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Peer-reviewedCC BY 4.0Cancers

Comparative Neoplasm Risk of Mirabegron and Antimuscarinic Therapy in Overactive Bladder: A Multicenter Target Trial Emulation

  • Fu-Shun Yen1
  • James Cheng-Chung Wei2,3,4
  • Chih-Cheng Hsu5,6,7,8
  • Chii-Min Hwu9,10
  • Yao-Min Hung11,12,13
  • Renin Chang11,14,15
  • Tzu-Ping Lin16,17
17 affiliations
  1. 1Dr. Yen’s Clinic, No. 15, Shanying Road, Gueishan District, Taoyuan 33354, Taiwan
  2. 2Institute of Medicine, Chung Shan Medical University, Taichung 40201, Taiwan
  3. 3Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, No. 110, Sec. 1, Jianguo N. Rd., South District, Taichung 40201, Taiwan
  4. 4Graduate Institute of Integrated Medicine, China Medical University, No. 91, Hsueh-Shih Road, Taichung 40402, Taiwan
  5. 5Institute of Population Health Sciences, National Health Research Institutes, 35 Keyan Road, Zhunan, Miaoli County 35053, Taiwan
  6. 6Department of Health Services Administration, China Medical University, No. 91, Hsueh-Shih Road, Taichung 40402, Taiwan
  7. 7Department of Family Medicine, Min-Sheng General Hospital, 168 ChingKuo Road, Taoyuan 33044, Taiwan
  8. 8National Center for Geriatrics and Welfare Research, National Health Research Institutes, No. 95-1, Xuefu Rd., Huwei Township, Yunlin County 632007, Taiwan
  9. 9Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Road, Beitou District, Taipei 11217, Taiwan
  10. 10Faculty of Medicine, National Yang Ming Chiao Tung University School of Medicine, Taipei 11221, Taiwan
  11. 11Department of Medical Education and Research, Kaohsiung Veterans General Hospital, Kaohsiung 81346, Taiwan
  12. 12Department of Internal Medicine, Taitung Hospital, Ministry of Health and Welfare, Taitung 95043, Taiwan
  13. 13Master Program in Biomedicine, College of Science and Engineering, National Taitung University, Taitung 95092, Taiwan
  14. 14Department of Emergency Medicine, Kaohsiung Veterans General Hospital, Kaohsiung 81346, Taiwan
  15. 15Department of Recreation and Sports Management, Tajen University, Pintung 90741, Taiwan
  16. 16Department of Urology, College of Medicine and Shu-Tien Urological Research Center, National Yang Ming Chiao Tung University, Taipei 11221, Taiwan
  17. 17Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung 81346, Taiwan
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Abstract

Background/Aims: Mirabegron, a selective β3-adrenergic receptor agonist used to treat overactive bladder (OAB), can promote adipose tissue browning and alter systemic metabolism, raising interest in its potential relationship with cancer development. However, clinical evidence regarding cancer risk remains limited and inconsistent. We compared the risks of obesity-related and site-specific cancers between patients with OAB initiating mirabegron and those initiating antimuscarinic medications. Methods: We conducted a multicenter emulated target trial using the TriNetX Global Collaborative Network. Adults aged ≥20 years with OAB or related symptoms who newly initiated mirabegron or an antimuscarinic medication were included using a new-user, active-comparator design. Patients with pre-existing malignancy were excluded. Propensity score matching was performed 1:1, and a 1-year lag period after treatment initiation was applied for cancer outcomes to reduce potential reverse causation from occult malignancy. Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs) under an intention-to-treat analog. Results: A 365-day lag/landmark period was applied before propensity-score matching. Patients with a recorded neoplasm or death during this period, or without follow-up extending through day 366, were excluded. Subsequent 1:1 propensity-score matching yielded 106,500 patients in each treatment group. Mirabegron initiation was not associated with the composite of obesity-related neoplasms compared with antimuscarinic initiation (HR, 1.011; 95% CI, 0.954–1.071). The individual neoplasm outcomes also showed no significant between-group differences. However, among patients eligible for the 1-year landmark mortality analysis, mirabegron initiation was associated with higher subsequent all-cause mortality (HR, 1.083; 95% CI, 1.044–1.124). Exploratory negative-control analysis of Hodgkin lymphoma showed no significant association. Conclusions: Among patients with OAB, mirabegron initiation was not associated with a significant difference in overall obesity-related neoplasm risk compared with antimuscarinic initiation. The observed associations with all-cause mortality should be interpreted cautiously given the observational design, multiple comparisons, and potential residual confounding. These findings are hypothesis-generating and require confirmation in prospective studies.

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Cite

BibTeXRIS
BibTeX
@article{yen2026comparative,
  title = {{Comparative Neoplasm Risk of Mirabegron and Antimuscarinic Therapy in Overactive Bladder: A Multicenter Target Trial Emulation}},
  author = {Fu-Shun Yen and James Cheng-Chung Wei and Chih-Cheng Hsu and Chii-Min Hwu and Yao-Min Hung and Renin Chang and Tzu-Ping Lin},
  journal = {Cancers},
  year = {2026},
  month = oct,
  doi = {10.3390/cancers18203279},
  url = {https://www.mdpi.com/2072-6694/18/20/3279},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Comparative Neoplasm Risk of Mirabegron and Antimuscarinic Therapy in Overactive Bladder: A Multicenter Target Trial Emulation
AU  - Fu-Shun Yen
AU  - James Cheng-Chung Wei
AU  - Chih-Cheng Hsu
AU  - Chii-Min Hwu
AU  - Yao-Min Hung
AU  - Renin Chang
AU  - Tzu-Ping Lin
PY  - 2026
DA  - 2026/10/01
JO  - Cancers
DO  - 10.3390/cancers18203279
UR  - https://www.mdpi.com/2072-6694/18/20/3279
AB  - Background/Aims: Mirabegron, a selective β3-adrenergic receptor agonist used to treat overactive bladder (OAB), can promote adipose tissue browning and alter systemic metabolism, raising interest in its potential relationship with cancer development. However, clinical evidence regarding cancer risk remains limited and inconsistent. We compared the risks of obesity-related and site-specific cancers between patients with OAB initiating mirabegron and those initiating antimuscarinic medications. Methods: We conducted a multicenter emulated target trial using the TriNetX Global Collaborative Network. Adults aged ≥20 years with OAB or related symptoms who newly initiated mirabegron or an antimuscarinic medication were included using a new-user, active-comparator design. Patients with pre-existing malignancy were excluded. Propensity score matching was performed 1:1, and a 1-year lag period after treatment initiation was applied for cancer outcomes to reduce potential reverse causation from occult malignancy. Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs) under an intention-to-treat analog. Results: A 365-day lag/landmark period was applied before propensity-score matching. Patients with a recorded neoplasm or death during this period, or without follow-up extending through day 366, were excluded. Subsequent 1:1 propensity-score matching yielded 106,500 patients in each treatment group. Mirabegron initiation was not associated with the composite of obesity-related neoplasms compared with antimuscarinic initiation (HR, 1.011; 95% CI, 0.954–1.071). The individual neoplasm outcomes also showed no significant between-group differences. However, among patients eligible for the 1-year landmark mortality analysis, mirabegron initiation was associated with higher subsequent all-cause mortality (HR, 1.083; 95% CI, 1.044–1.124). Exploratory negative-control analysis of Hodgkin lymphoma showed no significant association. Conclusions: Among patients with OAB, mirabegron initiation was not associated with a significant difference in overall obesity-related neoplasm risk compared with antimuscarinic initiation. The observed associations with all-cause mortality should be interpreted cautiously given the observational design, multiple comparisons, and potential residual confounding. These findings are hypothesis-generating and require confirmation in prospective studies.
SN  - 2072-6694
ER  -