論文

査読有り 本文へのリンクあり 国際誌
2020年9月25日

Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: The EMBODY trial

Cardiovascular Diabetology
  • Wataru Shimizu
  • Yoshiaki Kubota
  • Yu Hoshika
  • Kosuke Mozawa
  • Shuhei Tara
  • Yukichi Tokita
  • Kenji Yodogawa
  • Yu Ki Iwasaki
  • Takeshi Yamamoto
  • Hitoshi Takano
  • Yayoi Tsukada
  • Kuniya Asai
  • Masaaki Miyamoto
  • Yasushi Miyauchi
  • Eitaro Kodani
  • Masahiro Ishikawa
  • Mitsunori Maruyama
  • Michio Ogano
  • Jun Tanabe
  • Reiko Shiomura
  • Isamu Fukuizumi
  • Junya Matsuda
  • Satsuki Noma
  • Hideto Sangen
  • Hidenori Komiyama
  • Yoichi Imori
  • Shunichi Nakamura
  • Jun Nakata
  • Hideki Miyachi
  • Gen Takagi
  • Takahiro Todoroki
  • Takeshi Ikeda
  • Tomoyo Miyakuni
  • Ayaka Shima
  • Masato Matsushita
  • Hirotake Okazaki
  • Akihiro Shirakabe
  • Nobuaki Kobayashi
  • Masamitsu Takano
  • Yoshihiko Seino
  • Yugo Nishi
  • Keishi Suzuki
  • Junsuke Shibuya
  • Tsunenori Saito
  • Hiroyuki Nakano
  • Morisawa Taichirou
  • Erito Furuse
  • Kenji Nakama
  • Yusuke Hosokawa
  • Ippei Tsuboi
  • Hidekazu Kawanaka
  • 全て表示

19
1
開始ページ
148
終了ページ
148
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1186/s12933-020-01127-z

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 .

リンク情報
DOI
https://doi.org/10.1186/s12933-020-01127-z
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/32977831
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519555
Scopus
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85091807646&origin=inward 本文へのリンクあり
Scopus Citedby
https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85091807646&origin=inward
ID情報
  • DOI : 10.1186/s12933-020-01127-z
  • eISSN : 1475-2840
  • PubMed ID : 32977831
  • PubMed Central 記事ID : PMC7519555
  • SCOPUS ID : 85091807646

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