METHODS: This study comprised prespecified and post-hoc analyses of the EMPA-REG OUTCOME trial in which 7020 people with type 2 diabetes (T2D) and cardiovascular disease [mostly atherosclerotic (ASCVD)] were randomized to empagliflozin or placebo and followed for a median 3.1 years. We assessed the effect of empagliflozin on total (first plus recurrent) events of centrally adjudicated fatal and non-fatal myocardial infarction (MI) using a negative binomial model with robust confidence intervals (CI) that preserves randomization and accounts for the within-patient correlation of multiple events. Post hoc, we analyzed types of MI: type 1 (related to plaque-rupture/thrombus), type 2 (myocardial supply-demand imbalance), type 3 (sudden-death related, i.e. fatal MI), type 4 (percutaneous coronary intervention-related), and type 5 (coronary artery bypass graft-related). MIs could be assigned to > 1 type.
RESULTS: There were 421 total MIs (including recurrent); 299, 86, 26, 19, and 1 were classified as type 1, 2, 3, 4, and 5 events, respectively. Overall, empagliflozin reduced the risk of total MI events by 21% [rate ratio for empagliflozin vs. placebo, 0.79 (95% CI, 0.620-0.998), P = 0.0486], largely driven by its effect on type 1 [rate ratio, 0.79 (95% CI, 0.61-1.04)] and type 2 MIs [rate ratio, 0.67 (95% CI, 0.41-1.10)].
CONCLUSIONS: In T2D patients with ASCVD, empagliflozin reduced the risk of MIs, with consistent effects across the two most common etiologies, i.e. type 1 and 2.
BACKGROUND: URL: https://www.
RESULTS: gov ; Unique identifier: NCT01131676.
方法:这项研究包括对EMPA-REGOUTCOME试验的预设和事后分析,其中7020名2型糖尿病(T2D)和心血管疾病(主要是动脉粥样硬化(ASCVD))患者被随机分配给依帕列净或安慰剂,并随访平均3.1年。我们使用具有稳健置信区间(CI)的负二项模型评估了依帕列净对中央裁定的致命性和非致命性心肌梗死(MI)的总(首次和复发)事件的影响,该模型保留了随机化并考虑了多个事件的患者内部相关性。事后,我们分析了MI的类型:1型(与斑块破裂/血栓有关),2型(心肌供需失衡),类型3(猝死相关,即致命MI),类型4(经皮冠状动脉介入治疗相关),和5型(冠状动脉旁路移植术相关)。可以将MI分配给>1类型。
结果:总共421个MI(包括复发);299、86、26、19和1分为1、2、3、4和5型事件,分别。总的来说,empagliflozin将总MI事件的风险降低了21%[empagliflozin与empagliflozin的比率安慰剂,0.79(95%CI,0.620-0.998),P=0.0486],很大程度上是由其对类型1[比率的影响驱动的,0.79(95%CI,0.61-1.04)]和2型MIs[比率,0.67(95%CI,0.41-1.10)]。
结论:在患有ASCVD的T2D患者中,empagliflozin降低了MI的风险,在两种最常见的病因上有一致的影响,即类型1和类型2。
背景:URL:https://www。
结果:gov;唯一标识符:NCT01131676。