Empagliflozin Not Linked to Increased Risk of Urinary Tract Cancers: Study
Empagliflozin use in patients with type 2 diabetes (T2D) has not been shown to have a higher risk of urinary tract cancers (UTCs), such as bladder and renal cancers, compared to dipeptidyl peptidase-4 inhibitors (DPP-4i), according to researchers. The research provides reassurance about the cancer safety profile of empagliflozin, a widely prescribed sodium-glucose co-transporter 2 (SGLT2) inhibitor for the treatment of T2D. The study was published in Diabetes Obesity & Metabolism by Niklas S. and colleagues.
The research was a non-interventional, retrospective cohort study among adult patients with T2D who were new users of empagliflozin or DPP-4 inhibitors. The data covered the period between 2014 and 2020 in Sweden and Finland, and up to 2021 in the UK. A total of 151,055 propensity score-matched patients were contributed from the three nations. The analysis used an "as-treated" strategy and adopted a latency of 180 days after the first prescription to minimize confounding by the premature development of cancer.
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
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