当前位置: X-MOL 学术J. Am. Coll. Cardiol. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Randomized Trial of Empagliflozin in Non-Diabetic Patients with Heart Failure and Reduced Ejection Fraction
Journal of the American College of Cardiology ( IF 21.7 ) Pub Date : 2021-01-01 , DOI: 10.1016/j.jacc.2020.11.008
Carlos G Santos-Gallego 1 , Ariana P Vargas-Delgado 1 , Juan Antonio Requena-Ibanez 1 , Alvaro Garcia-Ropero 1 , Donna Mancini 2 , Sean Pinney 2 , Frank Macaluso 2 , Samantha Sartori 2 , Merce Roque 1 , Fernando Sabatel-Perez 1 , Anderly Rodriguez-Cordero 1 , M Urooj Zafar 1 , Icilma Fergus 2 , Farah Atallah-Lajam 2 , Johanna P Contreras 2 , Cathleen Varley 2 , Pedro R Moreno 2 , Vivian M Abascal 2 , Anuradha Lala 2 , Ronald Tamler 3 , Javier Sanz 2 , Valentin Fuster 4 , Juan J Badimon 1 ,
Affiliation  

BACKGROUND Large clinical trials established the benefits of SGLT2 inhibitors in patients with diabetes and with heart failure with reduced ejection fraction (HFrEF). The early and significant improvement in clinical outcomes is likely explained by effects beyond a reduction in hyperglycemia OBJECTIVES: To assess the effect of empagliflozin on LV function and volumes, functional capacity and quality of life (QoL) in non-diabetic HFrEF patients. METHODS In this double-blind, placebo-controlled trial, non-diabetic HFrEF patients (n=84) were randomized to empagliflozin or placebo for six months. The primary endpoint was change in left ventricle end-diastolic volume (LVEDV) and left ventricle end-systolic volume (LVESV) assessed by cardiac magnetic resonance. Secondary endpoints included changes in LV mass, LVEF, peak oxygen consumption in the cardiopulmonary exercise test, 6-minute walk test, and quality of life RESULTS: Empagliflozin was associated with a significant reduction of LVEDV (-25.1±26.0 vs -1.5±25.4mL for empagliflozin vs placebo, respectively, p<0.001) and LVESV (-26.6±20.5 vs -0.5±21.9 mL for empagliflozin vs placebo, p<0.001). Empagliflozin was associated with reductions in LV mass (-17.8±31.9 vs 4.1±13.4 g, for empagliflozin vs placebo, respectively, p<0.001) and improvements in LVEF (6±4.2 vs -0.1±3.9 p<0.001). Patients who received empagliflozin had significant improvements in peak O2 consumption (1.1±2.6 vs -0.5±1.9mL/min/kg for empagliflozin vs placebo, respectively, p=0.017), oxygen uptake efficiency slope (111±267 vs -146±318, p<0.001), as well as in 6-minute walk test (81±64 vs -35±68 meters, p<0.001) and quality of life (KCCQ-12: 21±18 vs 2±15, p<0.001). CONCLUSIONS Empagliflozin administration to non-diabetic HFrEF patients significantly improves LV volumes, LV mass, LV systolic function, functional capacity, and quality of life when compared with placebo. Our observations strongly support a role for SGLT2 inhibitors in the treatment of HFrEF patients independently of their glycemic status. CONDENSED ABSTRACT In this double-blind, placebo-controlled, randomized EMPATROPISM clinical trial, empagliflozin administration to non-diabetic HFrEF patients on top of optimal medical treatment ameliorated cardiac remodeling, reduced LV volumes, decreased LV mass, increased LV systolic function, enhanced functional capacity (both peak oxygen consumption and 6-minute walk test), and improved quality of life when compared with placebo. The results of the EMPATROPISM trial support the use of SGLT2 inhibitors in the treatment of HFrEF patients independently of their diabetic status.

中文翻译:

Empagliflozin 在心力衰竭和射血分数降低的非糖尿病患者中的随机试验

背景 大型临床试验证实了 SGLT2 抑制剂对糖尿病和射血分数降低的心力衰竭 (HFrEF) 患者的益处。临床结果的早期和显着改善可能通过降低高血糖以外的作用来解释 目标:评估恩格列净对非糖尿病 HFrEF 患者的 LV 功能和容量、功能容量和生活质量 (QoL) 的影响。方法 在这项双盲、安慰剂对照试验中,非糖尿病 HFrEF 患者(n=84)随机接受恩格列净或安慰剂治疗六个月。主要终点是通过心脏磁共振评估的左心室舒张末期容积 (LVEDV) 和左心室收缩末期容积 (LVESV) 的变化。次要终点包括 LV 质量、LVEF、心肺运动试验、6 分钟步行试验和生活质量中的峰值耗氧量 结果:恩格列净与 LVEDV 显着降低相关(恩格列净与安慰剂分别为 -25.1±26.0 和 -1.5±25.4mL,p< 0.001) 和 LVESV(-26.6±20.5 与 -0.5±21.9 mL,恩格列净与安慰剂,p<0.001)。Empagliflozin 与 LV 质量减少(-17.8±31.9 与 4.1±13.4 g,empagliflozin 与安慰剂,p<0.001)和 LVEF 改善相关(6±4.2 与 -0.1±3.9 p<0.001)。接受 empagliflozin 的患者在峰值 O2 消耗(恩格列净 vs 安慰剂分别为 1.1±2.6 和 -0.5±1.9mL/min/kg,p=0.017)、摄氧效率斜率(111±267 vs -146±318)方面有显着改善, p<0.001),以及在 6 分钟步行测试中(81±64 米对 -35±68 米,p<0。001) 和生活质量 (KCCQ-12: 21±18 vs 2±15, p<0.001)。结论 与安慰剂相比,对非糖尿病 HFrEF 患者给予 Empagliflozin 可显着改善 LV 容积、LV 质量、LV 收缩功能、功能能力和生活质量。我们的观察强烈支持 SGLT2 抑制剂在治疗 HFrEF 患者中的作用,而与他们的血糖状态无关。浓缩摘要 在这项双盲、安慰剂对照、随机 EMPATROPISM 临床试验中,在最佳药物治疗的基础上对非糖尿病 HFrEF 患者使用恩格列净可改善心脏重构、减少 LV 容积、减少 LV 质量、增加 LV 收缩功能、增强功能容量(峰值耗氧量和 6 分钟步行测试),并与安慰剂相比提高了生活质量。
更新日期:2021-01-01
down
wechat
bug