Effect of empagliflozin on ventricular arrhythmias in patients with type 2 diabetes treated with an implantable cardioverter-defibrillator: the EMPA-ICD trial

被引：12

作者：

Fujiki, Shinya ^{[1
]}

Iijima, Kenichi ^{[2
]}

Nakagawa, Yoshihisa ^{[3
]}

Takahashi, Kazuyoshi ^{[4
]}

Okabe, Masaaki ^{[5
]}

Kusano, Kengo ^{[6
]}

Owada, Shingen ^{[7
]}

Kondo, Yusuke ^{[8
]}

Tsujita, Kenichi ^{[9
]}

Shimizu, Wataru ^{[10
]}

Tomita, Hirofumi ^{[11
]}

Watanabe, Masaya ^{[12
]}

Shoda, Morio ^{[13
]}

Watanabe, Masafumi ^{[14
]}

Tokano, Takashi ^{[15
]}

Murohara, Toyoaki ^{[16
]}

Kaneshiro, Takashi ^{[17
]}

Kato, Takeshi ^{[18
]}

Hayashi, Hidemori ^{[2
]}

Maemura, Koji ^{[19
]}

Niwano, Shinichi ^{[20
]}

Umemoto, Tomio ^{[21
]}

Yoshida, Hisako ^{[22
]}

Ota, Keiko ^{[23
]}

Tanaka, Takahiro ^{[24
]}

Kitamura, Nobutaka ^{[24
]}

Node, Koichi ^{[25
]}

Minamino, Tohru ^{[1
,2
,26
]}

机构：

[1] Niigata Univ, Grad Sch Med & Dent Sci, Dept Cardiovasc Med, Niigata, Japan

[2] Juntendo Univ, Grad Sch Med, Dept Cardiovasc Biol & Med, 2-1-1 Hongo,Bunkyo Ku, Tokyo 1138421, Japan

[3] Shiga Univ Med Sci, Dept Cardiovasc Med, Otsu, Shiga, Japan

[4] Niigata City Gen Hosp, Dept Cardiol, Niigata, Japan

[5] Tachikawa Gen Hosp, Dept Cardiol, Niigata, Japan

[6] Natl Cerebral & Cardiovasc Ctr, Dept Cardiovasc Med, Osaka, Japan

[7] Iwate Med Univ, Dept Internal Med, Div Cardiol, Yahaba, Iwate, Japan

[8] Chiba Univ, Grad Sch Med, Dept Cardiovasc Med, Chiba, Japan

[9] Kumamoto Univ, Grad Sch Med Sci, Dept Cardiovasc Med, Kumamoto, Japan

[10] Nippon Med Sch, Dept Cardiovasc Med, Tokyo, Japan

[11] Hirosaki Univ, Grad Sch Med, Dept Cardiol & Nephrol, Hirosaki, Aomori, Japan

[12] Hokkaido Univ, Grad Sch Med, Dept Cardiovasc Med, Sapporo, Hokkaido, Japan

[13] Tokyo Womens Med Univ Hosp, Dept Cardiol, Tokyo, Japan

[14] Yamagata Univ, Fac Med, Dept Cardiol Pulmonol & Nephrol, Yamagata, Japan

[15] Juntendo Univ, Urayasu Hosp, Dept Cardiol, Chiba, Japan

[16] Nagoya Univ, Grad Sch Med, Dept Cardiol, Nagoya, Aichi, Japan

[17] Fukushima Med Univ, Dept Cardiovasc Med, Fukushima, Japan

[18] Kanazawa Univ, Grad Sch Med Sci, Dept Cardiol, Kanazawa, Japan

[19] Nagasaki Univ, Grad Sch Biomed Sci, Dept Cardiovasc Med, Nagasaki, Japan

[20] Kitasato Univ, Dept Cardiovasc Med, Sagamihara, Kanagawa, Japan

[21] Jichi Med Univ, Saitama Med Ctr, Dept Cardiol, Saitama, Japan

[22] Osaka Metropolitan Univ, Grad Sch Med, Dept Med Stat, Osaka, Japan

[23] Osaka Metropolitan Univ Hosp, Ctr Clin Res & Innovat, Dept Clin Res Support, Data Management Grp, Osaka, Japan

[24] Niigata Univ, Med & Dent Hosp, Clin & Translat Res Ctr, Niigata, Japan

[25] Saga Univ, Dept Cardiovasc Med, Saga, Japan

[26] Japan Agcy Med Res & Dev, Japan Agcy Med Res & Dev Core Res Evolutionary Med, Tokyo, Japan

来源：

CARDIOVASCULAR DIABETOLOGY | 2024年 / 23卷 / 01期

关键词：

Ventricular arrhythmia; Sodium-glucose cotransporter 2; Type; 2; diabetes; Empagliflozin; SUDDEN CARDIAC DEATH; RISK; METAANALYSIS; ASSOCIATION; INHIBITORS; MORTALITY;

D O I：

10.1186/s12933-024-02309-9

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death with type 2 diabetes; however, their effect on arrhythmias is unclear. The purpose of this study was to investigate the effects of empagliflozin on ventricular arrhythmias in patients with type 2 diabetes. Methods A total of 150 patients with type 2 diabetes who were treated with an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator (ICD/CRT-D) were randomized to once-daily empagliflozin or placebo for 24 weeks. The primary endpoint was the change in the number of ventricular arrhythmias from the 24 weeks before to the 24 weeks during treatment. Secondary endpoints included the change in the number of appropriate device discharges and other values. Results In the empagliflozin group, the number of ventricular arrhythmias recorded by ICD/CRT-D decreased by 1.69 during treatment compared to before treatment, while in the placebo group, the number increased by 1.79. The coefficient for the between-group difference was - 1.07 (95% confidence interval [CI] - 1.29 to - 0.86; P < 0.001). The change in the number of appropriate device discharges during and before treatment was 0.06 in the empagliflozin group and 0.27 in the placebo group, with no significant difference between the groups (P = 0.204). Empagliflozin was associated with an increase in blood ketones and hematocrit and a decrease in blood brain natriuretic peptide and body weight. ConclusionsIn patients with type 2 diabetes treated with ICD/CRT-D, empagliflozin reduces the number of ventricular arrhythmias compared with placebo.Trial registration jRCTs031180120. Conclusions In patients with type 2 diabetes treated with ICD/CRT-D, empagliflozin reduces the number of ventricular arrhythmias compared with placebo.

引用

页数：11

共 32 条

[1] Hypoglycaemia, cardiovascular disease, and mortality in diabetes: epidemiology, pathogenesis, and management [J].

Amiel, Stephanie A. ;

Frier, Brian M. ;

Heller, Simon R. ;

McCrimmon, Rory J. ;

Khunti, Kamlesh ;

Aschner, Pablo ;

Childs, Belinda ;

Cryer, Philip E. ;

Gonder-Frederick, Linda ;

Seaquist, Elizabeth R. ;

de Galan, Bastiaan E. ;

Jones, Timothy ;

Zoungas, Sophia ;

Leiter, Lawrence A. ;

Luo, Yingying ;

Pedersen-Bjergaard, Ulrik .

LANCET DIABETES & ENDOCRINOLOGY, 2019, 7 (05) :385-396

[2] Empagliflozin in Heart Failure with a Preserved Ejection Fraction [J].

Anker, Stefan D. ;

Butler, Javed ;

Filippatos, Gerasimos ;

Ferreira, Joao P. ;

Bocchi, Edimar ;

Boehm, Michael ;

Brunner-La Rocca, Hans-Peter ;

Choi, Dong-Ju ;

Chopra, Vijay ;

Chuquiure-Valenzuela, Eduardo ;

Giannetti, Nadia ;

Gomez-Mesa, Juan Esteban ;

Janssens, Stefan ;

Januzzi, James L. ;

Gonzalez-Juanatey, Jose R. ;

Merkely, Bela ;

Nicholls, Stephen J. ;

Perrone, Sergio V. ;

Pina, Ileana L. ;

Ponikowski, Piotr ;

Senni, Michele ;

Sim, David ;

Spinar, Jindrich ;

Squire, Iain ;

Taddei, Stefano ;

Tsutsui, Hiroyuki ;

Verma, Subodh ;

Vinereanu, Dragos ;

Zhang, Jian ;

Carson, Peter ;

Lam, Carolyn Su Ping ;

Marx, Nikolaus ;

Zeller, Cordula ;

Sattar, Naveed ;

Jamal, Waheed ;

Schnaidt, Sven ;

Schnee, Janet M. ;

Brueckmann, Martina ;

Pocock, Stuart J. ;

Zannad, Faiez ;

Packer, Milton .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 385 (16) :1451-1461

[3]

Araki E, 2020, DIABETOL INT, V11, P165, DOI [10.1111/jdi.13306, 10.1007/s13340-020-00439-5]

[4] The association between SGLT2 inhibitors and new-onset arrhythmias: a nationwide population-based longitudinal cohort study [J].

Chen, Hung-Yi ;

Huang, Jing-Yang ;

Siao, Wun-Zhih ;

Jong, Gwo-Ping .

CARDIOVASCULAR DIABETOLOGY, 2020, 19 (01)

[5] Risk of Cardiac Arrhythmias During Hypoglycemia in Patients With Type 2 Diabetes and Cardiovascular Risk [J].

Chow, Elaine ;

Bernjak, Alan ;

Williams, Scott ;

Fawdry, Robert A. ;

Hibbert, Steve ;

Freeman, Jenny ;

Sheridan, Paul J. ;

Heller, Simon R. .

DIABETES, 2014, 63 (05) :1738-1747

[6] SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control [J].

Cowie, Martin R. ;

Fisher, Miles .

NATURE REVIEWS CARDIOLOGY, 2020, 17 (12) :761-772

[7] Effect of dapagliflozin on ventricular arrhythmias, resuscitated cardiac arrest, or sudden death in DAPA-HF [J].

Curtain, James P. ;

Docherty, Kieran F. ;

Jhund, Pardeep S. ;

Petrie, Mark C. ;

Inzucchi, Silvio E. ;

Kober, Lars ;

Kosiborod, Mikhail N. ;

Martinez, Felipe A. ;

Ponikowski, Piotr ;

Sabatine, Marc S. ;

Bengtsson, Olof ;

Langkilde, Anna Maria ;

Sjostrand, Mikaela ;

Solomon, Scott D. ;

McMurray, John J., V .

EUROPEAN HEART JOURNAL, 2021, 42 (36) :3727-3738

[8] Association of SGLT2 inhibitors with arrhythmias and sudden cardiac death in patients with type 2 diabetes or heart failure: A meta-analysis of 34 randomized controlled trials [J].

Fernandes, Gilson C. ;

Fernandes, Amanda ;

Cardoso, Rhanderson ;

Penalver, Jorge ;

Knijnik, Leonardo ;

Mitrani, Raul D. ;

Myerburg, Robert J. ;

Goldberger, Jeffrey J. .

HEART RHYTHM, 2021, 18 (07) :1098-1105

[9] Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPA-ICD) in Patients with Type 2 Diabetes (T2DM): Rationale and Design [J].

Fujiki, Shinya ;

Iijima, Kenichi ;

Okabe, Masaaki ;

Niwano, Shinichi ;

Tsujita, Kenichi ;

Naito, Shigeto ;

Ando, Kenji ;

Kusano, Kengo ;

Kato, Ritsushi ;

Nitta, Junichi ;

Miura, Tetsuji ;

Mitsuhashi, Takeshi ;

Kario, Kazuomi ;

Kondo, Yusuke ;

Ieda, Masaki ;

Hagiwara, Nobuhisa ;

Murohara, Toyoaki ;

Takahashi, Kazuyoshi ;

Tomita, Hirofumi ;

Takeishi, Yasuchika ;

Anzai, Toshihisa ;

Shimizu, Wataru ;

Watanabe, Masafumi ;

Morino, Yoshihiro ;

Kato, Takeshi ;

Tada, Hiroshi ;

Nakagawa, Yoshihisa ;

Yano, Masafumi ;

Maemura, Koji ;

Kimura, Takeshi ;

Yoshida, Hisako ;

Ota, Keiko ;

Tanaka, Takahiro ;

Kitamura, Nobutaka ;

Node, Koichi ;

Aizawa, Yoshifusa ;

Shimizu, Ippei ;

Izumi, Daisuke ;

Ozaki, Kazuyuki ;

Minamino, Tohru .

DIABETES THERAPY, 2020, 11 (11) :2739-2755

[10] Sodium-glucose cotransporter 2 inhibitors (SGLT2i) and cardiac arrhythmias: a systematic review and meta-analysis [J].

Li, Hang-Long ;

Lip, Gregory-Y H. ;

Feng, Qi ;

Fei, Yue ;

Tse, Yi-Kei ;

Wu, Mei-Zhen ;

Ren, Qing-Wen ;

Tse, Hung-Fat ;

Cheung, Bernard-M Y. ;

Yiu, Kai-Hang .

CARDIOVASCULAR DIABETOLOGY, 2021, 20 (01)

← 1 2 3 4 →