Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure

达帕格列嗪 医学 危险系数 心力衰竭 心肌梗塞 内科学 安慰剂 心脏病学 心房颤动 糖尿病 置信区间 2型糖尿病 内分泌学 替代医学 病理
作者
Stefan James,David Erlinge,Robert F. Storey,Darren K. McGuire,Mark de Belder,Niclas Eriksson,Kasper Andersen,David Austin,Gabriel Arefalk,David Carrick,Robin Hofmann,Stephen P. Hoole,Daniel A. Jones,Kelvin Lee,Hans Tygesen,Peter A. Johansson,Anna Maria Langkilde,Wilhelm Ridderstråle,Ehsan Parvaresh Rizi,John Deanfield,Jonas Oldgren
出处
期刊:NEJM evidence [New England Journal of Medicine]
卷期号:3 (2) 被引量:105
标识
DOI:10.1056/evidoa2300286
摘要

BACKGROUND: In patients with acute myocardial infarction (MI), therapies that could further reduce the risk of adverse cardiovascular and metabolic outcomes are needed. METHODS: In this international registry-based, randomized, double-blind trial, patients without prior diabetes or chronic heart failure, presenting with acute MI and impaired left ventricular systolic function, were randomly assigned 10 mg of dapagliflozin or placebo, given once daily. The primary outcome was the hierarchical composite of death, hospitalization for heart failure, nonfatal MI, atrial fibrillation/flutter, type 2 diabetes mellitus, New York Heart Association Functional Classification at the last visit, and body weight decrease of 5% or greater at the last visit using the win ratio analysis method. The key secondary outcome was the same hierarchical composite excluding the body weight component. RESULTS: We enrolled 4017 patients of whom 2019 were assigned to dapagliflozin and 1998 to placebo. The analysis of the primary hierarchical composite outcome resulted in significantly more wins for dapagliflozin than for placebo (win ratio, 1.34; 95% confidence interval [CI], 1.20 to 1.50; P<0.001). The win ratio outcome, which was adopted in a change of analysis during trial performance because of low event accrual, was mainly driven by the added cardiometabolic outcomes. The composite of time to cardiovascular death/hospitalization for heart failure occurred in 50/2019 (2.5%) patients assigned to dapagliflozin and 52/1998 (2.6%) patients assigned to placebo (hazard ratio, 0.95; 95% CI, 0.64 to 1.40). The rates of other cardiovascular events were low, with differences between the groups not reaching nominal statistical significance. No safety concerns were identified. CONCLUSIONS: In patients with acute MI as noted above, after approximately 1 year of treatment with dapagliflozin there were significant benefits with regard to improvement in cardiometabolic outcomes but no impact on the composite of cardiovascular death or hospitalization for heart failure compared with placebo. (Funded by AstraZeneca; ClinicalTrial.gov number, NCT04564742.)
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