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

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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 of UTC (adjusted HR = 0.88, 95% confidence intervals [CIs]: 0.66-1.17), bladder cancer (adjusted HR = 0.91, 95% CI: 0.63-1.33) or renal cancer (adjusted HR = 0.89, 95% CI: 0.57-1.38) for empagliflozin initiators compared with DPP-4i initiators. 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.