Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease The EMPA-HEART CardioLink-6 Randomized Clinical Trial
Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease The EMPA-HEART CardioLink-6 Randomized Clinical Trial
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DOI：
10.1161/circulationaha.119.042375
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发表时间：
2019-11-19
期刊：
影响因子：
37.8
通讯作者：
Connelly, Kim A.
中科院分区：
文献类型：
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作者：
Verma, Subodh;Mazer, C. David;Connelly, Kim A.
背景：SGLT2（钠-葡萄糖共转运蛋白2）抑制剂可降低2型糖尿病患者的心血管事件，但它们是否促进心脏的直接作用仍不清楚。我们试图确定恩格列净是否导致2型糖尿病和冠状动脉疾病患者左心室（LV）质量的降低。方法：2016年11月至2018年4月，我们招募了97名个体，>= 40和= 60mL/min/ 173 m(2)。除了标准治疗外，参与者被随机分配到恩格列净（10mg /天，n=49）或安慰剂（n=48），持续6个月。主要结局是6个月的左室质量与体表面积的变化，这是通过心脏磁共振成像测量的。其他测量包括6个月左室舒张末期和收缩期容积的变化，这些变化与体表面积、射血分数、24小时动态血压、红细胞压积和NT-proBNP （n端前b型利钠肽）有关。结果：在97名参与者中(90名男性[93%]，平均[标准差]年龄62.8[9.0]岁，2型糖尿病病程11.0[8.2]年，估计肾小球滤过率88.4 [16.9]mL/min/1.73m(2)，左室质量与体表面积指数为60.7 [11.9]g/m(2))， 90名随访时具有可评估的影像学。恩格列净组和安慰剂组6个月内与体表面积回归指数相关的平均左室质量分别为2.6 g/m(2)和0.01 g/m(2)(调整差-3.35 g/m(2)；95% CI, -5.9 ~ -0.81g/m(2)， P=0.01)。在恩格列净组中，总体动态收缩压（调整差值-6.8mmHg, 95% CI -11.2 ~ -2.3mmHg， P=0.003）、舒张压（调整差值-3.2mmHg, 95% CI, -5.8 ~ -0.6mmHg， P=0.02）和红细胞压比升高（P=0.0003）显著降低。结论：在2型糖尿病和冠状动脉疾病患者中，恩帕列净抑制SGLT2与6个月后以体表面积为指标的左室质量显著降低相关，这可能部分解释了EMPA-REG OUTCOME （BI 10773[恩帕列净]2型糖尿病患者心血管结局事件试验）试验中观察到的有益心血管结局。
Background: SGLT2 (sodium-glucose cotransporter 2) inhibitors lower cardiovascular events in type 2 diabetes mellitus but whether they promote direct cardiac effects remains unknown. We sought to determine if empagliflozin causes a decrease in left ventricular (LV) mass in people with type 2 diabetes mellitus and coronary artery disease. Methods: Between November 2016 and April 2018, we recruited 97 individuals >= 40 and = 60mL/min/1.73m(2). The participants were randomized to empagliflozin (10 mg/day, n=49) or placebo (n=48) for 6 months, in addition to standard of care. The primary outcome was the 6-month change in LV mass indexed to body surface area from baseline as measured by cardiac magnetic resonance imaging. Other measures included 6-month changes in LV end-diastolic and -systolic volumes indexed to body surface area, ejection fraction, 24-hour ambulatory blood pressure, hematocrit, and NT-proBNP (N-terminal pro b-type natriuretic peptide). Results: Among the 97 participants (90 men [93%], mean [standard deviation] age 62.8 [9.0] years, type 2 diabetes mellitus duration 11.0 [8.2] years, estimated glomerular filtration rate 88.4 [16.9] mL/min/1.73m(2), LV mass indexed to body surface area 60.7 [11.9] g/m(2)), 90 had evaluable imaging at follow-up. Mean LV mass indexed to body surface area regression over 6 months was 2.6 g/m(2) and 0.01 g/m(2) for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35 g/m(2); 95% CI, -5.9 to -0.81g/m(2), P=0.01). In the empagliflozin-allocated group, there was significant lowering of overall ambulatory systolic blood pressure (adjusted difference -6.8mmHg, 95% CI -11.2 to -2.3mmHg, P=0.003), diastolic blood pressure (adjusted difference -3.2mmHg; 95% CI, -5.8 to -0.6mmHg, P=0.02) and elevation of hematocrit (P=0.0003). Conclusions: Among people with type 2 diabetes mellitus and coronary artery disease, SGLT2 inhibition with empagliflozin was associated with significant reduction in LV mass indexed to body surface area after 6 months, which may account in part for the beneficial cardiovascular outcomes observed in the EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) trial.