Schmedt Niklas, Alhamdow Ayman, Tskhvarashvili Giorgi, Saarelainen Laura, Qiao Xu, Lobier Muriel, Hoti Fabian
Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
IQVIA, Tallinn, Estonia.
Diabetes Obes Metab. 2025 Aug;27(8):4401-4414. doi: 10.1111/dom.16477. Epub 2025 Jun 13.
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.
目的:本研究旨在评估在英国、瑞典和芬兰,与开始使用任何二肽基肽酶-4抑制剂(DPP-4i)的2型糖尿病(T2D)患者相比,开始使用恩格列净的T2D患者发生泌尿系统癌症(UTC)(包括膀胱癌和肾癌)的风险。 材料与方法:这是一项基于瑞典、芬兰和英国的二手数据的非干预性多国队列研究。该研究采用活性对照、新使用者设计,纳入了2014年至2020年(英国为2021年)开始使用恩格列净或DPP-4i的倾向评分匹配的T2D成年患者。随访从索引日期(恩格列净或DPP-4i的首次处方或配药)开始,潜伏期为180天。在每个国家,按照实际治疗方法估计发病率(IR)和风险比(HR)。然后将HR纳入随机效应荟萃分析。 结果:主要分析纳入了151055名匹配患者。各国开始使用恩格列净的患者的平均年龄为57.0 - 63.2岁,大多数为女性(59.6% - 67.8%)。对国家层面HR的荟萃分析显示,与开始使用DPP-4i的患者相比,开始使用恩格列净的患者发生UTC(校正HR = 0.88,95%置信区间[CI]:0.66 - 1.17)、膀胱癌(校正HR = 0.91,95% CI:0.63 - 1.33)或肾癌(校正HR = 0.89,95% CI:0.57 - 1.38)的风险没有增加的证据。各种敏感性分析也验证了主要发现的稳健性。 结论:在这项非干预性队列研究中,与开始使用DPP-4i的患者相比,开始使用恩格列净的患者未观察到UTC、膀胱癌和肾癌风险增加。
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