Empagliflozin and Cardiovascular Outcomes in Asian Patients With Type 2 Diabetes and Established Cardiovascular Disease - Results From EMPA-REG OUTCOME®
Empagliflozin and Cardiovascular Outcomes in Asian Patients With Type 2 Diabetes and Established Cardiovascular Disease - Results From EMPA-REG OUTCOME®
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DOI：
10.1253/circj.cj-16-1148
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发表时间：
2017-02-01
影响因子：
3.3
通讯作者：
Malano, J.
中科院分区：
文献类型：
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作者：
Kaku, Kohei;Lee, Jisoo;Malano, J.
背景资料：在EMPA-REG OUTCOME（R）试验中，恩格列净加用标准治疗降低了3点主要心血管不良（CV）事件的风险（3点MACE：CV死亡、非致死性心肌梗死或非致死性卒中的复合终点）减少14%，CV死亡减少38%，因心力衰竭住院治疗减少35%，2型糖尿病（T2 DM）和确诊CV疾病患者的全因死亡率降低32%。我们调查了恩格列净在亚洲race.Methods和结果的患者的影响：患者随机接受恩格列净10毫克，恩格列净25毫克，或安慰剂。在接受治疗的7，020例患者中，1，517例（21.6%）为亚洲人种。亚洲患者3点MACE的减少与总体人群一致：79/1，006例患者发生3点MACE（7.9%）对比58/511例患者（11.4%），安慰剂组（风险比：0.68 [95%置信区间：0.48-0.95]，治疗与人种相互作用的P值（亚裔、白色、黑人/非裔美国人）：0.0872）。在亚洲患者中，恩格列净对MACE组分、全因死亡率和心力衰竭结局的影响与总体人群一致（人种相互作用的P值>0.05）。恩格列净在亚洲患者中的不良事件特征与总体试验人群相似。结论：恩格列净在亚洲T2 DM和确诊CV疾病患者中降低CV结局和死亡率的风险与总体试验人群一致。
Background: In the EMPA-REG OUTCOME (R) trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular (CV) events (3-point MACE: composite of CV death, non-fatal myocardial infarction, or non-fatal stroke) by 14%, CV death by 38%, hospitalization for heart failure by 35%, and all-cause mortality by 32% in patients with type 2 diabetes (T2DM) and established CV disease. We investigated the effects of empagliflozin in patients of Asian race.Methods and Results: Patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Of 7,020 patients treated, 1,517 (21.6%) were of Asian race. The reduction in 3-point MACE in Asian patients was consistent with the overall population: 3-point MACE occurred in 79/1,006 patients (7.9%) in the pooled empagliflozin group vs. 58/511 patients (11.4%) in the placebo group (hazard ratio: 0.68 [95% confidence interval: 0.48-0.95], P-value for treatment by race interaction (Asian, White, Black/African-American): 0.0872). The effects of empagliflozin on the components of MACE, all-cause mortality, and heart failure outcomes in Asian patients were consistent with the overall population (P-values for interaction by race >0.05). The adverse event profile of empagliflozin in Asian patients was similar to the overall trial population.Conclusions: Reductions in the risk of CV outcomes and mortality with empagliflozin in Asian patients with T2DM and established CV disease were consistent with the overall trial population.