Effectiveness and Safety of Mirabek Sustained-release 50 mg Tablets in Korean Patients with Overactive Bladder: A Multicenter Observational Study at Tertiary General Hospitals

Abstract

Background and objective: Mirabegron, a first-in-class b3-adrenergic agonist, is a key therapy for overactive bladder (OAB). This study aimed to evaluate the real-world effectiveness and safety of generic mirabegron (Mirabek) in Korean patients with OAB through a multicenter, prospective, noninterventional observational study at tertiary general hospitals. Methods: Adult patients with OAB newly prescribed Mirabek sustained-release 50 mg tablets were enrolled from 46 tertiary general hospitals. Assessments were performed at baseline and follow-up visits at 3 and 6 mo. Data collected included the OAB Symptom Score (OABSS), bladder diaries, uroflowmetry results, and adverse events. Key findings and limitations: Among the 4009 participants analyzed, 81.3% completed 6 mo of treatment. At 3 and 6 mo, 35.3% and 43.4% of participants, respectively, achieved a >= 3-point reduction in total OABSS (p < 0.0001), with the mean score improving from 6.9 to 4.6. All seven bladder diary parameters, including urgency and incontinence, showed significant improvement. Treatment satisfaction increased, and 67.3% of participants continued Mirabek at 6 mo. Adverse events occurred in 5.5% of participants, with 1.8% being drug related; all were mild. Conclusions and clinical implications: Mirabek (generic mirabegron) demonstrated effective symptom relief and was well tolerated in Korean patients with OAB, with sustained efficacy up to 6 mo. The introduction of Mirabek substantially reduced treatment costs and expanded access to mirabegron therapy. Patient summary: In this study, we looked at the effect of Mirabek, a generic medication for overactive bladder (OAB), in >4000 Korean patients treated in large hospitals. We found that Mirabek improved bladder symptoms such as urgency and frequent urination over 6 mo, with very few side effects. Most patients stayed on the treatment and reported feeling better, suggesting that this affordable medication can help more people manage their OAB effectively. (c) 2025 The Author(s). Urology. This is an op Published by Elsevier B.V. on behalf of European Association of en access article under the CC BY-NC-ND license (http://creative-commons.org/licenses/by-nc-nd/4.0/).