Investig Clin Urol.  2025 Jan;66(1):27-35. 10.4111/icu.20240278.

Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek^® in adult patients with overactive bladder

• Park JS
• Jang WS
• Kim J
• Park MH
• Ham WS

• KMID: 2563753
• DOI: http://doi.org/10.4111/icu.20240278

Abstract

Purpose
Mirabegron, the first-in-class beta-3 agonist, is the mainstay medication for overactive bladder (OAB). The aim of this study was to investigate the efficacy and safety of generic drugs of mirabegron (Mirabek^® ) in adults diagnosed with OAB through a multicenter, prospective, non-interventional observational study.
Materials and Methods
Adult patients with OAB prescribed Mirabek^® SR Tab. 50 mg for the first time were recruited from hospitals between September 2021 and September 2022. Participants underwent baseline registration followed by two follow-ups at 4-and 8-week intervals. Data on demographics, medical history, OAB symptoms, vital signs, medication administration, and adverse events were collected.
Results
Among 1,714 patients, Mirabek^® SR Tab. 50 mg effectively improved OAB symptoms over an 8-week treatment period, with significant differences in symptom improvement between baseline and both 4- and 8-week time points as well as between 4 weeks and 8 weeks. The incidence rate of adverse events was 0.70%; most cases were mild with no severe reactions.
Conclusions
This study demonstrated that Mirabek^® , a generic drug of betmiga, is an effective and safe treatment option for adults with OAB. Furthermore, the introduction of generic drug reduced the costs of prescription drugs and expanded the opportunity for many patients to access mirabegron.

Keyword

Adrenergic beta-3 receptor agonists; Mirabegron; Urinary bladder, overactive