PMID- 34236577 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210821 IS - 1869-6953 (Print) IS - 1869-6961 (Electronic) IS - 1869-6961 (Linking) VI - 12 IP - 8 DP - 2021 Aug TI - Effect of Empagliflozin Versus Placebo on Plasma Volume Status in Patients with Acute Myocardial Infarction and Type 2 Diabetes Mellitus. PG - 2241-2248 LID - 10.1007/s13300-021-01103-0 [doi] AB - INTRODUCTION: Plasma volume status (PVS), a parameter of the discrepancy between actual plasma volume (PV) and ideal PV, has been recently evaluated as a prognostic marker in patients with heart failure. This subgroup analysis of the EMBODY trial was designed to determine whether a sodium-glucose cotransporter 2 (SGLT2) inhibitor affects the alleviation of heart failure and improvement of PVS in patients after acute myocardial infarction (AMI) with congestive heart failure (CHF). METHODS: The EMBODY trial was a prospective, multicenter, randomized, double-blind, placebo-controlled trial to identify the effect of an SGLT2 inhibitor on cardiac sympathetic hyperactivity in patients with AMI and type 2 diabetes mellitus (T2DM) in Japan. In total, 105 patients were randomized (1:1) to receive 10 mg empagliflozin or a placebo (once daily), 2 weeks after the onset of AMI. In this subanalysis, we investigated the time-course of PVS at baseline and weeks 4, 12, and 24. RESULTS: Overall, 96 patients were included in the subgroup analysis set (age 64.3 +/- 10.9 years, 80.2% men; 46 in the empagliflozin group and 50 in the placebo group). Body weight and PVS decreased in the empagliflozin group compared with the placebo group at 24 weeks (- 2.2 vs. + 0.1 kg, P < 0.001, and - 5.1 vs. - 0.3%, P < 0.001, respectively). Decreased PVS, defined as a change in PVS of < - 4.5%, was associated with the administration of empagliflozin (odds ratio 2.61, 95% confidence interval 1.11-6.15, P = 0.028). N-terminal pro b-type natriuretic peptide levels decreased in both the empagliflozin and placebo groups (1028.7-370.3 pg/mL, P < 0.001, and 1270.6-673.7 pg/mL, P < 0.01, respectively). CONCLUSION: Empagliflozin reduced the body weight and PVS. Early SGLT2 inhibitor administration in patients with AMI, CHF, and T2DM can therefore be effective in reducing the body weight and PVS. TRIAL REGISTRATION: UMIN 000030158. CI - (c) 2021. The Author(s). FAU - Hoshika, Yu AU - Hoshika Y AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Kubota, Yoshiaki AU - Kubota Y AUID- ORCID: 0000-0001-7320-7641 AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. ykubota@nms.ac.jp. FAU - Mozawa, Kosuke AU - Mozawa K AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Tara, Shuhei AU - Tara S AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Tokita, Yukichi AU - Tokita Y AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Yodogawa, Kenji AU - Yodogawa K AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Iwasaki, Yu-Ki AU - Iwasaki YK AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Yamamoto, Takeshi AU - Yamamoto T AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Takano, Hitoshi AU - Takano H AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Tsukada, Yayoi AU - Tsukada Y AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Asai, Kuniya AU - Asai K AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Miyamoto, Masaaki AU - Miyamoto M AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. FAU - Miyauchi, Yasushi AU - Miyauchi Y AD - Department of Cardiovascular Medicine, Nippon Medical School-Chiba Hokuso Hospital, Chiba, Japan. FAU - Kodani, Eitaro AU - Kodani E AD - Department of Cardiovascular Medicine, Nippon Medical School-Tama Nagayama Hospital, Tokyo, Japan. FAU - Maruyama, Mitsunori AU - Maruyama M AD - Department of Cardiovascular Medicine, Nippon Medical School-Musashi Kosugi Hospital, Tokyo, Japan. FAU - Tanabe, Jun AU - Tanabe J AD - Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan. FAU - Shimizu, Wataru AU - Shimizu W AD - Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. LA - eng GR - 1245-0175/Boehringer Ingelheim/ GR - 1245-0175/Eli Lilly and Company/ PT - Journal Article DEP - 20210708 PL - United States TA - Diabetes Ther JT - Diabetes therapy : research, treatment and education of diabetes and related disorders JID - 101539025 PMC - PMC8342682 OTO - NOTNLM OT - Acute myocardial infarction OT - Congestive heart failure OT - Empagliflozin OT - Plasma volume status OT - Sodium-glucose cotransporter 2 (SGLT2) inhibitor EDAT- 2021/07/09 06:00 MHDA- 2021/07/09 06:01 PMCR- 2021/07/08 CRDT- 2021/07/08 12:27 PHST- 2021/05/17 00:00 [received] PHST- 2021/06/15 00:00 [accepted] PHST- 2021/07/09 06:00 [pubmed] PHST- 2021/07/09 06:01 [medline] PHST- 2021/07/08 12:27 [entrez] PHST- 2021/07/08 00:00 [pmc-release] AID - 10.1007/s13300-021-01103-0 [pii] AID - 1103 [pii] AID - 10.1007/s13300-021-01103-0 [doi] PST - ppublish SO - Diabetes Ther. 2021 Aug;12(8):2241-2248. doi: 10.1007/s13300-021-01103-0. Epub 2021 Jul 8.