Stephen Foley1, Nurul Choudhury2, Moses Huang2, Anny Stari2, Jameel Nazir2, Robert Freeman3. 1. Department of Urology, Royal Berkshire Hospital, Reading, Berkshire, UK. 2. Astellas Pharma Europe Ltd, Chertsey, Surrey, UK. 3. Department of Obstetrics and Gynaecology, University Hospitals, Plymouth, Devon, UK.
Abstract
OBJECTIVES: To describe quality of life outcomes in patients with overactive bladder aged ≥65 years receiving mirabegron, a β3-adrenoreceptor agonist (BELIEVE). METHODS: 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 10-12 months) using accepted standards for minimally important differences (10 points). RESULTS: Nearly half of the patients in the full analysis set (380/796 [47.7%]) and per protocol set (224/452 [49.6%]) were aged ≥65 years. Similar proportions of patients aged ≥65 years (224/407; 55.0%) and <65 years (228/441; 51.7%) were taking mirabegron at 10-12 months. Mean symptom bother scores improved from baseline to month 10-12 in older patients (full analysis set 52.4 to 32.9; per protocol set 51.6 to 30.4) and younger patients (full analysis set 52.2 to 27.4; per protocol set 47.8 to 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 54.9 to 77.6; per protocol set 56.8 to 80.1). No unexpected safety issues were observed. CONCLUSIONS: Patients aged ≥65 years receiving mirabegron in clinical practice reported clinically meaningful improvements in quality of life.
OBJECTIVES: To describe quality of life outcomes in patients with overactive bladder aged ≥65 years receiving mirabegron, a β3-adrenoreceptor agonist (BELIEVE). METHODS: 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 10-12 months) using accepted standards for minimally important differences (10 points). RESULTS: Nearly half of the patients in the full analysis set (380/796 [47.7%]) and per protocol set (224/452 [49.6%]) were aged ≥65 years. Similar proportions of patients aged ≥65 years (224/407; 55.0%) and <65 years (228/441; 51.7%) were taking mirabegron at 10-12 months. Mean symptom bother scores improved from baseline to month 10-12 in older patients (full analysis set 52.4 to 32.9; per protocol set 51.6 to 30.4) and younger patients (full analysis set 52.2 to 27.4; per protocol set 47.8 to 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 54.9 to 77.6; per protocol set 56.8 to 80.1). No unexpected safety issues were observed. CONCLUSIONS:Patients aged ≥65 years receiving mirabegron in clinical practice reported clinically meaningful improvements in quality of life.