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Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO

Paul Gautier1,2,3, Meyer Elbaz3, Frédéric Bouisset3

  • 1Department of Medical and Clinical Pharmacology, Faculty of Medicine, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), 37 Allées Jules Guesde, 31000, Toulouse, France.

Drug Safety
|April 15, 2025
PubMed
Abstract

Insights

Sodium-glucose cotransporter 2 inhibitors (SGLT-2is) may increase the risk of bladder and kidney cancers. Further studies are needed to confirm these findings and clarify the association between SGLT-2is and cancer risk.

Area of Science:

  • Pharmacovigilance
  • Oncology
  • Endocrinology

Background:

  • Sodium-glucose cotransporter 2 inhibitors (SGLT-2is) are increasingly used for their cardiovascular benefits.
  • Concerns exist regarding a potential increased cancer risk with SGLT-2is, but previous studies had methodological limitations.

Purpose of the Study:

  • To investigate the association between SGLT-2 inhibitor use and the risk of various cancer subtypes.
  • To compare cancer reporting risks between SGLT-2is and other diabetes medications like GLP-1 analogues and DPP-4 inhibitors.

Main Methods:

  • A disproportionality analysis was conducted using Vigibase® data from 2014 to 2023.
  • The study compared cancer reporting rates associated with SGLT-2is against those of GLP-1 analogues and DPP-4 inhibitors.

Main Results:

  • An increased reporting odds ratio for bladder cancer (ROR 4.46) and kidney cancer (ROR 1.84) was observed with SGLT-2i use.
  • No significant association was found for other cancer subtypes.
  • The analysis included 644 reported cancer cases linked to SGLT-2i use, with a mean patient age of 66.5 years.

Conclusions:

  • SGLT-2 inhibitors are associated with an increased risk of reporting bladder and kidney cancers.
  • This hypothesis-generating signal requires urgent clarification through further long-term observational studies.

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