Effect of Empagliflozin on Left Ventricular Volumes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure With Reduced Ejection Fraction (SUGAR-DM-HF).
Effect of Empagliflozin on Left Ventricular Volumes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure With Reduced Ejection Fraction (SUGAR-DM-HF).
复制标题
恩格列净对2型糖尿病或糖尿病前期伴射血分数降低心力衰竭（SUGAR-DM-HF）患者左心室肥厚的影响。
DOI：
10.1161/circulationaha.120.052186
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发表时间：
2021-02-09
期刊：
影响因子：
37.8
通讯作者：
Sattar N
中科院分区：
文献类型：
--
作者：
Lee MMY;Brooksbank KJM;Wetherall K;Mangion K;Roditi G;Campbell RT;Berry C;Chong V;Coyle L;Docherty KF;Dreisbach JG;Labinjoh C;Lang NN;Lennie V;McConnachie A;Murphy CL;Petrie CJ;Petrie JR;Speirits IA;Sourbron S;Welsh P;Woodward R;Radjenovic A;Mark PB;McMurray JJV;Jhund PS;Petrie MC;Sattar N
文本中提供了补充数字内容。钠-葡萄糖协同转运蛋白 2 抑制剂可降低心力衰竭和射血分数降低 (HFrEF) 患者心力衰竭住院和心血管死亡的风险。然而，它们对 HFrEF 心脏结构和功能的影响尚不确定。我们设计了一项多中心、随机、双盲、安慰剂对照试验（SUGAR-DM-HF 试验[恩格列净及其对糖尿病或糖尿病前期和心力衰竭患者的心血管、肾脏和代谢影响的研究]），以研究恩格列净对纽约心脏协会功能分级 II 至 IV 级左心室患者的心脏影响 (LV)射血分数≤40%且2型糖尿病或糖尿病前期。患者按年龄（<65 岁和≥65 岁）和血糖状况（糖尿病或糖尿病前期）分层，以 1:1 的比例随机分配至恩格列净 10 mg 每日一次或安慰剂组。共同主要结果是 36 周时与体表面积相关的 LV 收缩末期容积和 LV 整体纵向应变（均使用心血管磁共振测量）的变化。次要疗效结果包括其他心血管磁共振测量（左心室舒张末期容积指数、左心室射血分数）、利尿强化、症状（堪萨斯城心肌病问卷总症状评分、6 分钟步行距离、肺部超声 B 线和生物标志物（包括 N 端 B 型利钠肽原）。 2018年至2019年8月，105名患者被随机分配：平均年龄68.7（SD，11.1）岁，77名（73.3％）男性，82名（78.1％）糖尿病患者和23名（21.9％）糖尿病前期患者，平均左心室射血分数32.5％（9.8％），以及81名（77.1％）纽约心脏协会II和24 (22.9%) 纽约心脏协会 III。患者收到 HFrEF 的标准治疗。与安慰剂相比，恩格列净使 LV 收缩末期容积指数降低 6.0（95% CI，–10.8 至 –1.2）mL/m2（P=0.015）。左心室整体纵向应变没有差异。恩格列净使 LV 舒张末期容积指数降低 8.2（95% CI，–13.7 至 –2.6) mL/m2 (P=0.0042)，N 端 B 型利钠肽原减少 28% (2%–47%)，P=0.038。其他心血管磁共振测量、利尿强化、堪萨斯城心肌病问卷总症状评分、6 分钟步行距离或 B 线。钠-葡萄糖协同转运蛋白 2 抑制剂恩格列净可降低 HFrEF 和 2 型糖尿病或糖尿病前期患者的左心室体积。有利的逆向左心室重构可能是钠-葡萄糖协同转运蛋白 2 抑制剂减少 HFrEF 心力衰竭住院率和死亡率的机制。网址： https://www.clinicaltrials.gov。唯一标识符：NCT03485092。
Supplemental Digital Content is available in the text. Sodium-glucose cotransporter 2 inhibitors reduce the risk of heart failure hospitalization and cardiovascular death in patients with heart failure and reduced ejection fraction (HFrEF). However, their effects on cardiac structure and function in HFrEF are uncertain. We designed a multicenter, randomized, double-blind, placebo-controlled trial (the SUGAR-DM-HF trial [Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus, or Prediabetes, and Heart Failure]) to investigate the cardiac effects of empagliflozin in patients in New York Heart Association functional class II to IV with a left ventricular (LV) ejection fraction ≤40% and type 2 diabetes or prediabetes. Patients were randomly assigned 1:1 to empagliflozin 10 mg once daily or placebo, stratified by age (<65 and ≥65 years) and glycemic status (diabetes or prediabetes). The coprimary outcomes were change from baseline to 36 weeks in LV end-systolic volume indexed to body surface area and LV global longitudinal strain both measured using cardiovascular magnetic resonance. Secondary efficacy outcomes included other cardiovascular magnetic resonance measures (LV end-diastolic volume index, LV ejection fraction), diuretic intensification, symptoms (Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, B-lines on lung ultrasound, and biomarkers (including N-terminal pro-B-type natriuretic peptide). From April 2018 to August 2019, 105 patients were randomly assigned: mean age 68.7 (SD, 11.1) years, 77 (73.3%) male, 82 (78.1%) diabetes and 23 (21.9%) prediabetes, mean LV ejection fraction 32.5% (9.8%), and 81 (77.1%) New York Heart Association II and 24 (22.9%) New York Heart Association III. Patients received standard treatment for HFrEF. In comparison with placebo, empagliflozin reduced LV end-systolic volume index by 6.0 (95% CI, –10.8 to –1.2) mL/m2 (P=0.015). There was no difference in LV global longitudinal strain. Empagliflozin reduced LV end-diastolic volume index by 8.2 (95% CI, –13.7 to –2.6) mL/m2 (P=0.0042) and reduced N-terminal pro-B-type natriuretic peptide by 28% (2%–47%), P=0.038. There were no between-group differences in other cardiovascular magnetic resonance measures, diuretic intensification, Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, or B-lines. The sodium-glucose cotransporter 2 inhibitor empagliflozin reduced LV volumes in patients with HFrEF and type 2 diabetes or prediabetes. Favorable reverse LV remodeling may be a mechanism by which sodium-glucose cotransporter 2 inhibitors reduce heart failure hospitalization and mortality in HFrEF. URL: https://www.clinicaltrials.gov. Unique identifier: NCT03485092.