在急性心肌梗塞后使用Empagliflozin
Javed Butler1, W Schuyler Jones1, Jacob A Udell1
1From 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.).
在急性心肌梗塞后的患者中,empagliflozin并没有显著减少因心力衰竭或死亡而住院的病例. 这项研究研究了empagliflozin.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 已知empagliflozin对心力衰竭,2型糖尿病和慢性病患者有好处.
- 在急性心肌梗塞 (AMI) 患者中,empagliflozin的疗效和安全性仍未确立.
- 由于AMI住院的患者有患心力衰竭的风险.
研究的目的:
- 评估empagliflozin对急性心肌梗塞后患者心血管结果的影响.
- 评估高风险人群中住院治疗心力衰竭或全因死亡的综合终点.
主要方法:
- 这是一项双盲,随机,安慰剂对照试验 (EMPACT-MI),涉及6522名患者.
- 患者每天接受10毫克的empagliflozin或安慰剂,除了标准护理外,在AMI住院14天内接受治疗.
- 评估的主要终点是心力衰竭或因任何原因死亡的首次住院的时间.
主要成果:
- 综合主终点发生在empagliflozin组的8.2%和安慰剂组的9.1% (HR,0.90;95% CI,0.76到1.06).
- 观察到减少心力衰竭住院治疗的趋势 (HR,0.77;95% CI,0.60至0.98),但没有达到统计学意义.
- 不良事件在各组之间是可比的,并且与已知的empagliflozin安全概况一致.
结论:
- 在急性心肌梗塞后风险增加的患者中,empagliflozin没有显著降低心力衰竭或死亡住院的风险.
- 可能需要进一步的研究来确定可能受益于AMI后的empagliflozin的特定子组.
- 在这个患者群体中证实了empagliflozin的安全性.
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