Keywords
diabetes mellitus
myocardial infarction
cardiovascular diseases
myocardial infarction
cardiovascular diseases
How to Cite
Ramírez-Ramos, C. F., Betancur, K., Castilla, G. A., Saldarriaga, S., Aranzazu-Uribe, M., Ramírez Méndez, D. A., Herrera Céspedes, E., Salamanca-Montilla, J. F., Martínez, C. A., & Saldarriaga, C. (2020). Diabetes and cardiovascular disease, current aspects of its management: the cardiologist’s visión. Revista Colombiana De Endocrinología, Diabetes &Amp; Metabolismo, 7(2), 110–115. https://doi.org/10.53853/encr.7.2.610
Abstract
Diabetes is a prevalent disease with increasing cases worldwide and related to other conditions such as obesity. This disease imposes a greater cardiovascular risk to patients who suffer from it by causing myocardial infarction, cerebrovascular events and peripheral arterial disease, notable causes of morbidity and mortality.
Over the last years we have had a change in the paradigm of the management of this condition, leaving aside a glucocentric approach to make an integral approximation of the global risk and other associated factors. Recent studies have provided valuable information on cardiovascular safety but the most interesting have shown that some pharmacological groups have an additional benefit in this population with a decrease in cardiovascular conditions, with such an impact that they are being taken as the initial management strategy for this disease.
References
1. Glovaci D, Fan W, Wong ND. Epidemiology of Diabetes Mellitus and Cardiovascular Disease. Curr Cardiol Rep. 2019;21(4):21.
2. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet Lond Engl. 2016;387(10027):1513–30.
3. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917–28.
4. American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S111–34.
5. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457–71.
6. Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020;41(2):255–323.
7. Morrish NJ, Wang SL, Stevens LK, Fuller JH, Keen H. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(Suppl 2):S14-21.
8. Manson JE, Colditz GA, Stampfer MJ, Willett WC, Krolewski AS, Rosner B, et al. A prospective study of maturity-onset diabetes mellitus and risk of coronary heart disease and stroke in women. Arch Intern Med. 1991;151(6):1141–7.
9. Wei M, Gaskill SP, Haffner SM, Stern MP. Effects of diabetes and level of glycemia on all-cause and cardiovascular mortality. The San Antonio Heart Study. Diabetes Care. 1998;21(7):1167–72.
10. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, et al. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014;129(3):e28–292.
11. Emerging Risk Factors Collaboration, Sarwar N, Gao P, Seshasai SRK, Gobin R, Kaptoge S, et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet Lond Engl. 2010;375(9733):2215–22.
12. Zuanetti G, Latini R, Maggioni AP, Santoro L, Franzosi MG. Influence of diabetes on mortality in acute myocardial infarction: data from the GISSI-2 study. J Am Coll Cardiol. 1993;22(7):1788–94.
13. Juutilainen A, Lehto S, Rönnemaa T, Pyörälä K, Laakso M. Type 2 diabetes as a “coronary heart disease equivalent”: an 18-year prospective population-based study in Finnish subjects. Diabetes Care. 2005;28(12):2901–7.
14. Hu FB, Stampfer MJ, Solomon CG, Liu S, Willett WC, Speizer FE, et al. The impact of diabetes mellitus on mortality from all causes and coronary heart disease in women: 20 years of follow-up. Arch Intern Med. 2001;161(14):1717–23.
15. Bulugahapitiya U, Siyambalapitiya S, Sithole J, Idris I. Is diabetes a coronary risk equivalent? Systematic review and meta-analysis. Diabet Med J Br Diabet Assoc. 2009;26(2):142–8.
16. Wong ND, Glovaci D, Wong K, Malik S, Franklin SS, Wygant G, et al. Global cardiovascular disease risk assessment in United States adults with diabetes. Diab Vasc Dis Res. 2012;9(2):146–52.
17. Ford ES. Trends in the risk for coronary heart disease among adults with diagnosed diabetes in the U.S.: findings from the National Health and Nutrition Examination Survey, 1999-2008. Diabetes Care. 2011;34(6):1337– 43.
18. Rana JS, Liu JY, Moffet HH, Jaffe M, Karter AJ. Diabetes and Prior Coronary Heart Disease are Not Necessarily Risk Equivalent for Future Coronary Heart Disease Events. J Gen Intern Med. 2016;31(4):387–93.
19. Malik S, Budoff MJ, Katz R, Blumenthal RS, Bertoni AG, Nasir K, et al. Impact of subclinical atherosclerosis on cardiovascular disease events in individuals with metabolic syndrome and diabetes: the multi-ethnic study of atherosclerosis. Diabetes Care. 2011;34(10):2285–90.
20. Arnold SV, Lipska KJ, Li Y, McGuire DK, Goyal A, Spertus JA, et al. Prevalence of glucose abnormalities among patients presenting with an acute myocardial infarction. Am Heart J. 2014;168(4):466-470.e1.
21. Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015;116(9):1509–26.
22. Uccioli L, Gandini R, Giurato L, Fabiano S, Pampana E, Spallone V, et al. Longterm outcomes of diabetic patients with critical limb ischemia followed in a tertiary referral diabetic foot clinic. Diabetes Care. 2010;33(5):977–82.
23. Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834–44.
24. Boonman-de Winter LJM, Rutten FH, Cramer MJM, Landman MJ, Liem AH, Rutten GEHM, et al. High prevalence of previously unknown heart failure and left ventricular dysfunction in patients with type 2 diabetes. Diabetologia. 2012;55(8):2154–62.
25. Nichols GA, Hillier TA, Erbey JR, Brown JB. Congestive heart failure in type 2 diabetes: prevalence, incidence, and risk factors. Diabetes Care. 2001;24(9):1614–9.
26. Matsushita K, Blecker S, Pazin-Filho A, Bertoni A, Chang PP, Coresh J, et al. The association of hemoglobin a1c with incident heart failure among people without diabetes: the atherosclerosis risk in communities study. Diabetes. 2010;59(8):2020–6.
27. Amato L, Paolisso G, Cacciatore F, Ferrara N, Ferrara P, Canonico S, et al. Congestive heart failure predicts the development of non-insulin-dependent diabetes mellitus in the elderly. The Osservatorio Geriatrico Regione Campania Group. Diabetes Metab. 1997;23(3):213–8.
28. Johansson I, Dahlström U, Edner M, Näsman P, Rydén L, Norhammar A. Type 2 diabetes and heart failure: Characteristics and prognosis in preserved, mid-range and reduced ventricular function. Diab Vasc Dis Res. 2018;15(6):494–503.
29. McMurray JJV, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993–1004.
30. MacDonald MR, Petrie MC, Varyani F, Ostergren J, Michelson EL, Young JB, et al. Impact of diabetes on outcomes in patients with low and preserved ejection fraction heart failure: an analysis of the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) programme. Eur Heart J. 2008;29(11):1377–85.
31. Kristensen SL, Jhund PS, Lee MMY, Køber L, Solomon SD, Granger CB, et al. Prevalence of Prediabetes and Undiagnosed Diabetes in Patients with HFpEF and HFrEF and Associated Clinical Outcomes. Cardiovasc Drugs Ther. 2017;31(5–6):545–9.
32. Pavlovi? A, Polovina M, Risti? A, Seferovi? JP, Velji? I, Simeunovi? D, et al. Long-term mortality is increased in patients with undetected prediabetes and type-2 diabetes hospitalized for worsening heart failure and reduced ejection fraction. Eur J Prev Cardiol. 2019;26(1):72–82.
33. Targher G, Dauriz M, Laroche C, Temporelli PL, Hassanein M, Seferovic PM, et al. In-hospital and 1-year mortality associated with diabetes in patients with acute heart failure: results from the ESC-HFA Heart Failure LongTerm Registry. Eur J Heart Fail. 2017;19(1):54–65.
34. Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, et al. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015;373(23):2247–57.
35. Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, et al. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2017;377(13):1228–39.
36. Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JFE, Nauck MA, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016;375(4):311–22.
37. Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834–44.
38. Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, et al. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2019;381(9):841–51.
39. Hernandez AF, Green JB, Janmohamed S, D’Agostino RB, Granger CB, Jones NP, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet Lond Engl. 2018;392(10157):1519–29.
40. Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Furtado RHM, et al. Comparison of the Effects of Glucagon-Like Peptide Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Major Adverse Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus. Circulation. 2019;139(17):2022–31.
41. Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet Lond Engl. 2019;394(10193):121–30.
42. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117–28.
43. Neal B, Perkovic V, Matthews DR, Mahaffey KW, Fulcher G, Meininger G, et al. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): A randomized, placebo-controlled trial. Diabetes Obes Metab. 2017;19(3):387–93.
44. Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019;380(4):347–57.
45. Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019;380(24):2295–306.
46. McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381(21):1995–2008.
2. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet Lond Engl. 2016;387(10027):1513–30.
3. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917–28.
4. American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S111–34.
5. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457–71.
6. Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020;41(2):255–323.
7. Morrish NJ, Wang SL, Stevens LK, Fuller JH, Keen H. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(Suppl 2):S14-21.
8. Manson JE, Colditz GA, Stampfer MJ, Willett WC, Krolewski AS, Rosner B, et al. A prospective study of maturity-onset diabetes mellitus and risk of coronary heart disease and stroke in women. Arch Intern Med. 1991;151(6):1141–7.
9. Wei M, Gaskill SP, Haffner SM, Stern MP. Effects of diabetes and level of glycemia on all-cause and cardiovascular mortality. The San Antonio Heart Study. Diabetes Care. 1998;21(7):1167–72.
10. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, et al. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014;129(3):e28–292.
11. Emerging Risk Factors Collaboration, Sarwar N, Gao P, Seshasai SRK, Gobin R, Kaptoge S, et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet Lond Engl. 2010;375(9733):2215–22.
12. Zuanetti G, Latini R, Maggioni AP, Santoro L, Franzosi MG. Influence of diabetes on mortality in acute myocardial infarction: data from the GISSI-2 study. J Am Coll Cardiol. 1993;22(7):1788–94.
13. Juutilainen A, Lehto S, Rönnemaa T, Pyörälä K, Laakso M. Type 2 diabetes as a “coronary heart disease equivalent”: an 18-year prospective population-based study in Finnish subjects. Diabetes Care. 2005;28(12):2901–7.
14. Hu FB, Stampfer MJ, Solomon CG, Liu S, Willett WC, Speizer FE, et al. The impact of diabetes mellitus on mortality from all causes and coronary heart disease in women: 20 years of follow-up. Arch Intern Med. 2001;161(14):1717–23.
15. Bulugahapitiya U, Siyambalapitiya S, Sithole J, Idris I. Is diabetes a coronary risk equivalent? Systematic review and meta-analysis. Diabet Med J Br Diabet Assoc. 2009;26(2):142–8.
16. Wong ND, Glovaci D, Wong K, Malik S, Franklin SS, Wygant G, et al. Global cardiovascular disease risk assessment in United States adults with diabetes. Diab Vasc Dis Res. 2012;9(2):146–52.
17. Ford ES. Trends in the risk for coronary heart disease among adults with diagnosed diabetes in the U.S.: findings from the National Health and Nutrition Examination Survey, 1999-2008. Diabetes Care. 2011;34(6):1337– 43.
18. Rana JS, Liu JY, Moffet HH, Jaffe M, Karter AJ. Diabetes and Prior Coronary Heart Disease are Not Necessarily Risk Equivalent for Future Coronary Heart Disease Events. J Gen Intern Med. 2016;31(4):387–93.
19. Malik S, Budoff MJ, Katz R, Blumenthal RS, Bertoni AG, Nasir K, et al. Impact of subclinical atherosclerosis on cardiovascular disease events in individuals with metabolic syndrome and diabetes: the multi-ethnic study of atherosclerosis. Diabetes Care. 2011;34(10):2285–90.
20. Arnold SV, Lipska KJ, Li Y, McGuire DK, Goyal A, Spertus JA, et al. Prevalence of glucose abnormalities among patients presenting with an acute myocardial infarction. Am Heart J. 2014;168(4):466-470.e1.
21. Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015;116(9):1509–26.
22. Uccioli L, Gandini R, Giurato L, Fabiano S, Pampana E, Spallone V, et al. Longterm outcomes of diabetic patients with critical limb ischemia followed in a tertiary referral diabetic foot clinic. Diabetes Care. 2010;33(5):977–82.
23. Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834–44.
24. Boonman-de Winter LJM, Rutten FH, Cramer MJM, Landman MJ, Liem AH, Rutten GEHM, et al. High prevalence of previously unknown heart failure and left ventricular dysfunction in patients with type 2 diabetes. Diabetologia. 2012;55(8):2154–62.
25. Nichols GA, Hillier TA, Erbey JR, Brown JB. Congestive heart failure in type 2 diabetes: prevalence, incidence, and risk factors. Diabetes Care. 2001;24(9):1614–9.
26. Matsushita K, Blecker S, Pazin-Filho A, Bertoni A, Chang PP, Coresh J, et al. The association of hemoglobin a1c with incident heart failure among people without diabetes: the atherosclerosis risk in communities study. Diabetes. 2010;59(8):2020–6.
27. Amato L, Paolisso G, Cacciatore F, Ferrara N, Ferrara P, Canonico S, et al. Congestive heart failure predicts the development of non-insulin-dependent diabetes mellitus in the elderly. The Osservatorio Geriatrico Regione Campania Group. Diabetes Metab. 1997;23(3):213–8.
28. Johansson I, Dahlström U, Edner M, Näsman P, Rydén L, Norhammar A. Type 2 diabetes and heart failure: Characteristics and prognosis in preserved, mid-range and reduced ventricular function. Diab Vasc Dis Res. 2018;15(6):494–503.
29. McMurray JJV, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993–1004.
30. MacDonald MR, Petrie MC, Varyani F, Ostergren J, Michelson EL, Young JB, et al. Impact of diabetes on outcomes in patients with low and preserved ejection fraction heart failure: an analysis of the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) programme. Eur Heart J. 2008;29(11):1377–85.
31. Kristensen SL, Jhund PS, Lee MMY, Køber L, Solomon SD, Granger CB, et al. Prevalence of Prediabetes and Undiagnosed Diabetes in Patients with HFpEF and HFrEF and Associated Clinical Outcomes. Cardiovasc Drugs Ther. 2017;31(5–6):545–9.
32. Pavlovi? A, Polovina M, Risti? A, Seferovi? JP, Velji? I, Simeunovi? D, et al. Long-term mortality is increased in patients with undetected prediabetes and type-2 diabetes hospitalized for worsening heart failure and reduced ejection fraction. Eur J Prev Cardiol. 2019;26(1):72–82.
33. Targher G, Dauriz M, Laroche C, Temporelli PL, Hassanein M, Seferovic PM, et al. In-hospital and 1-year mortality associated with diabetes in patients with acute heart failure: results from the ESC-HFA Heart Failure LongTerm Registry. Eur J Heart Fail. 2017;19(1):54–65.
34. Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, et al. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015;373(23):2247–57.
35. Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, et al. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2017;377(13):1228–39.
36. Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JFE, Nauck MA, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016;375(4):311–22.
37. Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834–44.
38. Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, et al. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2019;381(9):841–51.
39. Hernandez AF, Green JB, Janmohamed S, D’Agostino RB, Granger CB, Jones NP, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet Lond Engl. 2018;392(10157):1519–29.
40. Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Furtado RHM, et al. Comparison of the Effects of Glucagon-Like Peptide Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Major Adverse Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus. Circulation. 2019;139(17):2022–31.
41. Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet Lond Engl. 2019;394(10193):121–30.
42. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117–28.
43. Neal B, Perkovic V, Matthews DR, Mahaffey KW, Fulcher G, Meininger G, et al. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): A randomized, placebo-controlled trial. Diabetes Obes Metab. 2017;19(3):387–93.
44. Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019;380(4):347–57.
45. Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019;380(24):2295–306.
46. McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381(21):1995–2008.
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