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Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase®

Author

Listed:
  • Paul Gautier

    (Toulouse University Hospital (CHU)
    Toulouse University Hospital
    University Hospital of Toulouse)

  • Meyer Elbaz

    (University Hospital of Toulouse)

  • Frédéric Bouisset

    (University Hospital of Toulouse)

  • Fabien Despas

    (Toulouse University Hospital (CHU)
    Toulouse University Hospital)

  • François Montastruc

    (Toulouse University Hospital (CHU)
    Toulouse University Hospital)

Abstract

Introduction Use of sodium-glucose cotransporter 2 inhibitors (SGLT-2is) has significantly increased due to their cardiovascular benefits. Whether SGLT-2is increase risk of cancer has been of concern since first clinical trials, but this question remains unclear because of methodological limitations in previous studies. Methods We conducted a disproportionality analysis using Vigibase® between 2014 and 2023 to estimate the association between SGLT-2i use and the risk of reporting of different subtypes of cancers, compared with glucagon like peptide-1 (GLP-1) analogues and dipeptidyl peptidase-4 (DPP-4) inhibitors. Results Among 644 reported cases of cancer associated with SGLT-2i use, 427 (66.3%) were male, with a mean age of 66.5 ± 9.7 years. Sodium-glucose cotransporter 2 inhibitors showed increased reporting odds ratio for bladder cancer (ROR 4.46, 95% CI 3.23–6.17) and kidney cancer (ROR 1.84, 95% CI 1.25–2.69), but not for all other cancer subtypes. Conclusion In this disproportionality analysis with a hypothesis-generating approach, SGLT-2is are associated with an increased risk of reporting bladder and kidney cancer. There is a need of an urgent clarification of this signal with further long-term observational studies. Graphical Abstract Graphical abstract of the study design and results. CI confidence interval, DPP-4i dipeptidyl peptidase 4 inhibitors, GLP-1a glucagon-like peptide 1 agonists, ROR reporting odds ratio, SGLT-2is sodium-glucose cotransporter 2 inhibitors

Suggested Citation

  • Paul Gautier & Meyer Elbaz & Frédéric Bouisset & Fabien Despas & François Montastruc, 2025. "Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase®," Drug Safety, Springer, vol. 48(8), pages 933-941, August.
    • Handle: RePEc:spr:drugsa:v:48:y:2025:i:8:d:10.1007_s40264-025-01546-5
    DOI: 10.1007/s40264-025-01546-5
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