Empagliflozin in Heart Failure with a Preserved Ejection Fraction

被引:3110
作者
Anker, Stefan D. [1 ]
Butler, Javed [7 ]
Filippatos, Gerasimos [8 ]
Ferreira, Joao P. [9 ,10 ,12 ]
Bocchi, Edimar [13 ]
Boehm, Michael [2 ]
Brunner-La Rocca, Hans-Peter [14 ,15 ]
Choi, Dong-Ju [16 ]
Chopra, Vijay [17 ]
Chuquiure-Valenzuela, Eduardo [18 ]
Giannetti, Nadia [19 ]
Gomez-Mesa, Juan Esteban [21 ]
Janssens, Stefan
Januzzi, James L. [23 ,24 ]
Gonzalez-Juanatey, Jose R. [25 ]
Merkely, Bela
Nicholls, Stephen J. [27 ]
Perrone, Sergio V. [28 ,29 ]
Pina, Ileana L. [30 ]
Ponikowski, Piotr [31 ]
Senni, Michele [32 ]
Sim, David [34 ]
Spinar, Jindrich [22 ,35 ,36 ]
Squire, Iain [37 ]
Taddei, Stefano [33 ]
Tsutsui, Hiroyuki [41 ]
Verma, Subodh [20 ]
Vinereanu, Dragos [42 ,43 ]
Zhang, Jian [44 ,45 ]
Carson, Peter [46 ]
Lam, Carolyn Su Ping [47 ]
Marx, Nikolaus [3 ]
Zeller, Cordula [4 ]
Sattar, Naveed [38 ]
Jamal, Waheed [5 ]
Schnaidt, Sven [4 ]
Schnee, Janet M. [48 ]
Brueckmann, Martina [5 ,6 ,26 ]
Pocock, Stuart J. [39 ]
Zannad, Faiez [11 ]
Packer, Milton [40 ,49 ]
机构
[1] Charite Univ Med Berlin, Berlin, Germany
[2] Univ Klinikum Saarlandes, Homberg, Germany
[3] Rhein Westfal TH Aachen, Aachen, Germany
[4] Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany
[5] Boehringer Ingelheim Int, Ingelheim, Germany
[6] Heidelberg Univ, Fac Med Mannheim, Mannheim, Germany
[7] Univ Mississippi, Med Ctr, Jackson, MS 39216 USA
[8] Natl & Kapodistrian Univ Athens, Sch Med, Athens, Greece
[9] Univ Lorraine, INSERM, Ctr Invest Clin Plurithemat 1433, Nancy, France
[10] CHRU, INSERM, Unite 1116, FCRIN INI CRCT Cardiovasc & Renal Clin Trialists, Nancy, France
[11] Univ Lorraine, CHRU, INSERM INI CRCT, Nancy, France
[12] Univ Porto, Fac Med, Dept Surg & Physiol, Cardiovasc Res & Dev Ctr, Porto, Portugal
[13] Univ Sao Paulo, Fac Med, Hosp Clin HCFMUSP, Unidade Insuficiencia Cardiaca,Inst Coracao, Sao Paulo, Brazil
[14] Maastricht Univ, Med Ctr, Maastricht, Netherlands
[15] Sch Cardiovasc Dis CARIM, Maastricht, Netherlands
[16] Seoul Natl Univ, Bundang Hosp, Dept Med, Seoul, South Korea
[17] Max Superspecial Hosp, New Delhi, India
[18] Natl Inst Cardiol, Mexico City, DF, Mexico
[19] McGill Univ, Ctr Hlth, Montreal, PQ, Canada
[20] Univ Toronto, St Michaels Hosp, Toronto, ON, Canada
[21] Univ ICESI, Fdn Valle Lili, Serv Cardiol, Cali, Colombia
[22] Univ Hosp Leuven, Dept Cardiovasc Dis, Leuven, Belgium
[23] Massachusetts Gen Hosp, Boston, MA 02114 USA
[24] Baim Inst Clin Res, Boston, MA USA
[25] Univ Hosp, Santiago De Compostela, Spain
[26] Semmelweiss Univ, Heart & Vasc Ctr, Budapest, Hungary
[27] Monash Univ, Victorian Heart Inst, Melbourne, Vic, Australia
[28] Argentine Catholic Univ, Buenos Aires, DF, Argentina
[29] FLENI & IADT Inst, Med Advisor Heart Failure Pulm Hypertens & Intrat, Buenos Aires, DF, Argentina
[30] Cent Michigan Univ, Mt Pleasant, MI 48859 USA
[31] Wroclaw Med Univ, Wroclaw, Poland
[32] Papa Giovanni XXIII Hosp, Div Cardiol, Cardiovascu Dept, Bergamo, Italy
[33] Univ Pisa, Pisa, Italy
[34] Natl Heart Ctr Singapore, Singapore, Singapore
[35] St Ann Univ Hosp, Internal Cardiol Dept, Brno, Czech Republic
[36] Masaryk Univ, Brno, Czech Republic
[37] Univ Leicester, Glenfield Gen Hosp, Leicester, Leics, England
[38] Univ Glasgow, Glasgow, Lanark, Scotland
[39] London Sch Hyg & Trop Med, London, England
[40] Imperial Coll, London, England
[41] Kyushu Univ, Fukuoka, Japan
[42] Carol Davila Univ, Univ Med & Pharm, Bucharest, Romania
[43] Emergency Hosp, Bucharest, Romania
[44] Chinese Acad Med Sci, Fuwai Hosp, Heart Failure Ctr, Beijing, Peoples R China
[45] Peking Union Med Coll, Beijing, Peoples R China
[46] Vet Affairs Med Ctr, 50 Irving St NW, Washington, DC 20422 USA
[47] Duke Natl Univ Singapore, Natl Heart Ctr Singapore, Singapore, Singapore
[48] Boehringer Ingelheim Pharmaceut, Ridgefield, CT USA
[49] Baylor Heart & Vasc Inst, Dallas, TX USA
关键词
SPIRONOLACTONE;
D O I
10.1056/NEJMoa2107038
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, but their effects in patients with heart failure and a preserved ejection fraction are uncertain. METHODS In this double-blind trial, we randomly assigned 5988 patients with class II-IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. RESULTS Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P<0.001). This effect was mainly related to a lower risk of hospitalization for heart failure in the empagliflozin group. The effects of empagliflozin appeared consistent in patients with or without diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated genital and urinary tract infections and hypotension were reported more frequently with empagliflozin. CONCLUSIONS Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes.
引用
收藏
页码:1451 / 1461
页数:11
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