1. Effect of empagliflozin on ventricular arrhythmias in patients with type 2 diabetes treated with an implantable cardioverter-defibrillator: the EMPA-ICD trial.
- Author
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Fujiki S, Iijima K, Nakagawa Y, Takahashi K, Okabe M, Kusano K, Owada S, Kondo Y, Tsujita K, Shimizu W, Tomita H, Watanabe M, Shoda M, Watanabe M, Tokano T, Murohara T, Kaneshiro T, Kato T, Hayashi H, Maemura K, Niwano S, Umemoto T, Yoshida H, Ota K, Tanaka T, Kitamura N, Node K, and Minamino T
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Treatment Outcome, Time Factors, Double-Blind Method, Japan, Cardiac Resynchronization Therapy adverse effects, Blood Glucose metabolism, Blood Glucose drug effects, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 drug therapy, Glucosides therapeutic use, Glucosides adverse effects, Benzhydryl Compounds therapeutic use, Benzhydryl Compounds adverse effects, Sodium-Glucose Transporter 2 Inhibitors therapeutic use, Sodium-Glucose Transporter 2 Inhibitors adverse effects, Defibrillators, Implantable, Electric Countershock instrumentation, Electric Countershock adverse effects
- Abstract
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., Conclusions: In patients with type 2 diabetes treated with ICD/CRT-D, empagliflozin reduces the number of ventricular arrhythmias compared with placebo. Trial registration jRCTs031180120., (© 2024. The Author(s).)
- Published
- 2024
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