在 EMPA-REG OUTCOME 中，动脉粥样硬化性心血管疾病诊断合格与否对心血管风险和安格列酮治疗效果的影响

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

CJC Open Pub Date : 2024-07-01 DOI:10.1016/j.cjco.2024.01.013

Ayodele Odutayo MD, DPhil , Bernard Zinman MD , Christoph Wanner MD , Isabella Zwiener PhD , Søren S. Lund MD , Stefan Hantel PhD , David Fitchett MD , Jacob A. Udell MD , EMPA-REG OUTCOME Trial Investigators

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引用次数: 0

摘要

背景在2型糖尿病（T2DM）患者中，缺血性事件史与心血管疾病（CV）风险增加有关。本研究是对恩格列净心血管结果事件试验（Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients-Removing Excess Glucose，EMPA-REG OUTCOME）的二次分析，该试验比较了恩格列净和安慰剂对患有T2DM和动脉粥样硬化性心血管疾病（ASCVD）的成人的治疗效果。参与者根据距上一次合格的 ASCVD 诊断时间（≤ 1 年 vs > 1 年）进行分类。合格的 ASCVD 诊断包括缺血性或出血性中风、心肌梗死、冠状动脉疾病和外周动脉疾病。主要结果是冠心病死亡、非致死性心肌梗死或非致死性卒中的复合结果。结果共纳入 6796 名参与者（n = 4547 名恩格列净患者，n = 2249 名安慰剂患者）。距上次确诊ASCVD的中位时间为3.8年（1-3分位数：1.5-7.6），大多数确诊发生在随机化前1年（≤1年，n=1214；> 1年，n=5582）。无论距上一次ASCVD诊断合格时间长短，恩格列净都能降低主要结局的发生率（≤1年：危险比0.82，95%置信区间：0.57-1.16；vs > 1年：危险比0.85，95%置信区间：0.72-1.00；交互作用P=0.84）。结论Empagliflozin能改善T2DM患者的CV预后，与随机分组时最后一次合格的ASCVD诊断时间无关。有必要开展前瞻性试验，研究在发生急性 ASCVD 事件时使用钠-葡萄糖协同转运体 2 抑制剂的情况。试验注册EMPA-REG OUTCOME（Clinicaltrials.gov 标识符：NCT01131676）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Effect of Qualifying Atherosclerotic Cardiovascular Disease Diagnosis Proximity on Cardiovascular Risk and Benefit of Empagliflozin in the EMPA-REG OUTCOME Trial

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Effect of Qualifying Atherosclerotic Cardiovascular Disease Diagnosis Proximity on Cardiovascular Risk and Benefit of Empagliflozin in the EMPA-REG OUTCOME Trial

Background

In patients with type 2 diabetes mellitus (T2DM), a history of an ischemic event is associated with increased risk for cardiovascular (CV) disease. Whether patients with T2DM and a recent atherothrombotic diagnosis benefit from early intervention with a sodium-glucose co-transporter 2 inhibitor is unknown.

Methods

This study is a secondary analysis of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients–Removing Excess Glucose (EMPA-REG OUTCOME), which compared empagliflozin to placebo in adults with T2DM and atherosclerotic CV disease (ASCVD). Participants were categorized based on the time since their last qualifying ASCVD diagnosis (≤ 1 year vs > 1 year). Qualifying ASCVD diagnoses included ischemic or hemorrhagic stroke, myocardial infarction, coronary artery disease, and peripheral artery disease. The primary outcome was a composite of CV death, nonfatal myocardial infarction, or nonfatal stroke.

Results

A total of 6796 participants (n = 4547 empagliflozin, n = 2249 placebo) were included. Median time since the last qualifying ASCVD diagnosis was 3.8 years (quartile 1-quartile 3: 1.5-7.6), and most qualifying diagnoses occurred > 1 year before randomization (≤ 1 year, n = 1214; > 1 year, n = 5582). Empagliflozin reduced the incidence of the primary outcome irrespective of the time since the last qualifying ASCVD diagnosis (≤ 1 year: hazard ratio 0.82, 95% confidence interval: 0.57-1.16; vs > 1 year: hazard ratio 0.85, 95% confidence interval: 0.72-1.00; P for interaction = 0.84). Results were similar for the composite of CV death or hospitalization for heart failure.

Conclusions

Empagliflozin improved CV outcomes in participants with T2DM, irrespective of the time since the last qualifying ASCVD diagnosis at randomization. Prospective trials are necessary to investigate the use of sodium-glucose co-transporter 2 inhibitors at the time of an acute ASCVD event.