Using real world data to assess cardiovascular outcomes of two antidiabetic treatment classes
Using real world data to assess cardiovascular outcomes of two antidiabetic treatment classes
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DOI：
10.4239/wjd.v9.i12.252
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发表时间：
2018-12-15
影响因子：
4.2
通讯作者：
Stapff, Manfred Paul
中科院分区：
文献类型：
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作者：
Stapff, Manfred Paul
目的通过分析电子病历来评估钠-葡萄糖协同转运蛋白 2 (SGLT2) 抑制剂在现实世界中对心血管结局的影响。方法我们使用 TriNetX，这是一个提供电子健康记录 (EHR) 统计数据的全球联合研究网络。分析子集包含来自美国 35 个医疗保健组织的约 3800 万患者的 EHR。将 46,909 名服用 SGLT2 抑制剂的患者的记录与 189,120 名服用二肽基肽酶 (DPP) 4 抑制剂的患者的记录进行比较。我们确定了五个潜在的混杂因素并建立了各自的分层：老年人、高血压、慢性肾病（CKD）以及胰岛素或二甲双胍联合用药。心血管事件被计为患者记录中首次使用相应药物后三年内发生的中风（ICD10代码：I63）或心肌梗死（ICD10：I21）。 结果在EHR中使用SGLT2抑制剂的46909名患者中，1667名患者（3.6%）在首次用药后的前三年内有中风或心肌梗死的ICD代码。在对照组中，189120 名患者发生了 10680 起事件（5.6%），风险比为 0.63（95% CI：0.60-0.66）。在具有潜在混杂危险因素的阶层中，中风或心肌梗死的总体发生率从服用二甲双胍的患者的 4.9% 上升到最高风险阶层（合并 CKD）的 12.5%。在所有阶层中，发生心血管事件的风险差异同样有利于 SGLT2 与对照，风险比范围为 0.62 至 0.81。 结论真实世界数据复制了随机临床试验的结果，证实了 SGLT2 抑制剂的心血管优势，并显示了其对美国人群的适用性。
AIMTo evaluate the effect on cardiovascular outcomes of sodium-glucose co-transporter-2 (SGLT2) inhibitors in a real world setting by analyzing electronic medical records.METHODSWe used TriNetX, a global federated research network providing statistics on electronic health records (EHR). The analytics subset contained EHR from approximately 38 Million patients in 35 Health Care Organizations in the United States. The records of 46,909 patients who had taken SGLT2 inhibitors were compared to 189,120 patients with dipeptidyl peptidase (DPP) 4 inhibitors. We identified five potential confounding factors and built respective strata: elderly, hypertension, chronic kidney disease (CKD), and co-medication with either insulin or metformin. Cardiovascular events were counted as stroke (ICD10 code: I63) or myocardial infarction (ICD10: I21) occurring within three years after the first instance of the respective medication in the patients' records.RESULTSOf the 46909 patients with SGLT2 inhibitors in their EHR, 1667 patients (3.6%) had an ICD code for stroke or for myocardial infarction within the first three years after the first instance of the medication. In the control group, there were 10680 events of 189120 patients (5.6%), which represents a risk ratio of 0.63 (95% CI: 0.60-0.66). The overall incidence of stroke or myocardial infarction in the strata with a potential confounding risk factor reached from 4.9% in patients taking metformin to 12.5% in the stratum with the highest risk (concomitant CKD). In all strata, the difference in risk of experiencing a cardiovascular event was similarly in favor of SGLT2 vs control, with Risk Ratio ranging from 0.62 to 0.81.CONCLUSIONReal world data replicated the results from randomized clinical trials, confirmed the cardiovascular advantages of SGLT2 inhibitors, and showed its applicability to the US population.