Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPA-ICD) in Patients with Type 2 Diabetes (T2DM): Rationale and Design View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-09-23

AUTHORS

Shinya Fujiki, Kenichi Iijima, Masaaki Okabe, Shinichi Niwano, Kenichi Tsujita, Shigeto Naito, Kenji Ando, Kengo Kusano, Ritsushi Kato, Junichi Nitta, Tetsuji Miura, Takeshi Mitsuhashi, Kazuomi Kario, Yusuke Kondo, Masaki Ieda, Nobuhisa Hagiwara, Toyoaki Murohara, Kazuyoshi Takahashi, Hirofumi Tomita, Yasuchika Takeishi, Toshihisa Anzai, Wataru Shimizu, Masafumi Watanabe, Yoshihiro Morino, Takeshi Kato, Hiroshi Tada, Yoshihisa Nakagawa, Masafumi Yano, Koji Maemura, Takeshi Kimura, Hisako Yoshida, Keiko Ota, Takahiro Tanaka, Nobutaka Kitamura, Koichi Node, Yoshifusa Aizawa, Ippei Shimizu, Daisuke Izumi, Kazuyuki Ozaki, Tohru Minamino

ABSTRACT

IntroductionType 2 diabetes (T2DM) is associated with cardiovascular death, including sudden cardiac death due to arrhythmias. Patients with an implantable cardioverter-defibrillator (ICD) are also at high risk of developing a clinically significant ventricular arrhythmia. It has been reported that sodium–glucose cotransporter 2 (SGLT2) inhibitors can reduce cardiovascular deaths; however, the physiological mechanisms of this remain unclear. It is, however, well known that SGLT2 inhibitors increase blood ketone bodies, which have been suggested to have sympatho-suppressive effects. Empagliflozin (EMPA) is an SGLT2 inhibitor. The current clinical trial titled “Placebo-controlled, double-blind study of empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD) in patients with type 2 diabetes (T2DM)” was designed to investigate the antiarrhythmic effects of EMPA.MethodsThe EMPA-ICD study is a prospective, multicenter, placebo-controlled, double-blind, randomized, investigator-initiated clinical trial currently in progress. A total of 210 patients with T2DM (hemoglobin A1c 6.5–10.0%) will be randomized (1:1) to receive once-daily placebo or EMPA, 10 mg, for 24 weeks. The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD. The secondary endpoints of the study are the change from baseline concentrations in blood ketone and catecholamine 24 weeks after drug treatment.ConclusionThe EMPA-ICD study is the first clinical trial to assess the effect of an SGLT2 inhibitor on clinically significant ventricular arrhythmias in patients with T2DM and an ICD.Trial registrationUnique trial number, jRCTs031180120 (https://jrct.niph.go.jp/latest-detail/jRCTs031180120). More... »

PAGES

2739-2755

Journal

TITLE

Diabetes Therapy

ISSUE

11

VOLUME

11

Author Affiliations

  • Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
  • Department of Cardiology, Tachikawa General Hospital, Nagaoka, Niigata, Japan
  • Cardiovascular Medicine, Kitasato University, Sagamihara, Kanagawa, Japan
  • Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan
  • Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi, Gunma, Japan
  • Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan
  • Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan
  • Department of Arrhythmia, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan
  • Department of Cardiology, Sakakibara Heart Institute, Fuchu, Tokyo, Japan
  • Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan
  • Department of Cardiology, Jichi Medical University Saitama Medical Center, Saitama, Japan
  • Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan
  • Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan
  • Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan
  • Department of Cardiology, Tokyo Women’s Medical University, Tokyo, Japan
  • Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan
  • Department of Cardiology, Niigata City General Hospital, Niigata, Japan
  • Department of Cardiology and Nephrology, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan
  • Department of Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan
  • Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan
  • Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan
  • Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine, Yamagata, Japan
  • Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Morioka, Iwate, Japan
  • Department of Cardiology, Graduate School of Medical Science, Kanazawa University, Kanazawa, Ishikawa, Japan
  • Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan
  • Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan
  • Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan
  • Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
  • Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
  • Department of Medial Statistics, Osaka City University, Graduate School of Medicine, Osaka, Japan
  • Data Management Group, Department of Clinical Research Support, Center for Clinical Research and Innovation, Osaka City University Hospital, Osaka, Japan
  • Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan
  • Department of Cardiovascular Medicine, Saga University, Saga, Japan
  • Divisiont of Molecular Aging and Cell Biology, Niigata University Graduate School of Medical and Dental Sciences, 951-8510, Niigata, Japan
  • Japan Agency for Medical Research and Development-Core Research for Evolutionary Medical Science and Technology (AMED-CREST), Japan Agency for Medical Research and Development, Tokyo, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s13300-020-00924-9

    DOI

    http://dx.doi.org/10.1007/s13300-020-00924-9

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1131134507

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/32968947


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