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在最近的心血管结局试验中评估的降糖治疗的真实世界应用和建模影响:NCDR® 研究到实践项目。

Real-world use and modeled impact of glucose-lowering therapies evaluated in recent cardiovascular outcomes trials: An NCDR® Research to Practice project.

机构信息

1 Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.

2 Yale School of Medicine, New Haven, CT, USA.

出版信息

Eur J Prev Cardiol. 2017 Oct;24(15):1637-1645. doi: 10.1177/2047487317729252. Epub 2017 Sep 5.

Abstract

Aims Recent trials (EMPA-REG OUTCOME and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results [LEADER]) have shown improved cardiovascular (CV) mortality with specific currently available glucose-lowering medications (empagliflozin and liraglutide, respectively), but were limited to selected patient populations. We sought to evaluate the current use and potential real-world impact of empagliflozin (and other sodium-glucose co-transporter 2 inhibitors [SGLT2is]) and liraglutide (and other glucagonlike peptide-1 receptor agonist [GLP-1 RAs]) among patients in the Diabetes Collaborative Registry (DCR). Methods and results We evaluated 182,525 patients from the DCR - a large, US-based outpatient registry of individuals with type 2 diabetes from 313 sites that included cardiology, endocrinology and primary care practices. Among these patients, 26.2% met major eligibility criteria for EMPA-REG OUTCOME and 48.0% met major eligibility criteria for LEADER. Of these potentially eligible patients, only a small minority were actually prescribed these agents: 5.2% on an SGLT2i and 6.0% on a GLP-1 RA, respectively. Patients receiving these studied medications or medication classes, in general, had lower CV disease burden compared with those not on these agents. Assuming similar risk reductions as in the clinical trials, if all potentially trial-eligible patients in the DCR were treated for 1 year with empagliflozin (or other SGLT2is, assuming a class effect) or liraglutide (or other GLP-1 RAs, assuming a class effect), this may have prevented 354 CV deaths, 231 heart failure hospitalizations, 329 CV deaths and 247 myocardial infarctions, respectively. Conclusion In a large, US-based outpatient registry, we found a significant number of patients would have been potentially eligible for glucose-lowering agents that demonstrated CV benefit in recent clinical trials. In view of these findings, a broader and better-targeted use of these medications in evidence-based patient populations should be considered.

摘要

目的

最近的试验(EMPA-REG OUTCOME 和利拉鲁肽对糖尿病的作用和心血管结局评估 [LEADER])表明,特定的现有降血糖药物(恩格列净和利拉鲁肽)可降低心血管死亡率,但仅限于特定的患者人群。我们旨在评估恩格列净(和其他钠-葡萄糖共转运蛋白 2 抑制剂 [SGLT2is])和利拉鲁肽(和其他胰高血糖素样肽-1 受体激动剂 [GLP-1 RAs])在糖尿病协作登记处(DCR)患者中的当前使用情况和潜在的真实世界影响。

方法和结果

我们评估了来自 DCR 的 182,525 名患者,这是一个大型的美国门诊患者登记处,包括来自 313 个地点的 2 型糖尿病患者,这些地点包括心脏病学、内分泌学和初级保健实践。在这些患者中,26.2%符合 EMPA-REG OUTCOME 的主要入选标准,48.0%符合 LEADER 的主要入选标准。在这些潜在合格的患者中,只有一小部分实际上被开了这些药物:分别有 5.2%的患者服用 SGLT2i,6.0%的患者服用 GLP-1 RA。一般来说,服用这些研究药物或药物类别的患者的心血管疾病负担较低,而未服用这些药物的患者的心血管疾病负担较高。假设临床试验中的风险降低相似,如果 DCR 中的所有潜在试验合格患者接受恩格列净(或其他 SGLT2is,假设为类效应)或利拉鲁肽(或其他 GLP-1 RAs,假设为类效应)治疗 1 年,这可能分别预防了 354 例心血管死亡、231 例心力衰竭住院、329 例心血管死亡和 247 例心肌梗死。

结论

在一个大型的美国门诊登记处,我们发现有相当数量的患者可能有资格使用最近临床试验中显示心血管益处的降血糖药物。鉴于这些发现,应考虑在基于证据的患者人群中更广泛和更有针对性地使用这些药物。

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