Empagliflozin Not Linked to Increased Risk of Urinary Tract Cancers: Study

The researchers calculated incidence rates (IRs) and hazard ratios (HRs) for UTCs by using Cox regression models that were controlled for age, sex, comorbidities, and other potential confounders. Random-effects meta-analysis was employed to combine results by country.

Results

• The matched cohort consisted of 151,055 patients with T2D, the majority being female (between 59.6% and 67.8%), and the mean empagliflozin user's age ranged between 57.0 and 63.2 years across countries.

The meta-analysis demonstrated:

• There was no significant increase in total UTC risk among individuals using empagliflozin when compared to those using DPP-4i (adjusted HR = 0.88; 95% CI: 0.66–1.17).

• Risk of bladder cancer was likewise unaffected (adjusted HR = 0.91; 95% CI: 0.63–1.33).

• Risk for renal cancer was also not increased (adjusted HR = 0.89; 95% CI: 0.57–1.38).

In this multinational, large-scale cohort study, empagliflozin was not linked with a higher risk of urinary tract, bladder, or kidney cancers compared with DPP-4 inhibitors in adults with type 2 diabetes. The findings indicate the long-term safety of empagliflozin in terms of cancer risk and support its position in holistic diabetes management.

Reference:

Schmedt, N., Alhamdow, A., Tskhvarashvili, G., Saarelainen, L., Qiao, X., Lobier, M., & Hoti, F. (2025). Post-authorisation safety study to assess the risk of urinary tract cancer in people with type 2 diabetes initiating empagliflozin: A multi-country European study. Diabetes, Obesity & Metabolism. https://doi.org/10.1111/dom.16477