Erratum: Updates on cardiovascular outcome trials in diabetes [Cardiovasc Diabetol., 16, (2017) (128)] DOI: 10.1186/s12933-017-0610-y;Updates on cardiovascular outcome trials in diabetes

Cardiovascular Diabetology

Volumn 16, Issue 1, 2017, Pages

  Schnell, Oliver ^a   Rydén, Lars ^b   Standl, Eberhard ^a   Ceriello, Antonio ^c,d  

^a INSTITUT FÜR DIABETESFORSCHUNG   (Germany)

^b KAROLINSKA INSTITUTE   (Sweden)

^c INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^d IRCCS MULTIMEDICA   (Italy)

Author keywords

ACE; CANVAS program; Cardiovascular risk; CVOT; DEVOTE; Diabetes; EXSCEL; Heart

Indexed keywords

ACARBOSE; ACETYLSALICYLIC ACID; ALBIGLUTIDE; ALOGLIPTIN; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CANAGLIFLOZIN; DAPAGLIFLOZIN; DULAGLUTIDE; EMPAGLIFLOZIN; ERTUGLIFLOZIN; EXENDIN 4; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; INSULIN DEGLUDEC; INSULIN GLARGINE; LINAGLIPTIN; LIRAGLUTIDE; LIXISENATIDE; METFORMIN; OMARIGLIPTIN; PLACEBO; SAXAGLIPTIN; SEMAGLUTIDE; SITAGLIPTIN; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; SULFONYLUREA; UNINDEXED DRUG; ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLUCAGON LIKE PEPTIDE 1 RECEPTOR; SLC5A2 PROTEIN, HUMAN; SODIUM GLUCOSE COTRANSPORTER 2;

ACUTE KIDNEY FAILURE; ACUTE PANCREATITIS; ALBUMINURIA; ALL CAUSE MORTALITY; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; DEATH; DIABETES MELLITUS; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; HEART FAILURE; HEART INFARCTION; HOSPITALIZATION; HUMAN; HYPOGLYCEMIA; IMPAIRED GLUCOSE TOLERANCE; NON INSULIN DEPENDENT DIABETES MELLITUS; REVIEW; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS; AGONISTS; ANTAGONISTS AND INHIBITORS; BLOOD; CLINICAL TRIAL (TOPIC); METABOLISM; PROCEDURES;

CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; GLUCAGON-LIKE PEPTIDE-1 RECEPTOR; HUMANS; HYPOGLYCEMIC AGENTS; SODIUM-GLUCOSE TRANSPORTER 2;

EID: 85030837360     PISSN: None     EISSN: 14752840     Source Type: Journal    
DOI: 10.1186/s12933-017-0633-4     Document Type: Erratum

References (50)

1. Dailey G. Overall mortality in diabetes mellitus: where do we stand today? Diabetes Technol Ther. 2011;13(Suppl 1):S65-74.
2. Barnett KN, et al. A 12-year follow-up study of all-cause and cardiovascular mortality among 10,532 people newly diagnosed with Type 2 diabetes in Tayside, Scotland. Diabet Med. 2010;27(10):1124-9.
3. Holman RR, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359(15):1577-89.
4. Bergenstal RM. Glycemic variability and diabetes complications: does it matter? Simply put, there are better glycemic markers! Diabetes Care. 2015;38(8):1615-21.
5. FDA. Guidance for industry diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Silver Spring: FDA; 2008.
6. EMA. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. London: EMA; 2012.
7. Hirshberg B, Raz I. Impact of the US Food and Drug Administration cardiovascular assessment requirements on the development of novel antidiabetes drugs. Diabetes Care. 2011;34(Suppl 2):S101-6.
8. Schnell O, et al. Current perspectives on cardiovascular outcome trials in diabetes. Cardiovasc Diabetol. 2016;15(1):139.
9. Gerstein HC, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012;367(4):319-28.
10. Marso SP, et al. Efficacy and safety of degludec versus glargine in Type 2 diabetes. N Engl J Med. 2017;377(8):723-32.
11. Regier EE, Venkat MV, Close KL. More than 7 years of hindsight: revisiting the FDA's 2008 guidance on cardiovascular outcomes trials for Type 2 diabetes medications. Clin Diabetes. 2016;34(4):173-80.
12. Scirica BM, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317-26.
13. White WB, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369(14):1327-35.
14. Green JB, et al. Effect of sitagliptin on cardiovascular outcomes in Type 2 diabetes. N Engl J Med. 2015;373(3):232-42.
15. Pfeffer MA, et al. Lixisenatide in patients with Type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015;373(23):2247-57.
16. Marso SP, et al. Liraglutide and cardiovascular outcomes in Type 2 diabetes. N Engl J Med. 2016;375(4):311-22.
17. Marso SP, et al. Semaglutide and cardiovascular outcomes in patients with Type 2 diabetes. N Engl J Med. 2016;375(19):1834-44.
18. Zinman B, et al. Empagliflozin, cardiovascular outcomes, and mortality in Type 2 diabetes. N Engl J Med. 2015;373(22):2117-28.
19. Marso SP, et al. Design of DEVOTE (trial comparing cardiovascular safety of insulin degludec vs insulin glargine in patients with type 2 diabetes at high risk of cardiovascular events)-DEVOTE 1. Am Heart J. 2016;179:175-83.
20. Neal B, et al. Optimizing the analysis strategy for the CANVAS Program: a prespecified plan for the integrated analyses of the CANVAS and CANVAS-R trials. Diabetes Obes Metab. 2017;19(7):926-35.
21. Neal B, et al. Canagliflozin and cardiovascular and renal events in Type 2 diabetes. N Engl J Med. 2017;377(7):644-57.
22. Holman RR, et al. Rationale for and design of the acarbose cardiovascular evaluation (ACE) trial. Am Heart J. 2014;168(1):23-9.
23. Holman RR, et al. Effects of acarbose on cardiovascular and diabetes outcomes in patients with coronary heart disease and impaired glucose tolerance (ACE): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017. pii: S2213-8587(17)30309-1.
24. Holman RR, et al. Effects of once-weekly exenatide on cardiovascular outcomes in Type 2 diabetes. N Engl J Med. 2017;377(13):1228-39.
25. Zinman B, et al. Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia. 2017. doi: 10.1007/s00125-017-4423-z.
26. Frontoni S, et al. Glucose variability: an emerging target for the treatment of diabetes mellitus. Diabetes Res Clin Pract. 2013;102(2):86-95.
27. Heise T, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes. 2004;53(6):1614-20.
28. Wanner C, et al. Empagliflozin and progression of kidney disease in Type 2 diabetes. N Engl J Med. 2016;375(4):323-34.
29. Watts NB, et al. Effects of canagliflozin on fracture risk in patients With Type 2 diabetes mellitus. J Clin Endocrinol Metab. 2016;101(1):157-66.
30. FDA Drug Safety Communication. FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density; 2015.
31. FDA Drug Safety Communications. FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). Silver Spring: FDA Drug Safety Communications; 2016.
32. Fadini GP, Avogaro A. SGTL2 inhibitors and amputations in the US FDA adverse event reporting system. Lancet Diabetes Endocrinol. 2017;5(9):680-1.
33. Agency EM. SGLT-2 inhibitors: information on potential risk of toe amputation to be included in prescribing information; 2017.
34. Kosiborod M, et al. Lower risk of heart failure and death in patients initiated on SGLT-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study. Circulation. 2017;136(3):249-59.
35. Wu JH, et al. Effects of sodium-glucose cotransporter-2 inhibitors on cardiovascular events, death, and major safety outcomes in adults with type 2 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2016;4(5):411-9.
36. Standl E, et al. On the potential of acarbose to reduce cardiovascular disease. Cardiovasc Diabetol. 2014;13:81.
37. Ponikowski P, et al. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Rev Esp Cardiol (Engl Ed). 2016;69(12):1167.
38. Rydén L, et al. Corrections needed to 2016 ESC guideline and AHA scientific statement on heart failure. Lancet Diabetes Endocrinol. 2017;5(5):325-6.
39. Griffin SJ, Leaver JK, Irving GJ. Impact of metformin on cardiovascular disease: a meta-analysis of randomised trials among people with type 2 diabetes. Diabetologia. 2017. doi: 10.1007/s00125-017-4337-9.
40. Petrie JR, et al. Cardiovascular and metabolic effects of metformin in patients with type 1 diabetes (REMOVAL): a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017;5(8):597-609.
41. Standl E. Metformin in type 1 diabetes. Lancet Diabetes Endocrinol. 2017;5:567-9.
42. Vaccaro O, et al. The TOSCA.IT trial: a study designed to evaluate the effect of pioglitazone versus sulfonylureas on cardiovascular disease in type 2 diabetes. Diabetes Care. 2012;35(12):e82.
43. Vaccaro O, et al. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial. Lancet Diabetes Endocrinol. 2017;35(12):e82.
44. Dormandy JA, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366(9493):1279-89.
45. Ridker PM, et al. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med. 2017;377(12):1119-31.
46. Standl E, et al. Integration of recent evidence into management of patients with atherosclerotic cardiovascular disease and type 2 diabetes. Lancet Diabetes Endocrinol. 2017;5(5):391-402.
47. Leiter LA, et al. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015;38(6):1145-53.
48. Zannad F, et al. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015;385(9982):2067-76.
49. Marso SP, et al. Liraglutide and cardiovascular outcomes in Type 2 diabetes. N Engl J Med. 2016;375(4):311-22
50. Marso SP, et al. Semaglutide and cardiovascular outcomes in patients with Type 2 diabetes. N Engl J Med. 2016;375(19):1834-44.