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Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial.
Shimizu, Wataru; Kubota, Yoshiaki; Hoshika, Yu; Mozawa, Kosuke; Tara, Shuhei; Tokita, Yukichi; Yodogawa, Kenji; Iwasaki, Yu-Ki; Yamamoto, Takeshi; Takano, Hitoshi; Tsukada, Yayoi; Asai, Kuniya; Miyamoto, Masaaki; Miyauchi, Yasushi; Kodani, Eitaro; Ishikawa, Masahiro; Maruyama, Mitsunori; Ogano, Michio; Tanabe, Jun.
Afiliação
  • Shimizu W; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. wshimizu@nms.ac.jp.
  • Kubota Y; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Hoshika Y; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Mozawa K; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Tara S; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Tokita Y; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Yodogawa K; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Iwasaki YK; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Yamamoto T; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Takano H; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Tsukada Y; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Asai K; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Miyamoto M; Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
  • Miyauchi Y; Department of Cardiovascular Medicine, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan.
  • Kodani E; Department of Cardiovascular Medicine, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan.
  • Ishikawa M; Department of Cardiovascular Medicine, Nippon MEDICAL School Musashi Kosugi Hospital, Tokyo, Japan.
  • Maruyama M; Department of Cardiovascular Medicine, Nippon MEDICAL School Musashi Kosugi Hospital, Tokyo, Japan.
  • Ogano M; Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.
  • Tanabe J; Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.
Cardiovasc Diabetol ; 19(1): 148, 2020 09 25.
Article em En | MEDLINE | ID: mdl-32977831
ABSTRACT

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 (11) 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 .
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Sistema Nervoso Parassimpático / Sistema Nervoso Simpático / Compostos Benzidrílicos / Diabetes Mellitus Tipo 2 / Inibidores do Transportador 2 de Sódio-Glicose / Glucosídeos / Frequência Cardíaca / Infarto do Miocárdio Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Sistema Nervoso Parassimpático / Sistema Nervoso Simpático / Compostos Benzidrílicos / Diabetes Mellitus Tipo 2 / Inibidores do Transportador 2 de Sódio-Glicose / Glucosídeos / Frequência Cardíaca / Infarto do Miocárdio Idioma: En Ano de publicação: 2020 Tipo de documento: Article