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SGLT2 Inhibitors and Bladder Cancer: Analysis of Cases Reported in the European Pharmacovigilance Database

Montserrat García1, Unai Arteche-Martinez2, Unax Lertxundi3

  • 1Biocruces Bizkaia Health Research Institute, Osakidetza Basque Health Service, Galdakao-Usansolo Hospital, Basque Country Pharmacovigilance Unit, Galdakao, Spain.

Journal of Clinical Pharmacology
|August 23, 2020
PubMed

Insights

Sodium-glucose cotransporter 2 inhibitors (SGLT2is) showed a higher reported bladder cancer risk in EudraVigilance. However, this association diminished when compared to other antidiabetics, suggesting potential confounding factors.

Area of Science:

  • Pharmacovigilance
  • Oncology
  • Endocrinology

Background:

  • The cancer risk associated with sodium-glucose cotransporter 2 inhibitors (SGLT2is) remains uncertain.
  • EudraVigilance data is analyzed to investigate potential links between SGLT2is and bladder cancer.
  • Previous studies have not definitively established a causal relationship.

Purpose of the Study:

  • To assess the disproportionality of bladder cancer case reports associated with SGLT2is in the EudraVigilance database.
  • To quantify the association between SGLT2is and bladder cancer using reporting odds ratios (RORs).
  • To explore potential confounding factors and biases, such as indication and notoriety, in the observed association.

Main Methods:

  • A case/noncase study design was employed using EudraVigilance data from November 2012 to May 2020.
  • Reporting odds ratios (RORs) were calculated for pooled SGLT2is and individual agents, comparing them against all other drugs and then against other antidiabetics.
  • Sensitivity analyses, including excluding pioglitazone and analyzing RORs over time, were performed to evaluate potential biases.

Main Results:

  • A total of 6602 bladder cancer cases were identified among 4,213,637 reports; 155 involved SGLT2is.
  • Pooled SGLT2is showed a significantly higher ROR for bladder cancer (3.97; 95% CI, 3.39-4.66), with dapagliflozin showing the strongest association (ROR, 7.02; 95% CI, 5.69-8.66).
  • This disproportionality diminished when comparing SGLT2is with other antidiabetics (ROR, 0.20; 95% CI, 0.17-0.24), but re-emerged after excluding pioglitazone (ROR, 6.84; 95% CI, 5.41-8.65).

Conclusions:

  • The study identified a disproportionately high number of bladder cancer reports associated with SGLT2is in EudraVigilance.
  • The observed association may be influenced by confounding by indication or notoriety bias, as it weakened when compared to other antidiabetics.
  • Further observational analytical studies are necessary to confirm these findings and elucidate the true relationship between SGLT2is and bladder cancer risk.
Keywords:
EudraVigilanceSGLT2 inhibitorsbladder cancerdrug safety surveillancespontaneous reporting system

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