Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, Graz, Austria.
Medical University of Graz, Department of Internal Medicine, Division of Cardiology, Graz, Austria.
Am Heart J. 2020 Mar;221:39-47. doi: 10.1016/j.ahj.2019.12.004. Epub 2019 Dec 12.
Sodium glucose cotransporter 2 (SGLT2) inhibitors are established antidiabetic drugs with proven cardiovascular benefit. Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocardial infarction (AMI) has not been investigated yet. Therefore, the impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY) trial was designed to investigate the efficacy and safety of empagliflozin in diabetic and non-diabetic patients after severe AMI.
Within a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.
The EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. Results will provide the rationale for the conduct of a cardiovascular outcome trial to test the effect of empagliflozin in patients with AMI.
钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂是已被证实具有心血管益处的抗糖尿病药物。尽管越来越多的证据表明其对心肌重构、液体平衡和心功能具有有益作用，但早期急性心肌梗死（AMI）后起始应用恩格列净的影响尚未得到研究。因此，设计了急性心肌梗死后早期应用恩格列净对心脏功能和心力衰竭生物标志物的影响（EMMY）试验，旨在研究恩格列净在严重 AMI 后糖尿病和非糖尿病患者中的疗效和安全性。
在一项多中心、随机、双盲、安慰剂对照的 3b 期试验中，我们将招募 AMI 患者，且具有严重心肌坏死特征的患者以 1:1 的比例随机分为恩格列净（10mg 每日 1 次）或匹配安慰剂组。主要终点是恩格列净对 AMI 后 6 个月内 NT-proBNP 变化的影响。次要终点包括超声心动图参数、酮体浓度、HbA1c 水平和体重的变化，分别为。因心力衰竭或其他原因住院率、住院时间和全因死亡率将作为探索性次要终点进行评估。
EMMY 试验将在无论其糖尿病状态如何的 AMI 患者中测试恩格列净。因此，EMMY 试验可能支持 SGLT2 抑制改善心脏重构、前负荷和后负荷以及心脏代谢的概念，而不考虑其抗糖尿病作用。结果将为进行心血管结局试验以测试 AMI 患者恩格列净的效果提供依据。
