芬在心力衰竭中与轻微减少或保留喷射分数的治疗
Scott D Solomon1, John J V McMurray1, Muthiah Vaduganathan1
1From the Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (S.D.S., M.V., B.C., A.S.D.); British Heart Foundation Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow (J.J.V.M., P.S.J., A.D.H., M.C.P.), and Bayer, Reading (J.L.-F.) - both in the United Kingdom; National Heart Centre Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); University of Michigan School of Medicine, Ann Arbor (B.P.); University of Milano-Bicocca and Papa Giovanni XXIII Hospital, Bergamo (M. Senni), and the Department of Cardiology, University of Brescia, and ASST "Spedali Civili" Hospital, Brescia (S.N.) - all in Italy; Northwestern University Feinberg School of Medicine, Chicago (S.J.S.); University Medical Center Groningen, Groningen (A.A.V.), the Department of Cardiology, Hospital Group Twente, Almelo (G.C.M.L.), and Bayer, Hoofddorp (I.G.) - all in the Netherlands; Université de Lorraine, INSERM Clinical Investigation Centre, Centre Hospitalier Universitaire, Nancy, France (F.Z.); University of Malaya, Kuala Lumpur, Malaysia (I.Z.A.); Centro de Estudios Clínicos de Querétaro, Santiago de Querétaro (M.A.A.-G.), and Hospital Cardiologico Aguascalientes, Aguascalientes (G.L.-E.) - both in Mexico; Cardiology Research Department, Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, Australia (J.J.A.); the Department of Cardiology and Angiology, Hannover Medical School, Hannover (J.B.), and Bayer, Wuppertal (P.K.) - both in Germany; Beijing Anzhen Hospital, Capital Medical University, Beijing (M.C.-S.); General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital, and National Yang Ming Chiao Tung University, Taipei, Taiwan (C.-E.C.); Emergency Institute for Cardiovascular Diseases "Prof. Dr. C.C. Iliescu," University of Medicine Carol Davila, Bucharest, Romania (O.C.); Clinical Cardiology, Heart Failure and Research, Max Super Specialty Hospital, New Delhi, India (V.C.); the Department of Cardiology, Bellvitge University Hospital, and Bellvitge Biomedical Research Institute, Centro de Investigación Biomédica En Red Enfermedades Cardiovasculares, University of Barcelona, L'Hospitalet de Llobregat, Barcelona (J.C.-C.); the Department of Cardiology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens (G.F.); the Department of Internal Medicine, Hospital São Francisco Xavier, and NOVA Medical School, Universidade Nova de Lisboa, Lisbon, Portugal (C.F.); the Department of Coronary Disease and Heart Failure, Jagiellonian University Medical College, Krakow, Poland (G.G.); the Heart Institute, Kaplan Medical Center, Rehovot, and Hebrew University, Jerusalem - both in Israel (S.G.); the Faculty of Medicine, Comenius University, Bratislava, Slovakia (E.G.); the Division of Cardiology, Severance Hospital, and Yonsei University Health System, Seoul, South Korea (S.K.); the Department of Noninvasive Cardiology, National Cardiology Hospital, Sofia, Bulgaria (T.K.); St. Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); Latvian Center of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia (G.L.); Li Ka Shing Institute of Health Sciences, the Chinese University of Hong Kong, Hong Kong (A.P.-W.L.); University Clinic of Lomonosov Moscow State University, Moscow (V. Mareev); Universidad Nacional de Córdoba, Córdoba, Argentina (F.A.M.); the Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (V. Melenovský); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Centro Cardiovascular Colombiano, Clínica Santa María, Medellin, Colombia (C.I.S.); Cardiovascular Division, Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.), and Bayer, São Paulo (F.A.) - both in Brazil; Kawaguchi Cardiovascular and Respiratory Hospital, Saitama, Japan (N.S.); the Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, Denmark (M. Schou); the Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore (K.S.); Christchurch Heart Institute, Department of Medicine, University of Otago, Christchurch, New Zealand (R.T.); Women's College Hospital and Peter Munk Cardiac Centre, Toronto General Hospital (J.A.U.), University of Toronto (J.A.U., S.V.), and the Division of Cardiac Surgery, St. Michael's Hospital (S.V.), Toronto, and the Section of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg (S.Z.) - both in Canada; Heart Centre, Turku University Hospital, Turku, Finland (H.U.); the Department of Medicine, University of Minnesota, and Minneapolis VA Health Care System, Minneapolis (O.V.); the Department of Internal Medicine, Division of Cardiology, Medical University of Graz, Graz, Austria (D.L.); National Scientific Center, Strazhesko Institute of Cardiology, National Academy of Medical Sciences, Kyiv, Ukraine (L.V.); Dokuz Eylul University Medical Faculty, Cardiology Department, Izmir, Turkey (M.B.Y.); and Bayer, Whippany, NJ (P.V.).
芬瑞能显著降低了心力衰竭事件的恶化和心血管死亡,在患者中轻微减少或保留了射出分数. 这种非类固醇矿物质皮质类受体抗剂为这种心力衰竭患者群体提供了新的治疗选择.
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:
- 类固醇矿物质皮质体受体对抗剂 (MRAs) 是已确立的心力衰竭治疗方法,减少排气分数 (HFrEF).
- 在心力衰竭患者中,MRAs的疗效与轻度减少的喷射分数 (HFmrEF) 或保存的喷射分数 (HFpEF) 仍然不确定.
- 需要关于非类固醇MRAs,如finerenone,在HFmrEF和HFpEF种群中的有效性和安全性的数据.
研究的目的:
- 为了评估与安慰剂相比,在患有心力衰竭和左心室喷射率 (LVEF) 40%或以上的患者中,费内伦的疗效和安全性.
- 为了评估费内伦对恶化心力衰竭事件和心血管死亡的复合结果的影响.
主要方法:
- 进行了一项国际双盲随机对照试验 (FINEARTS-HF).
- 患有LVEF≥40%的患者被随机分配1:1接受finerenone (每天高达40毫克) 或安慰剂,同时接受标准治疗.
- 主要结局是整体恶化的心力衰竭事件和心血管死亡的组合,并对单个组件和安全性的二次评估.
主要成果:
- 在32个月的中位数随访期间,与安慰剂相比,finerenone显著减少了16%的初级复合结果 (率比,0.84;P=0.007).
- 费内伦组中恶化的心力衰竭事件明显较低 (率比,0.82;P=0.006).
- 心血管死亡率在各组之间是相似的,但finerenone与高胆固醇血量增加和低胆固醇血量减少有关.
结论:
- 在患有HFmrEF和HFpEF的患者中,芬瑞在降低心力衰竭事件恶化和心血管死亡的复合效果方面表现出显著的有效性.
- 这些发现支持芬二作为心力衰竭和LVEF≥40%的患者的治疗选择.
- 安全性概况包括高血症的风险增加,需要仔细监测.
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