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

Paul Gautier, Meyer Elbaz, Frédéric Bouisset, Fabien Despas and François Montastruc ()
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Paul Gautier: Toulouse University Hospital (CHU)
Meyer Elbaz: University Hospital of Toulouse
Frédéric Bouisset: University Hospital of Toulouse
Fabien Despas: Toulouse University Hospital (CHU)
François Montastruc: Toulouse University Hospital (CHU)

Drug Safety, 2025, vol. 48, issue 8, No 7, 933-941

Abstract: 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

Date: 2025
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DOI: 10.1007/s40264-025-01546-5

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