The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics

European Journal of Heart Failure

Volumn 21, Issue 11, 2019, Pages 1402-1411

  McMurray, John J V ^a   DeMets, David L ^b   Inzucchi, Silvio E ^c   Køber, Lars ^d   Kosiborod, Mikhail N ^e   Langkilde, Anna Maria ^f   Martinez, Felipe A ^g   Bengtsson, Olof ^f   Ponikowski, Piotr ^h   Sabatine, Marc S ⁱ   Sjöstrand, Mikaela ^f   Solomon, Scott D ^j  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d International Center for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health   (Denmark)

^e SAINT LUKE S MID AMERICA HEART INSTITUTE   (United States)

^f ASTRAZENECA R AND D   (Sweden)

^g UNIVERSIDAD NACIONAL DE CÓRDOBA   (Argentina)

^h WROCLAW MEDICAL UNIVERSITY   (Poland)

ⁱ HARVARD MEDICAL SCHOOL   (United States)

^j BRIGHAM AND WOMEN S HOSPITAL   (United States)

more..

Author keywords

Diabetes; Heart failure; Natriuretic peptides; Pre diabetes; SGLT2 inhibitor

Indexed keywords

AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DAPAGLIFLOZIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENKEPHALINASE INHIBITOR; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C; INSULIN; IVABRADINE; MINERALOCORTICOID ANTAGONIST; PLACEBO; SACUBITRIL PLUS VALSARTAN; 2-(3-(4-ETHOXYBENZYL)-4-CHLOROPHENYL)-6-HYDROXYMETHYLTETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; BENZHYDRYL DERIVATIVE; BRAIN NATRIURETIC PEPTIDE; GLUCOSIDE; HEMOGLOBIN A1C PROTEIN, HUMAN; PEPTIDE FRAGMENT; PRO-BRAIN NATRIURETIC PEPTIDE (1-76);

ADULT; ADVERSE OUTCOME; AGED; ARTICLE; COMORBIDITY; CONTROLLED STUDY; DISEASE REGISTRY; DOUBLE BLIND PROCEDURE; FEMALE; HEART FAILURE WITH REDUCED EJECTION FRACTION; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; IMPAIRED GLUCOSE TOLERANCE; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; NEW YORK HEART ASSOCIATION CLASS; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; PROPHYLAXIS; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RENAL PROTECTION; BLOOD; DIABETIC COMPLICATION; HEART FAILURE; METABOLISM; MIDDLE AGED; REFERENCE VALUE; REGISTER; TREATMENT OUTCOME;

AGED; BENZHYDRYL COMPOUNDS; DIABETES COMPLICATIONS; FEMALE; GLUCOSIDES; GLYCATED HEMOGLOBIN A; HEART FAILURE; HUMANS; MALE; MIDDLE AGED; NATRIURETIC PEPTIDE, BRAIN; PEPTIDE FRAGMENTS; PREDIABETIC STATE; REFERENCE VALUES; REGISTRIES; TREATMENT OUTCOME;

EID: 85069834349     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1002/ejhf.1548     Document Type: Article

References (38)

1. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373:2117–2128.
2. Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 2017;377:644–657.
3. Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JP, Ruff CT, Gause-Nilsson IA, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE–TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347–357.
4. Packer M, Anker SD, Butler J, Filippatos G, Zannad F. Effects of sodium-glucose cotransporter 2 inhibitors for the treatment of patients with heart failure: proposal of a novel mechanism of action. JAMA Cardiol 2017;2:1025–1029.
5. Verma S, McMurray JJ. SGLT2 inhibitors and mechanisms of cardiovascular benefit: a state-of-the-art review. Diabetologia 2018;61:2108–2117.
6. Zelniker TA, Braunwald E. Cardiac and renal effects of sodium-glucose co-transporter 2 inhibitors in diabetes: JACC state-of-the-art review. J Am Coll Cardiol 2018;72:1845–1855.
7. Inzucchi SE, Kosiborod M, Fitchett D, Wanner C, Hehnke U, Kaspers S, George JT, Zinman B. Improvement in cardiovascular outcomes with empagliflozin is independent of glycemic control. Circulation 2018;138:1904–1907.
8. Lytvyn Y, Bjornstad P, Udell JA, Lovshin JA, Cherney DZI. Sodium glucose cotransporter-2 inhibition in heart failure: potential mechanisms, clinical applications, and summary of clinical trials. Circulation 2017;136:1643–1658.
9. Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med 2016;375:323–334.
10. McMurray JJ, DeMets DL, Inzucchi SE, Køber L, Kosiborod MN, Langkilde AM, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjöstrand M, Solomon SD; DAPA-HF Committees and Investigators. A trial to evaluate the effect of the sodium glucose co-transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA-HF). Eur J Heart Fail 2019;21:665–675.
11. Chioncel O, Lainscak M, Seferovic PM, Anker SD, Crespo-Leiro MG, Harjola VP, Parissis J, Laroche C, Piepoli MF, Fonseca C, Mebazaa A, Lund L, Ambrosio GA, Coats AJ, Ferrari R, Ruschitzka F, Maggioni AP, Filippatos G. Epidemiology and one-year outcomes in patients with chronic heart failure and preserved, mid-range and reduced ejection fraction: an analysis of the ESC Heart Failure Long-Term Registry. Eur J Heart Fail 2017;19:1574–1585.
12. Maggioni AP, Anker SD, Dahlström U, Filippatos G, Ponikowski P, Zannad F, Amir O, Chioncel O, Leiro MC, Drozdz J, Erglis A, Fazlibegovic E, Fonseca C, Fruhwald F, Gatzov P, Goncalvesova E, Hassanein M, Hradec J, Kavoliuniene A, Lainscak M, Logeart D, Merkely B, Metra M, Persson H, Seferovic P, Temizhan A, Tousoulis D, Tavazzi L; Heart Failure Association of the ESC. Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12,440 patients of the ESC Heart Failure Long-Term Registry. Eur J Heart Fail 2013;15:1173–1184.
13. Khariton Y, Hernandez AF, Fonarow GC, Sharma PP, Duffy CI, Thomas L, Mi X, Albert NM, Butler J, McCague K, Nassif ME, Williams FB, DeVore A, Patterson JH, Spertus JA. Health status variation across practices in outpatients with heart failure: insights from the CHAMP-HF (Change the Management of Patients with Heart Failure) registry. Circ Cardiovasc Qual Outcomes 2018;11:e004668.
14. Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical therapy for heart failure with reduced ejection fraction: the CHAMP-HF registry. J Am Coll Cardiol 2018;72:351–366.
15. Lam CS, Teng TK, Tay WT, Anand I, Zhang S, Shimizu W, Narasimhan C, Park SW, Yu CM, Ngarmukos T, Omar R, Reyes EB, Siswanto BB, Hung CL, Ling LH, Yap J, MacDonald M, Richards AM. Regional and ethnic differences among patients with heart failure in Asia: the Asian sudden cardiac death in heart failure registry. Eur Heart J 2016;37:3141–3153.
16. Chandramouli C, Teng TK, Tay WT, Yap J, MacDonald MR, Tromp J, Yan L, Siswanto B, Reyes EB, Ngarmukos T, Yu CM, Hung CL, Anand I, Richards AM, Ling LH, Regensteiner JG, Lam CS; ASIAN-HF Investigators. Impact of diabetes and sex in heart failure with reduced ejection fraction patients from the ASIAN-HF registry. Eur J Heart Fail 2019;21:297–307.
17. Teng TK, Tromp J, Tay WT, Anand I, Ouwerkerk W, Chopra V, Wander GS, Yap JJ, MacDonald MR, Xu CF, Chia YM, Shimizu W, Richards AM, Voors A, Lam CS, ASIAN-HF Investigators. Prescribing patterns of evidence-based heart failure pharmacotherapy and outcomes in the ASIAN-HF registry: a cohort study. Lancet Glob Health 2018;6:e1008–e1018.
18. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and CommitteesAngiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med 2014;371:993–1004.
19. McMurray JJ, Krum H, Abraham WT, Dickstein K, Køber LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, enalapril, or aliskiren and enalapril in heart failure. N Engl J Med 2016;374:1521–1532.
20. Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet 2010;376:875–885.
21. Zannad F, Anker SD, Byra WM, Cleland JG, Fu M, Gheorghiade M, Lam CS, Mehra MR, Neaton JD, Nessel CC, Spiro TE, van Veldhuisen DJ, Greenberg B; COMMANDER HF Investigators. Rivaroxaban in patients with heart failure, sinus rhythm, and coronary disease. N Engl J Med 2018;379:1332–1342.
22. Butler J, Hamo CE, Filippatos G, Pocock SJ, Bernstein RA, Brueckmann M, Cheung AK, George JT, Green JB, Januzzi JL, Kaul S, Lam CS, Lip GY, Marx N, McCullough PA, Mehta CR, Ponikowski P, Rosenstock J, Sattar N, Salsali A, Scirica BM, Shah SJ, Tsutsui H, Verma S, Wanner C, Woerle HJ, Zannad F, Anker SD; EMPEROR Trials Program. The potential role and rationale for treatment of heart failure with sodium-glucose co-transporter 2 inhibitors. Eur J Heart Fail 2017;19:1390–1400.
23. Kristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJ, Køber L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail 2018;20:136–147.
24. Ziff OJ, Lane DA, Samra M, Griffith M, Kirchhof P, Lip GY, Steeds RP, Townend J, Kotecha D. Safety and efficacy of digoxin: systematic review and meta-analysis of observational and controlled trial data. BMJ 2015;351:h4451.
25. Desai NR, Ross JS, Kwon JY, Herrin J, Dharmarajan K, Bernheim SM, Krumholz HM, Horwitz LI. Association between hospital penalty status under the hospital readmission reduction program and readmission rates for target and nontarget conditions. JAMA 2016;316:2647–2656.
26. Kristensen SL, Preiss D, Jhund PS, Squire I, Cardoso JS, Merkely B, Martinez F, Starling RC, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, McMurray JJ, Packer M; PARADIGM-HF Investigators and Committees. Risk related to pre-diabetes mellitus and diabetes mellitus in heart failure with reduced ejection fraction: insights from Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure trial. Circ Heart Fail 2016;9:e002560.
27. Dauriz M, Targher G, Temporelli PL, Lucci D, Gonzini L, Nicolosi GL, Marchioli R, Tognoni G, Latini R, Cosmi F, Tavazzi L, Maggioni AP; GISSI-HF Investigators. Prognostic impact of diabetes and prediabetes on survival outcomes in patients with chronic heart failure: a post-hoc analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial. J Am Heart Assoc 2017;6:e005156.
28. Scrutinio D, Passantino A, Santoro D, Catanzaro R. The cardiorenal anaemia syndrome in systolic heart failure: prevalence, clinical correlates, and long-term survival. Eur J Heart Fail 2011;13:61–67.
29. DeVore AD, Mi X, Thomas L, Sharma PP, Albert NM, Butler J, Hernandez AF, Patterson JH, Spertus JA, Williams FB, Duffy CI, McCague K, Fonarow GC. Characteristics and treatments of patients enrolled in the CHAMP-HF registry compared with patients enrolled in the PARADIGM-HF trial. J Am Heart Assoc 2018;7:e009237.
30. Seferovic JP, Claggett B, Seidelmann SB, Seely EW, Packer M, Zile MR, Rouleau JL, Swedberg K, Lefkowitz M, Shi VC, Desai AS, McMurray JJ, Solomon SD. Effect of sacubitril/valsartan versus enalapril on glycaemic control in patients with heart failure and diabetes: a post-hoc analysis from the PARADIGM-HF trial. Lancet Diabetes Endocrinol 2017;5:333–340.
31. Komajda M, Tavazzi L, Francq BG, Böhm M, Borer JS, Ford I, Swedberg K; SHIFT Investigators. Efficacy and safety of ivabradine in patients with chronic systolic heart failure and diabetes: an analysis from the SHIFT trial. Eur J Heart Fail 2015;17:1294–1301.
32. Dauriz M, Targher G, Laroche C, Temporelli PL, Ferrari R, Anker S, Coats A, Filippatos G, Crespo-Leiro M, Mebazaa A, Piepoli MF, Maggioni AP, Tavazzi L; ESC-HFA Heart Failure Long-Term Registry. Association between diabetes and 1-year adverse clinical outcomes in a multinational cohort of ambulatory patients with chronic heart failure: results from the ESC-HFA Heart Failure Long-Term Registry. Diabetes Care 2017;40:671–678.
33. Arnold SV, Yap J, Lam CS, Tang F, Tay WT, Teng TH, McGuire DK, Januzzi JL, Fonarow GC, Masoudi FA, Kosiborod M. Management of patients with diabetes and heart failure with reduced ejection fraction: an international comparison. Diabetes Obes Metab 2019;21:261–226.
34. Gerstein HC, Bosch J, Dagenais GR, Díaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Rydén LE, Yusuf S, ORIGIN Trial Investigators. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012;367:319–328.
35. Sarma S, Mentz RJ, Kwasny MJ, Fought AJ, Huffman M, Subacius H, Nodari S, Konstam M, Swedberg K, Maggioni AP, Zannad F, Bonow RO, Gheorghiade M; EVEREST Investigators. Association between diabetes mellitus and post-discharge outcomes in patients hospitalized with heart failure: findings from the EVEREST trial. Eur J Heart Fail 2013;15:194–202.
36. Eeg-Olofsson K, Zethelius B, Gudbjörnsdottir S, Eliasson B, Svensson AM, Cederholm J. Considerably decreased risk of cardiovascular disease with combined reductions in HbA1c, blood pressure and blood lipids in type 2 diabetes: report from the Swedish National Diabetes Register. Diab Vasc Dis Res 2016;13:268–277.
37. Arnold SV, Echouffo-Tcheugui JB, Lam CS, Inzucchi SE, Tang F, McGuire DK, Goyal A, Maddox TM, Sperling LS, Fonarow GC, Masoudi FA, Kosiborod M. Patterns of glucose-lowering medication use in patients with type 2 diabetes and heart failure. Insights from the Diabetes Collaborative Registry (DCR). Am Heart J 2018;203:25–29.
38. Seferović PM, Petrie MC, Filippatos GS, Anker SD, Rosano G, Bauersachs J, Paulus WJ, Komajda M, Cosentino F, de Boer RA, Farmakis D, Doehner W, Lambrinou E, Lopatin Y, Piepoli MF, Theodorakis MJ, Wiggers H, Lekakis J, Mebazaa A, Mamas MA, Tschöpe C, Hoes AW, Seferović JP, Logue J, McDonagh T, Riley JP, Milinković I, Polovina M, van Veldhuisen DJ, Lainscak M, Maggioni AP, Ruschitzka F, McMurray JJ. Type 2 diabetes mellitus and heart failure: a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail 2018;20:853–872.