PDF(Pubmed)
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.
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.
摘要：
背景：钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂可降低2型糖尿病患者因心力衰竭和心血管死亡而住院的风险；然而，它们对心律失常的影响尚不清楚。目的探讨依帕列净对2型糖尿病患者室性心律失常的影响。
方法：共150例2型糖尿病患者接受植入式心律转复除颤器或心脏再同步除颤器（ICD/CRT-D）治疗，随机接受每天一次的依帕列净或安慰剂治疗，为期24周。主要终点是从治疗前24周到治疗期间24周室性心律失常数量的变化。次要终点包括适当设备放电次数的变化和其他值。
结果：在empagliflozin组中，与治疗前相比，ICD/CRT-D记录的室性心律失常数量在治疗期间减少了1.69，而在安慰剂组，增加了1.79。组间差异系数为-1.07（95%置信区间[CI]-1.29至-0.86；P<0.001）。在治疗期间和治疗前，依帕列净组的适当装置放电次数的变化为0.06，安慰剂组为0.27，组间差异无统计学意义(P=0.204)。Empagliflozin与血酮和血细胞比容的增加以及血脑利钠肽和体重的减少有关。
结论：在接受ICD/CRT-D治疗的2型糖尿病患者中，与安慰剂相比,empagliflozin减少了室性心律失常的数量.试用注册jRCTs031180120。
方法：共150例2型糖尿病患者接受植入式心律转复除颤器或心脏再同步除颤器（ICD/CRT-D）治疗，随机接受每天一次的依帕列净或安慰剂治疗，为期24周。主要终点是从治疗前24周到治疗期间24周室性心律失常数量的变化。次要终点包括适当设备放电次数的变化和其他值。
结果：在empagliflozin组中，与治疗前相比，ICD/CRT-D记录的室性心律失常数量在治疗期间减少了1.69，而在安慰剂组，增加了1.79。组间差异系数为-1.07（95%置信区间[CI]-1.29至-0.86；P<0.001）。在治疗期间和治疗前，依帕列净组的适当装置放电次数的变化为0.06，安慰剂组为0.27，组间差异无统计学意义(P=0.204)。Empagliflozin与血酮和血细胞比容的增加以及血脑利钠肽和体重的减少有关。
结论：在接受ICD/CRT-D治疗的2型糖尿病患者中，与安慰剂相比,empagliflozin减少了室性心律失常的数量.试用注册jRCTs031180120。
