Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction

被引:1342
作者
Solomon, S. D. [1 ]
McMurray, J. J., V [2 ]
Claggett, B. [1 ]
de Boer, R. A. [3 ]
DeMets, D. [5 ]
Hernandez, A. F. [6 ]
Inzucchi, S. E. [7 ]
Kosiborod, M. N. [8 ]
Lam, C. S. P. [3 ,9 ,10 ]
Martinez, F. [11 ]
Shah, S. J. [13 ]
Desai, A. S. [1 ]
Jhund, P. S. [2 ]
Belohlavek, J. [14 ]
Chiang, C-E [15 ,16 ,17 ]
Borleffs, C. J. W. [4 ]
Comin-Colet, J. [18 ,19 ]
Dobreanu, D. [20 ]
Drozdz, J. [21 ]
Fang, J. C. [22 ]
Alcocer-Gamba, M. A. [23 ]
Al Habeeb, W. [24 ]
Han, Y. [25 ]
Cabrera Honorio, J. W. [26 ]
Janssens, S. P. [27 ]
Katova, T. [28 ]
Kitakaze, M. [29 ]
Merkely, B. [30 ]
O'Meara, E. [31 ]
Saraiva, J. F. K. [33 ]
Tereshchenko, S. N. [34 ]
Thierer, J. [12 ]
Vaduganathan, M. [1 ]
Vardeny, O. [35 ]
Verma, S. [32 ]
Pham, V. N. [36 ]
Wilderang, U. [37 ]
Zaozerska, N. [37 ]
Bachus, E. [37 ]
Lindholm, D. [37 ]
Petersson, M. [37 ]
Langkilde, A. M. [37 ]
机构
[1] Harvard Med Sch, Brigham & Womens Hosp, Cardiovasc Div, Boston, MA 02115 USA
[2] Univ Glasgow, British Heart Fdn Glasgow Cardiovasc Res Ctr, Sch Cardiovasc & Metab Hlth, Glasgow, Lanark, Scotland
[3] Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands
[4] Haga Teaching Hosp, The Hague, Netherlands
[5] Univ Wisconsin, Madison, WI USA
[6] Duke Univ Med Ctr, Durham, NC USA
[7] Yale Sch Med, New Haven, CT USA
[8] Univ Missouri, St Lukes Mid Amer Heart Inst, Kansas City, MO 64110 USA
[9] Natl Heart Ctr Singapore, Singapore, Singapore
[10] Duke Natl Univ Singapore, Singapore, Singapore
[11] Natl Univ Cordoba, Cordoba, Argentina
[12] Ctr Educ Med & Invest Clin Norberto Quirno, Unidad Insuficiencia Cardiaca, Buenos Aires, DF, Argentina
[13] Northwestern Univ, Feinberg Sch Med, Chicago, IL 60611 USA
[14] Charles Univ Prague, Gen Univ Hosp, Prague, Czech Republic
[15] Taipei Vet Gen Hosp, Gen Clin Res Ctr, Taipei, Taiwan
[16] Taipei Vet Gen Hosp, Div Cardiol, Taipei, Taiwan
[17] Natl Yang Ming Chiao Tung Univ, Taipei, Taiwan
[18] Univ Barcelona, Bellvitge Univ Hosp, Dept Cardiol, Barcelona, Spain
[19] Univ Barcelona, Bellvitge Biomed Res Inst, Barcelona, Spain
[20] George Emil Palade Univ Med, Pharm Sci & Technol, Targu Mures, Romania
[21] Med Univ Lodz, Dept Cardiol, Lodz, Poland
[22] Univ Utah, Med Ctr, Salt Lake City, UT USA
[23] Ctr Estudios Clin Queretaro, Queretaro, Mexico
[24] King Saud Univ, Cardiac Sci Dept, Riyadh, Saudi Arabia
[25] Gen Hosp Northern Theater Command, Cardiovasc Res Inst, Shenyang, Liaoning, Peoples R China
[26] Clin Vesalio, San Borja, Peru
[27] Univ Hosp Leuven, Dept Cardiovasc Dis, Cardiac Intens Care, Leuven, Belgium
[28] Natl Cardiol Hosp, Dept Noninvas Cardiol, Sofia, Bulgaria
[29] Kinshukai Hanwa Daini Senboku Hosp, Osaka, Japan
[30] Semmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary
[31] Univ Montreal, Inst Cardiol Montreal, Montreal, PQ, Canada
[32] Univ Toronto, Div Cardiac Surg, St Michaels Hosp, Toronto, ON, Canada
[33] Inst Pesquisa Clin Campinas, Cardiovasc Div, Campinas, Brazil
[34] Natl Med Res Ctr Cardiol, Dept Myocardial Dis & Heart Failure, Moscow, Russia
[35] Univ Minnesota, Minneapolis Vet Affairs Ctr Care Delivery & Outco, Minneapolis, MN USA
[36] Tan Tao Univ, Tam Anh Hosp, Cardiovasc Ctr, Tan Duc, Vietnam
[37] AstraZeneca, BioPharmaceut Res & Dev, Late Stage Dev Cardiovasc Renal & Metab, Gothenburg, Sweden
关键词
OUTCOMES;
D O I
10.1056/NEJMoa2206286
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or less. Whether SGLT2 inhibitors are effective in patients with a higher left ventricular ejection fraction remains less certain. METHODS We randomly assigned 6263 patients with heart failure and a left ventricular ejection fraction of more than 40% to receive dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis. RESULTS Over a median of 2.3 years, the primary outcome occurred in 512 of 3131 patients (16.4%) in the dapagliflozin group and in 610 of 3132 patients (19.5%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P < 0.001). Worsening heart failure occurred in 368 patients (11.8%) in the dapagliflozin group and in 455 patients (14.5%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.69 to 0.91); cardiovascular death occurred in 231 patients (7.4%) and 261 patients (8.3%), respectively (hazard ratio, 0.88; 95% CI, 0.74 to 1.05). Total events and symptom burden were lower in the dapagliflozin group than in the placebo group. Results were similar among patients with a left ventricular ejection fraction of 60% or more and those with a left ventricular ejection fraction of less than 60%, and results were similar in prespecified subgroups, including patients with or without diabetes. The incidence of adverse events was similar in the two groups. CONCLUSIONS Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, .)
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收藏
页码:1089 / 1098
页数:10
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