Blood pressure increases and other safety and medication compliance in overactive bladder patients treated with Selebeta ® PR tablets: A noninterventional, multicenter, retrospective observational study

Purpose: This study aimed to evaluate the safety, including blood pressure changes, and medication compliance associated with a generic prolonged-release formulation of mirabegron (Selebeta PR Tab.50 mg) in Korean adults with overactive bladder (OAB) through a large-scale, real-world, multicenter, retrospective observational study.Materials and Methods: Patients with OAB who were prescribed Selebeta PR once daily for at least 3 months between July 2020 and July 2021 from 95 medical institutions in Korea were included.The primary endpoint was the proportion of patients with an increase in systolic blood pressure (SBP) of 10 mmHg after 3 months of treatment.Secondary endpoints included additional thresholds of blood pressure elevation, changes in SBP and diastolic blood pressure (DBP) and pulse rate over time, improvement in OAB symptom, incidence of adverse events, and medication compliance.Results: A total of 2,091 patients were enrolled in the study.After 3 months of treatment, 8.8% of the patients had an SBP increase of 10 mmHg; 3.7%, 15 mmHg; and 2.3%, 20 mmHg.DBP increased by 5 mmHg in 16.8% and by 10 mmHg in 6.7% of patients.OAB symptoms also improved significantly in the subgroup with available OAB symptom score data.The overall incidence of adverse events was 2.1%, mostly mild, and mean medication coverage was 73.6%.Conclusions: This study demonstrated that Selebeta PR is an effective and well-tolerated treatment for adults with OAB, with no clinically meaningful increase in blood pressure and a low incidence of adverse events.