Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial.
Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial.
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DOI：
10.1186/s12933-020-01127-z
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发表时间：
2020-09-25
影响因子：
9.3
通讯作者：
EMBODY trial investigators
中科院分区：
文献类型：
--
作者：
Shimizu W;Kubota Y;Hoshika Y;Mozawa K;Tara S;Tokita Y;Yodogawa K;Iwasaki YK;Yamamoto T;Takano H;Tsukada Y;Asai K;Miyamoto M;Miyauchi Y;Kodani E;Ishikawa M;Maruyama M;Ogano M;Tanabe J;EMBODY trial investigators
防止致死性室性心律失常导致心源性猝死（SCD）是急性心肌梗死（AMI）后的一个关键挑战。心脏交感和副交感神经活动可以使用心率变异性（HRV）和心率湍流（HRT）进行无创评估。该试验旨在确定钠-葡萄糖共转运蛋白2 （SGLT2）抑制剂是否能改善心脏神经活动。这项前瞻性、多中心、随机、双盲、安慰剂对照试验纳入了日本AMI和2型糖尿病（T2DM）患者；105例患者随机（1:1）接受每日一次10mg恩帕列净或安慰剂。主要终点是HRV的变化，例如，从基线到24周，所有5分钟平均正常RR间隔（SDANN）的标准差和低频与高频（LF/HF）之比。次要终点是其他心源性猝死（SCD）替代指标（如HRT）的变化。总共纳入96例患者（依帕列净组46例，安慰剂组50例）。恩格列净组和安慰剂组的SDANN变化分别为+ 11.6和+ 9.1 ms （P = 0.02）。恩格列净组和安慰剂组的LF/HF比值变化分别为- 0.57和- 0.17 (P = 0.01), P = 0.43。仅依帕列净组HRT有显著改善（P = 0.01）。而组间HRV和HRT比较显示恩格列净组和安慰剂组之间无显著差异。与安慰剂组相比，恩格列净组的体重、收缩压和尿酸显著降低。在恩格列净组中，未观察到不良事件。这是第一个评估恩格列净对T2DM和AMI患者心脏交感和副交感神经活动影响的随机临床数据。AMI合并T2DM患者早期给予SGLT2抑制剂可能有效改善心神经活动而无任何不良事件。试验注册：该试验于2017年11月在UMIN注册（ID: 000030158）。UMIN000030158;https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034442。
Protection from lethal ventricular arrhythmias leading to sudden cardiac death (SCD) is a crucial challenge after acute myocardial infarction (AMI). Cardiac sympathetic and parasympathetic activity can be noninvasively assessed using heart rate variability (HRV) and heart rate turbulence (HRT). The EMBODY trial was designed to determine whether the Sodium–glucose cotransporter 2 (SGLT2) inhibitor improves cardiac nerve activity. This prospective, multicenter, randomized, double-blind, placebo-controlled trial included patients with AMI and type 2 diabetes mellitus (T2DM) in Japan; 105 patients were randomized (1:1) to receive once-daily 10-mg empagliflozin or placebo. The primary endpoints were changes in HRV, e.g., the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency–to–high-frequency (LF/HF) ratio from baseline to 24 weeks. Secondary endpoints were changes in other sudden cardiac death (SCD) surrogate markers such as HRT. Overall, 96 patients were included (46, empagliflozin group; 50, placebo group). The changes in SDANN were + 11.6 and + 9.1 ms in the empagliflozin (P = 0.02) and placebo groups (P = 0.06), respectively. Change in LF/HF ratio was – 0.57 and – 0.17 in the empagliflozin (P = 0.01) and placebo groups (P = 0.43), respectively. Significant improvement was noted in HRT only in the empagliflozin group (P = 0.01). Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups. Compared with the placebo group, the empagliflozin group showed significant decreases in body weight, systolic blood pressure, and uric acid. In the empagliflozin group, no adverse events were observed. This is the first randomized clinical data to evaluate the effect of empagliflozin on cardiac sympathetic and parasympathetic activity in patients with T2DM and AMI. Early SGLT2 inhibitor administration in AMI patients with T2DM might be effective in improving cardiac nerve activity without any adverse events. Trial Registration: The EMBODY trial was registered by the UMIN in November 2017 (ID: 000030158). UMIN000030158; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034442.
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影响因子：
3.7
作者：
Chiba Y;Yamada T;Tsukita S;Takahashi K;Munakata Y;Shirai Y;Kodama S;Asai Y;Sugisawa T;Uno K;Sawada S;Imai J;Nakamura K;Katagiri H
通讯作者：
Katagiri H
影响因子：
8.4
作者：
Abe, Atsuko;Kobayashi, Kenzaburo;Ikeda, Takanori
通讯作者：
Ikeda, Takanori
影响因子：
2.4
作者：
Inzucchi SE;Zinman B;Wanner C;Ferrari R;Fitchett D;Hantel S;Espadero RM;Woerle HJ;Broedl UC;Johansen OE
通讯作者：
Johansen OE
DOI：
10.1007/s13300-018-0480-7
发表时间：
2018-10
期刊：
Diabetes therapy : research, treatment and education of diabetes and related disorders
影响因子：
--
作者：
Kubota Y;Yamamoto T;Tara S;Tokita Y;Yodogawa K;Iwasaki Y;Takano H;Tsukada Y;Asai K;Miyamoto M;Miyauchi Y;Kodani E;Sato N;Tanabe J;Shimizu W
通讯作者：
Shimizu W
影响因子：
5.8
作者：
Coleman, Ruth L.;Gray, Alastair M.;Holman, Rury R.
通讯作者：
Holman, Rury R.