Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladder
"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-inter...
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| Format: | Article |
| Language: | English |
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Korean Urological Association
2025-01-01
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| Series: | Investigative and Clinical Urology |
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| Online Access: | https://www.icurology.org/pdf/10.4111/icu.20240278 |
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| _version_ | 1841553354304520192 |
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| author | Jee Soo Park Won Sik Jang Jongchan Kim Moon-Hwa Park Won Sik Ham |
| author_facet | Jee Soo Park Won Sik Jang Jongchan Kim Moon-Hwa Park Won Sik Ham |
| author_sort | Jee Soo Park |
| collection | DOAJ |
| description | "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."
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| format | Article |
| id | doaj-art-0fbbf0387d1f45bebc788ec792adbd31 |
| institution | Kabale University |
| issn | 2466-0493 2466-054X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Korean Urological Association |
| record_format | Article |
| series | Investigative and Clinical Urology |
| spelling | doaj-art-0fbbf0387d1f45bebc788ec792adbd312025-01-09T09:10:04ZengKorean Urological AssociationInvestigative and Clinical Urology2466-04932466-054X2025-01-01661273510.4111/icu.20240278Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladderJee Soo Park0https://orcid.org/0000-0001-9976-6599 Won Sik Jang1https://orcid.org/0000-0002-9082-0381Jongchan Kim2https://orcid.org/0000-0002-0022-6689 Moon-Hwa Park3https://orcid.org/0009-0006-5281-7348Won Sik Ham4https://orcid.org/0000-0003-2246-8838Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.Hanmi Pharmaceutical Co., Ltd., Seoul, Korea.Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea."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." https://www.icurology.org/pdf/10.4111/icu.20240278adrenergic beta-3 receptor agonistsmirabegronurinary bladderoveractive |
| spellingShingle | Jee Soo Park Won Sik Jang Jongchan Kim Moon-Hwa Park Won Sik Ham Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladder Investigative and Clinical Urology adrenergic beta-3 receptor agonists mirabegron urinary bladder overactive |
| title | Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladder |
| title_full | Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladder |
| title_fullStr | Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladder |
| title_full_unstemmed | Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladder |
| title_short | Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladder |
| title_sort | multi center prospective non interventional observational study on the efficacy and safety of mirabek r in adult patients with overactive bladder |
| topic | adrenergic beta-3 receptor agonists mirabegron urinary bladder overactive |
| url | https://www.icurology.org/pdf/10.4111/icu.20240278 |
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