The effect of empagliflozin on the total burden of cardiovascular and hospitalization events in the Asian and non-Asian populations of the EMPA-REG OUTCOME trial of patients with type 2 diabetes and cardiovascular disease.

The effect of empagliflozin on the total burden of cardiovascular and hospitalization events in the Asian and non-Asian populations of the EMPA-REG OUTCOME trial of patients with type 2 diabetes and cardiovascular disease.
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DOI:
10.1111/dom.14626
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发表时间:
2022-04
影响因子:
5.8
通讯作者:
Lund, Soren S.
Lund, Soren S.
中科院分区:
医学2区
文献类型:
--
作者:
Kaku, Kohei;Wanner, Christoph;Anker, Stefan D.;Pocock, Stuart;Yasui, Atsutaka;Mattheus, Michaela;Lund, Soren S.

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钠-葡萄糖协同转运蛋白2抑制剂恩格列净降低了患有2型糖尿病(T2 D)和确诊动脉粥样硬化性心血管疾病(ASCVD)的EMPA-REG OUTCOME受试者的心血管总负担、死亡率和全因住院事件,包括首次和复发事件。我们研究了恩格列净对亚洲受试者心血管和住院事件总负担的影响。受试者随机接受恩格列净10 mg、25 mg或安慰剂加标准治疗。主要结局和关键次要结局分别为心血管死亡、非致命性心肌梗死和非致命性中风的复合结局以及主要结局加上不稳定型心绞痛住院治疗。使用负二项模型分析了汇总恩格列净与安慰剂对总(首次加复发)心血管和住院事件的影响,该模型保留了随机化并解释了多起事件的患者内相关性。我们事后分析了亚洲与非亚洲EMPA‐REG OUTCOME人群亚组。在1517例亚洲受试者中,与安慰剂相比,恩格列净使主要结局总事件的相对风险降低39%[率比(95%置信区间):0.61(0.43,0.89)],关键次要结局降低33% [0.67(0.48,0.93)],心血管死亡的复合终点(不包括致死性卒中)和因心力衰竭住院治疗减少43% [0.57(0.33,0.996)],全因住院治疗减少21% [0.79(0.65,0.97)]。恩格列净的效应在亚洲和非亚洲人群之间一致(治疗与亚组相互作用p > 0.05)。恩格列净降低了患有T2 D和确诊ASCVD的亚洲和非亚洲EMPA‐REG OUTCOME受试者的心血管和住院事件总负担,与总体试验人群一致。
The sodium‐glucose co‐transporter 2 inhibitor empagliflozin reduced the total burden of cardiovascular, mortality, and all‐cause hospitalization events, including first and recurrent events, in EMPA‐REG OUTCOME participants with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (ASCVD). We investigated the effect of empagliflozin on the total burden of cardiovascular and hospitalization events in Asian participants. Participants were randomized to empagliflozin 10 mg, 25 mg or placebo plus standard of care. The primary and key secondary outcomes were the composite of cardiovascular death, non‐fatal myocardial infarction, and non‐fatal stroke and the primary outcome plus hospitalization for unstable angina, respectively. The effect of pooled empagliflozin versus placebo on total (first plus recurrent) cardiovascular and hospitalization events was analysed using a negative binomial model that preserves randomization and accounts for within‐patient correlation of multiple events. We analysed Asian versus non‐Asian EMPA‐REG OUTCOME population subgroups post hoc. Among 1517 Asian participants, empagliflozin reduced the relative risk of total events of the primary outcome by 39% versus placebo [rate ratio (95% confidence interval): 0.61 (0.43, 0.89)], the key secondary outcome by 33% [0.67 (0.48, 0.93)], the composite of cardiovascular death (excluding fatal stroke) and hospitalization for heart failure by 43% [0.57 (0.33, 0.996)], and all‐cause hospitalization by 21% [0.79 (0.65, 0.97)]. The effects of empagliflozin were consistent between Asian and non‐Asian populations (treatment‐by‐subgroup interaction p > .05). Empagliflozin reduced the total burden of cardiovascular and hospitalization events in Asian and non‐Asian EMPA‐REG OUTCOME participants with T2D and established ASCVD, consistent with the overall trial population.
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