恩格列净治疗急性心肌梗死。
Empagliflozin after Acute Myocardial Infarction.
机构信息
From Baylor Scott and White Research Institute, Dallas (J. Butler); the Department of Medicine, University of Mississippi, Jackson (J. Butler); the Division of Cardiology, Department of Medicine, Duke University Medical Center (W.S.J., J.H., A.F.H.), and the Duke Clinical Research Institute (R.D.L.) - both in Durham, NC; Women's College Hospital (J.A.U.), the Peter Munk Cardiac Centre, University Health Network, University of Toronto (J.A.U., S.G.G.), and the Division of Cardiology, Department of Medicine, St. Michael's Hospital, Unity Health Toronto (S.G.G.), Toronto, the Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Section of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg (S.Z.) - all in Canada; the Department of Cardiology, German Heart Center Charité, Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim Pharma (M.M., I.Z.) and Boehringer Ingelheim International (T.G., W.J., M.B., M. Sumin), Ingelheim, the Department of Cardiology and Angiology, Hannover Medical School, Hannover (J. Bauersachs), and the First Department of Medicine, Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M.B.) - all in Germany; the School of Cardiovascular and Medical Sciences, British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (M.C.P.); the Heart Institute, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem (O.A.); Instituto de Neurología (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); the Heart Institute, Hospital Universitari Germans Trias i Pujol, and the Department of Medicine, Universitat Autònomoa de Barcelona, Barcelona (A.B.-G.), and Son Espases University Hospital, Health Research Institute of the Balearic Islands, University of the Balearic Islands, Palma de Mallorca (X.R.) - all in Spain; the Department of Cardiology, First Medical Center of Chinese People's Liberation Army General Hospital, Beijing (Y.C.), and the Department of Cardiology, Zhongshan Hospital, Fudan University, and the Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai (J.G.) - both in China; the Department of Cardiology, Medanta, Gurgaon, India (V.K.C.); the Faculty of Medicine and Health, University of Sydney, Sydney (G.F.); the Department of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (N.G.); Tokai University School of Medicine, Isehara, Japan (S.G.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.L.J.); Chonnam National University Hospital and Medical School, Gwangju, South Korea (M.H.J.); Volgograd State Medical University, Volgograd, Russia (Y.L.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); the Division of Cardiovascular Medicine, Department of Medicine, State University of New York at Stony Brook, Stony Brook (P.B.P.), and Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York (D.L.B.) - both in New York; the Ukrainian Institute of Cardiology M.D. Strazhesko, National Academy of Medical Sciences, Kyiv, Ukraine (A.P.); Collegium Medicum-Faculty of Medicine, WSB University, Dąbrowa Górnicza (T.G.), and the Institute for Heart Diseases Medical University (P.P.) and Jan Mikulicz-Radecki University Clinical Hospital (J.S.), Wrocław - all in Poland; the Department of Cardiology, Herlev and Gentofte University Hospital, Copenhagen (M. Schou); the Department of Cardiovascular Diseases, University Clinical Center Belgrade, Belgrade, Serbia (D.S.); Université Paris-Cité, French Alliance for Cardiovascular Trials, INSERM Unité 1148, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris (P.G.S.); the Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (P.M.); and University and Emergency Hospital of Bucharest, Bucharest, Romania (D.V.).
出版信息
N Engl J Med. 2024 Apr 25;390(16):1455-1466. doi: 10.1056/NEJMoa2314051. Epub 2024 Apr 6.
BACKGROUND
Empagliflozin improves cardiovascular outcomes in patients with heart failure, patients with type 2 diabetes who are at high cardiovascular risk, and patients with chronic kidney disease. The safety and efficacy of empagliflozin in patients who have had acute myocardial infarction are unknown.
METHODS
In this event-driven, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, patients who had been hospitalized for acute myocardial infarction and were at risk for heart failure to receive empagliflozin at a dose of 10 mg daily or placebo in addition to standard care within 14 days after admission. The primary end point was a composite of hospitalization for heart failure or death from any cause as assessed in a time-to-first-event analysis.
RESULTS
A total of 3260 patients were assigned to receive empagliflozin and 3262 to receive placebo. During a median follow-up of 17.9 months, a first hospitalization for heart failure or death from any cause occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years (hazard ratio, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P = 0.21). With respect to the individual components of the primary end point, a first hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and in 153 patients (4.7%) in the placebo group (hazard ratio, 0.77; 95% CI, 0.60 to 0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (hazard ratio, 0.96; 95% CI, 0.78 to 1.19). Adverse events were consistent with the known safety profile of empagliflozin and were similar in the two trial groups.
CONCLUSIONS
Among patients at increased risk for heart failure after acute myocardial infarction, treatment with empagliflozin did not lead to a significantly lower risk of a first hospitalization for heart failure or death from any cause than placebo. (Funded by Boehringer Ingelheim and Eli Lilly; EMPACT-MI ClinicalTrials.gov number, NCT04509674.).
背景
恩格列净可改善心力衰竭患者、伴有高心血管风险的 2 型糖尿病患者和慢性肾脏病患者的心血管结局。在发生急性心肌梗死后的患者中，恩格列净的安全性和疗效尚不明确。
方法
在这项事件驱动、双盲、随机、安慰剂对照的试验中，我们按 1:1 的比例将因急性心肌梗死后有发生心力衰竭风险的患者分配，在入院后 14 天内，这些患者接受每日 10mg 恩格列净或安慰剂联合标准治疗。主要终点是首次发生心力衰竭住院或任何原因死亡的复合终点，采用时间至首次事件分析进行评估。
结果
共有 3260 名患者被分配接受恩格列净治疗，3262 名患者接受安慰剂治疗。中位随访 17.9 个月期间，恩格列净组有 267 名（8.2%）患者和安慰剂组有 298 名（9.1%）患者首次发生心力衰竭住院或任何原因死亡，相应的患者年发生率分别为 5.9 和 6.6 例事件（风险比，0.90；95%置信区间[CI]，0.76 至 1.06；P=0.21）。对于主要终点的各个组成部分，恩格列净组有 118 名（3.6%）患者和安慰剂组有 153 名（4.7%）患者首次发生心力衰竭住院（风险比，0.77；95%CI，0.60 至 0.98），有 169 名（5.2%）和 178 名（5.5%）患者死亡（风险比，0.96；95%CI，0.78 至 1.19）。不良事件与恩格列净已知的安全性特征一致，且在两组试验中相似。
结论
在急性心肌梗死后发生心力衰竭风险增加的患者中，与安慰剂相比，恩格列净治疗并未显著降低首次心力衰竭住院或任何原因死亡的风险。（由勃林格殷格翰和礼来资助；EMPACT-MI ClinicalTrials.gov 编号，NCT04509674。）
Zotero 插件