8to 80.1). No unexpected safety issues were observed. Patients aged ≥65years receiving mirabegron in clinical practice reported clinically meaningful improvements in quality of life.