Aims
This study aimed to assess the risk of urinary tract cancers (UTCs), including bladder and renal cancers, in people with type 2 diabetes (T2D) initiating empagliflozin compared with people initiating any dipeptidyl peptidase-4 inhibitor (DPP-4i) in the United Kingdom (UK), Sweden, and Finland.
Materials and Methods
This was a non-interventional, multi-country cohort study based on secondary data in Sweden, Finland, and the UK. The study used an active comparator, new user design and included propensity score-matched adults with T2D initiating empagliflozin or a DPP-4i between 2014 and 2020 (2021 for the UK).
Follow-up started at the index date (first prescription or dispensation for empagliflozin or a DPP-4i) and 180 days were considered as the latency period. Incidence rates (IRs) and hazard ratios (HRs) were estimated under an as-treated approach in each country. HRs were then entered into a random-effects meta-analysis.
Results
The main analyses included 151,055 matched people. The mean age for empagliflozin initiators was 57.0–63.2 years across the countries, and most were female (59.6%–67.8%).
A meta-analysis of country-level HR showed no evidence of an increased risk for empagliflozin initiators compared with DPP-4i initiators:
- urinary tract cancer (UTC): adjusted HR 0.88, 95% confidence interval [CI]: 0.66–1.17
- bladder cancer: adjusted HR 0.91, 95% CI: 0.63–1.33
- renal cancer: adjusted HR 0.89, 95% CI: 0.57–1.38
Various sensitivity analyses also validated the robustness of the main findings.
Conclusions
No increased risk of UTC, bladder, and renal cancer was observed when empagliflozin initiators were compared with DPP-4i initiators in this non-interventional cohort study.
Keywords: CPRD; DPP-4 inhibitor; SGLT2i; bladder cancer; diabetes type 2; epidemiology; meta-analysis; nordic countries; renal cancer; urinary tract cancer.
© 2025 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
