Sotagliflozin in patients with diabetes and recent worsening heart failure

New England Journal of Medicine

Volumn 384, Issue 2, 2021, Pages 117-128

  Bhatt, Deepak L ^a   Szarek, Michael ^b,c   Gabriel Steg, P ^d   Cannon, Christopher P ^a   Leiter, Lawrence A ^f,g,h   McGuire, Darren K ⁱ   Lewis, Julia B ^k   Riddle, Matthew C ^l   Voors, Adriaan A ^m   Metra, Marco ⁿ   Lund, Lars H ^o   Komajda, Michel ^e   Testani, Jeffrey M ^p   Wilcox, Christopher S ^q   Ponikowski, Piotr ^r   Lopes, Renato D ^s   Verma, Subodh ^f,g   Lapuerta, Pablo ^j   Pitt, Bertram ^t  

^a HARVARD MEDICAL SCHOOL   (United States)

^b Anschutz Medical Campus ^*  (United States)

^c SUNY DOWNSTATE MEDICAL CENTER   (United States)

^d UNIVERSITÉ PARIS DESCARTES   (France)

^e SORBONNE UNIVERSITÉ   (France)

^f ST MICHAEL'S HOSPITAL   (Canada)

^g UNIVERSITY OF TORONTO   (Canada)

^h ST MICHAEL'S HOSPITAL   (Canada)

ⁱ UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^j LEXICON PHARMACEUTICALS INC   (United States)

^k VANDERBILT UNIVERSITY   (United States)

^l OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^m UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

ⁿ UNIVERSITY OF BRESCIA   (Italy)

^o KAROLINSKA INSTITUTE   (Sweden)

^p YALE UNIVERSITY   (United States)

^q GEORGETOWN UNIVERSITY   (United States)

^r WROCLAW MEDICAL UNIVERSITY   (Poland)

^s DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^t UNIVERSITY OF MICHIGAN   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SOTAGLIFLOZIN; (2S,3R,4R,5S,6R)-2-(4-CHLORO-3-(4-ETHOXYBENZYL)PHENYL)-6-(METHYLTHIO)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; GLYCOSIDE; SODIUM GLUCOSE COTRANSPORTER 1;

ACUTE KIDNEY FAILURE; ADULT; AGED; ARTICLE; CARDIOVASCULAR DISEASE; CAUSE OF DEATH; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG FATALITY; DRUG SAFETY; FEMALE; HEART FAILURE; HOSPITAL DISCHARGE; HOSPITALIZATION; HUMAN; HYPOGLYCEMIA; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; MORTALITY RATE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; ADVERSE EVENT; CLINICAL TRIAL; COMPLICATION; MIDDLE AGED; MORTALITY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

ACUTE KIDNEY INJURY; AGED; CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; GLYCOSIDES; HEART FAILURE; HOSPITALIZATION; HUMANS; HYPOTENSION; MALE; MIDDLE AGED; SODIUM-GLUCOSE TRANSPORTER 1; SODIUM-GLUCOSE TRANSPORTER 2 INHIBITORS;

EID: 85099764927     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa2030183     Document Type: Article

References (51)

1. Bhatt DL, Verma S, Braunwald E. The DAPA-HF trial: a momentous victory in the war against heart failure. Cell Metab 2019; 30: 847-9.
2. Verma S, Bhatt DL. More CREDENCE for SGLT2 inhibition. Circulation 2019; 140: 1448-50.
3. Connelly KA, Bhatt DL, Verma S. Can we DECLARE a victory against cardiorenal disease in diabetes? Cell Metab 2018; 28: 813-5.
4. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015; 373: 2117-28.
5. Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 2017; 377: 644-57.
6. Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019; 380: 2295-306.
7. Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019; 380: 347-57.
8. Cavender MA, Steg PG, Smith SC Jr, et al. Impact of diabetes mellitus on hospitalization for heart failure, cardiovascular events, and death: outcomes at 4 years from the Reduction of Atherothrombosis for Continued Health (REACH) registry. Circulation 2015; 132: 923-31.
9. Scirica BM, Bhatt DL, Braunwald E, et al. Prognostic implications of biomarker assessments in patients with type 2 diabetes at high cardiovascular risk: a secondary analysis of a randomized clinical trial. JAMA Cardiol 2016; 1: 989-98.
10. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013; 369: 1317-26.
11. Scirica BM, Braunwald E, Raz I, et al. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVORTIMI 53 randomized trial. Circulation 2015; 132(15): e198.
12. Scirica BM, Braunwald E, Raz I, et al. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVORTIMI 53 randomized trial. Circulation 2014; 130: 1579-88.
13. Udell JA, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 trial. Diabetes Care 2015; 38: 696-705.
14. Udell JA, Cavender MA, Bhatt DL, Chatterjee S, Farkouh ME, Scirica BM. Glucose-lowering drugs or strategies and cardiovascular outcomes in patients with or at risk for type 2 diabetes: a meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol 2015; 3: 356-66.
15. Bhatt DL, Steg PG, Ohman EM, et al. International prevalence, recognition, and treatment of cardiovascular risk factors in outpatients with atherothrombosis. JAMA 2006; 295: 180-9.
16. Steg PG, Bhatt DL, Wilson PW, et al. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA 2007; 297: 1197-206.
17. Bhatt DL, Eagle KA, Ohman EM, et al. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA 2010; 304: 1350-7.
18. Kato ET, Silverman MG, Mosenzon O, et al. Effect of dapagliflozin on heart failure and mortality in type 2 diabetes mellitus. Circulation 2019; 139: 2528-36.
19. Zelniker TA, Wiviott SD, Raz I, et al. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet 2019; 393: 31-9.
20. Vaduganathan M, Sathiyakumar V, Singh A, et al. Prescriber patterns of SGLT2i after expansions of U.S. Food and Drug Administration labeling. J Am Coll Cardiol 2018; 72: 3370-2.
21. Heerspink HJL, Stefánsson BV, Correa-Rotter R, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med 2020; 383: 1436-46.
22. Cannon CP, Pratley R, Dagogo-Jack S, et al. Cardiovascular outcomes with ertugliflozin in type 2 diabetes. N Engl J Med 2020; 383: 1425-35.
23. McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med 2019; 381: 1995-2008.
24. Packer M, Anker SD, Butler J, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med 2020; 383: 1413-24.
25. Garg SK, Henry RR, Banks P, et al. Effects of sotagliflozin added to insulin in patients with type 1 diabetes. N Engl J Med 2017; 377: 2337-48.
26. Rodbard HW, Giaccari A, Lajara R, et al. Sotagliflozin added to optimised insulin therapy leads to HbA1c reduction without weight gain in adults with type 1 diabetes: a pooled analysis of inTandem1 and inTandem2. Diabetes Obes Metab 2020 July 3 (Epub ahead of print).
27. Sands AT, Zambrowicz BP, Rosenstock J, et al. Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes. Diabetes Care 2015; 38: 1181-8.
28. Powell DR, Zambrowicz B, Morrow L, et al. Sotagliflozin decreases postprandial glucose and insulin concentrations by delaying intestinal glucose absorption. J Clin Endocrinol Metab 2020; 105(4): e1235-e1249.
29. Buse JB, Garg SK, Rosenstock J, et al. Sotagliflozin in combination with optimized insulin therapy in adults with type 1 diabetes: the North American inTandem1 Study. Diabetes Care 2018; 41: 1970-80.
30. Danne T, Cariou B, Banks P, et al. HbA1c and hypoglycemia reductions at 24 and 52 weeks with sotagliflozin in combination with insulin in adults with type 1 diabetes: the European inTandem2 Study. Diabetes Care 2018; 41: 1981-90.
31. Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol 2000; 35: 1245-55.
32. Andersen PK, Angst J, Ravn H. Modeling marginal features in studies of recurrent events in the presence of a terminal event. Lifetime Data Anal 2019; 25: 681-95.
33. Lin DY, Wei LJ. The robust inference for the Cox proportional hazards model. J Am Stat Assoc 1989; 84: 1074-8.
34. Stukel TA, Glynn RJ, Fisher ES, Sharp SM, Lu-Yao G, Wennberg JE. Standardized rates of recurrent outcomes. Stat Med 1994; 13: 1781-91.
35. Damman K, Beusekamp JC, Boorsma EM, et al. Randomized, double-blind, placebo-controlled, multicentre pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure (EMPA-RESPONSE-AHF). Eur J Heart Fail 2020; 22: 713-22.
36. Hess DA, Terenzi DC, Trac JZ, et al. SGLT2 inhibition with empagliflozin increases circulating provascular progenitor cells in people with type 2 diabetes mellitus. Cell Metab 2019; 30: 609-13.
37. Chowdhury B, Luu AZ, Luu VZ, et al. The SGLT2 inhibitor empagliflozin reduces mortality and prevents progression in experimental pulmonary hypertension. Biochem Biophys Res Commun 2020; 524: 50-6.
38. Kumar N, Garg A, Bhatt DL, et al. Empagliflozin improves cardiorespiratory fitness in type 2 diabetes: translational implications. Can J Physiol Pharmacol 2018; 96: 1184-7.
39. Sherman SE, Bell GI, Teoh H, et al. Canagliflozin improves the recovery of blood flow in an experimental model of severe limb ischemia. JACC Basic Transl Sci 2018; 3: 327-9.
40. Packer M. SGLT2 inhibitors produce cardiorenal benefits by promoting adaptive cellular reprogramming to induce a state of fasting mimicry: a paradigm shift in understanding their mechanism of action. Diabetes Care 2020; 43: 508-11.
41. Avogaro A, Fadini GP, Del Prato S. Reinterpreting cardiorenal protection of renal sodium-glucose cotransporter 2 inhibitors via cellular life history programming. Diabetes Care 2020; 43: 501-7.
42. Verma S, Mazer CD, Bhatt DL, et al. Empagliflozin and cardiovascular outcomes in patients with type 2 diabetes and left ventricular hypertrophy: a subanalysis of the EMPA-REG OUTCOME trial. Diabetes Care 2019; 42: e42-e44.
43. Verma S, Mazer CD, Yan AT, et al. Effect of empagliflozin on left ventricular mass in patients with type 2 diabetes mellitus and coronary artery disease: the EMPA-HEART CardioLink-6 randomized clinical trial. Circulation 2019; 140: 1693-702.
44. Opingari E, Verma S, Connelly KA, et al. The impact of empagliflozin on kidney injury molecule-1: a subanalysis of the Effects of Empagliflozin on Cardiac Structure, Function, and Circulating Biomarkers in Patients with Type 2 Diabetes CardioLink-6 trial. Nephrol Dial Transplant 2020; 35: 895-7.
45. Bagiella E, Bhatt DL, Gaudino M. The consequences of the COVID-19 pandemic on non-COVID-19 clinical trials. J Am Coll Cardiol 2020; 76: 342-5.
46. Gaba P, Bhatt DL. The COVID-19 pandemic: a catalyst to improve clinical trials. Nat Rev Cardiol 2020; 17: 673-5.
47. Gaudino M, Arvind V, Hameed I, et al. Effects of the COVID pandemic on active non-COVID clinical trials. J Am Coll Cardiol 2020; 76: 1605-6.
48. Selvaraj S, Greene SJ, Khatana SAM, Nathan AS, Solomon SD, Bhatt DL. The landscape of cardiovascular clinical trials in the United States initiated before and during COVID-19. J Am Heart Assoc 2020; 9(18): e018274.
49. Bhatt DL, Cryer BL, Contant CF, et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med 2010; 363: 1909-17.
50. Jatene T, Harrington RA, Stone GW, et al. Investigator-reported bleeding versus post hoc adjudication of bleeding: lessons from the CHAMPION PHOENIX trial. J Am Coll Cardiol 2016; 67: 596-8.
51. Tyl B, Lopez Sendon J, Borer JS, et al. Comparison of outcome adjudication by investigators and by a central end point committee in heart failure trials: experience of the SHIFT Heart Failure Study. Circ Heart Fail 2020; 13(7): e006720.