Integration of recent evidence into management of patients with atherosclerotic cardiovascular disease and type 2 diabetes

The Lancet Diabetes and Endocrinology

Volumn 5, Issue 5, 2017, Pages 391-402

  Standl, Eberhard ^a   Schnell, Oliver ^a   McGuire, Darren K ^b   Ceriello, Antonio ^c,d,e   Rydén, Lars ^f  

^a INSTITUTE OF EPIDEMIOLOGY   (Germany)

^b UNIVERSITY OF TEXAS AT DALLAS   (United States)

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

^d INSTITUTO DE SALUD CARLOS III   (Spain)

^e IRCCS MULTIMEDICA   (Italy)

^f KAROLINSKA INSTITUTE   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ALIROCUMAB; ALOGLIPTIN; CANAGLIFLOZIN; DAPAGLIFLOZIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EMPAGLIFLOZIN; EVOLOCUMAB; EZETIMIBE; HEMOGLOBIN A1C; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN GLARGINE; LIRAGLUTIDE; LIXISENATIDE; PROPROTEIN CONVERTASE 9; PROTEIN INHIBITOR; SAXAGLIPTIN; SEMAGLUTIDE; SITAGLIPTIN; SUBTILISIN; ANTIDIABETIC AGENT; HYPOCHOLESTEROLEMIC AGENT;

CARDIOVASCULAR RISK; CLINICAL TRIAL (TOPIC); CORONARY ARTERY ATHEROSCLEROSIS; DYSLIPIDEMIA; GLUCOSURIA; HEART FAILURE; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; META ANALYSIS (TOPIC); NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS CANCER; POSTPRANDIAL STATE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETINOPATHY; REVIEW; SIGNAL TRANSDUCTION; WEIGHT REDUCTION; ATHEROSCLEROSIS; COMPLICATION;

ANTICHOLESTEREMIC AGENTS; ATHEROSCLEROSIS; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS;

EID: 85010840368     PISSN: 22138587     EISSN: 22138595     Source Type: Journal    
DOI: 10.1016/S2213-8587(17)30033-5     Document Type: Review

References (77)

1. 1 Inzucchi, SE, Bergenstal, RM, Buse, JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 38 (2015), 140–149.
2. 2 Piepoli, MF, Hoes, AW, Agewall, S, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: the Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts): developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur J Prev Cardiol 23 (2016), NP1–N96.
3. 3 Ponikowski, P, Voors, AA, Anker, SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 37 (2016), 2129–2200.
4. 4 Ryden, L, Grant, PJ, Anker, SD, et al. ESC guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the task force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J 34 (2013), 3035–3087.
5. 5 Fox, CS, Golden, SH, Anderson, C, et al. Update on prevention of cardiovascular disease in adults with type 2 diabetes mellitus in light of recent evidence: a scientific statement from the American Heart Association and the American Diabetes Association. Diabetes Care 38 (2015), 1777–1803.
6. 6 Tancredi, M, Rosengren, A, Svensson, AM, et al. Excess mortality among persons with type 2 diabetes. N Engl J Med 373 (2015), 1720–1732.
7. 7 Gregg, EW, Sattar, N, Ali, MK, The changing face of diabetes complications. Lancet Diabetes Endocrinol 4 (2016), 537–547.
8. 8 Beckman, JA, Creager, MA, Vascular complications of diabetes. Circ Res 118 (2016), 1771–1785.
9. 9 Gitt, A, Bramlage, P, Towae, F, et al. Newly diagnosed diabetes and prediabetes in patients after acute myocardial infarction predicts adverse outcomes during a three-year follow-up: results of the SWEETHEART registry. J Am Coll Cardiol, 61, 2013, E176.
10. 10 Tillberg, M, (eds.) Swedeheart Annual Report 2015, 2015, Tomas Jernberg, Stockholm.
11. 11 McGuire, DK, Inzucchi, SE, New drugs for the treatment of diabetes mellitus: part I: thiazolidinediones and their evolving cardiovascular implications. Circulation 117 (2008), 440–449.
12. 12 Nissen, SE, Wolski, K, Topol, EJ, Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 294 (2005), 2581–2586.
13. 13 Page, RL 2nd, O'Bryant, CL, Cheng, D, et al. Drugs that may cause or exacerbate heart failure: a scientific statement from the American Heart Association. Circulation 134 (2016), e32–e69.
14. 14 Ryden, L, Standl, E, Bartnik, M, et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 28 (2007), 88–136.
15. 15 Yancy, CW, Jessup, M, Bozkurt, B, et al. 2013 ACCF/antihyperglycaemic agent guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 62 (2013), e147–e239.
16. 16 US Food and Drug Administration. Guidance for industry: diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes, 2008, US Department of Health and Human Services, Food and Drug Administration, and Center for Drug Evaluation and Research http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf (accessed Dec 14, 2016).
17. 17 European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129256.pdf, May 14, 2012 (accessed Jan 10, 2016).
18. 18 Holman, RR, Sourij, H, Califf, RM, Cardiovascular outcome trials of glucose-lowering drugs or strategies in type 2 diabetes. Lancet 383 (2014), 2008–2017.
19. 19 Goldner, MG, Knatterud, GL, Prout, TE, Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. 3. Clinical implications of UGDP results. JAMA 218 (1971), 1400–1410.
20. 20 Dormandy, JA, Charbonnel, B, Eckland, DJ, 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 366 (2005), 1279–1289.
21. 21 Duckworth, W, Abraira, C, Moritz, T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 360 (2009), 129–139.
22. 22 UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352 (1998), 837–853.
23. 23 Home, PD, Pocock, SJ, Beck-Nielsen, H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 373 (2009), 2125–2135.
24. 24 Malmberg, K, Ryden, L, Efendic, S, et al. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol 26 (1995), 57–65.
25. 25 Malmberg, K, Ryden, L, Wedel, H, et al. Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction (DIGAMI 2): effects on mortality and morbidity. Eur Heart J 26 (2005), 650–661.
26. 26 Patel, A, MacMahon, S, Chalmers, J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 358 (2008), 2560–2572.
27. 27 Gerstein, HC, Miller, ME, Byington, RP, et al., for the Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 358 (2008), 2545–2559.
28. 28 Cannon, CP, Blazing, MA, Giugliano, RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 372 (2015), 2387–2397.
29. 29 Robinson, JG, Farnier, M, Krempf, M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 372 (2015), 1489–1499.
30. 30 Sabatine, MS, Giugliano, RP, Wiviott, SD, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med 372 (2015), 1500–1509.
31. 31 Marso, SP, Bain, SC, Consoli, A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 375 (2016), 1834–1844.
32. 32 Marso, SP, Daniels, GH, Brown-Frandsen, K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 375 (2016), 311–322.
33. 33 Zinman, B, Wanner, C, Lachin, JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 373 (2015), 2117–2128.
34. 34 Nauck, M, Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors. Diabetes Obes Metab 18 (2016), 203–216.
35. 35 The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329 (1993), 977–986.
36. 36 Gallo, LA, Wright, EM, Vallon, V, Probing SGLT2 as a therapeutic target for diabetes: basic physiology and consequences. Diab Vasc Dis Res 12 (2015), 78–89.
37. 37 DeFronzo, RA, Hompesch, M, Kasichayanula, S, et al. Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes. Diabetes Care 36 (2013), 3169–3176.
38. 38 Cherney, DZ, Perkins, BA, Soleymanlou, N, et al. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation 129 (2014), 587–597.
39. 39 Heerspink, HJ, Perkins, BA, Fitchett, DH, Husain, M, Cherney, DZ, Sodium glucose cotransporter 2 inhibitors in the treatment of diabetes: cardiovascular and kidney effects, potential mechanisms and clinical applications. Circulation 134 (2016), 752–772.
40. 40 Wanner, C, Inzucchi, SE, Lachin, JM, et al. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med 375 (2016), 323–334.
41. 41 US Food and Drug Administration. Canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR): drug safety communication—strengthened kidney warnings. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm, June 14, 2016 (accessed Oct 10, 2016).
42. 42 Pfeffer, MA, Claggett, B, Diaz, R, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med 373 (2015), 2247–2257.
43. 43 Quianzon, C, Shomali, ME, Lixisenatide—once-daily glucagon-like peptide-1 receptor agonist in the management of type 2 diabetes. European Endocrinol 8 (2012), 12–17.
44. 44 Margulies, KB, Hernandez, AF, Redfield, MM, et al. Effects of liraglutide on clinical stability among patients with advanced heart failure and reduced ejection fraction: a randomized clinical trial. JAMA 316 (2016), 500–508.
45. 45 Gerstein, HC, Bosch, J, Dagenais, GR, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 367 (2012), 319–328.
46. 46 Scirica, BM, Bhatt, DL, Braunwald, E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 369 (2013), 1317–1326.
47. 47 White, WB, Cannon, CP, Heller, SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 369 (2013), 1327–1335.
48. 48 Green, JB, Bethel, MA, Armstrong, PW, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med 373 (2015), 232–242.
49. 49 Nathan, DM, Cleary, PA, Backlund, JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 353 (2005), 2643–2653.
50. 50 Ritsinger, V, Malmberg, K, Martensson, A, Ryden, L, Wedel, H, Norhammar, A, Intensified insulin-based glycaemic control after myocardial infarction: mortality during 20 year follow-up of the randomised Diabetes Mellitus Insulin Glucose Infusion in Acute Myocardial Infarction (DIGAMI 1) trial. Lancet Diabetes Endocrinol 2 (2014), 627–633.
51. 51 Monami, M, Dicembrini, I, Mannucci, E, Dipeptidyl peptidase-4 inhibitors and heart failure: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis 24 (2014), 689–697.
52. 52 Scirica, BM, Braunwald, E, Raz, I, et al. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation 130 (2014), 1579–1588.
53. 53 Zannad, F, Cannon, CP, Cushman, WC, 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 385 (2015), 2067–2076.
54. 54 McGuire, DK, Van de Werf, F, Armstrong, PW, et al. Association between sitagliptin use and heart failure hospitalization and related outcomes in type 2 diabetes mellitus: secondary analysis of a randomized clinical trial. JAMA Cardiol 1 (2016), 126–135.
55. 55 US Food and Drug Administration. Diabetes medications containing saxagliptin and alogliptin: drug safety communication—risk of heart failure. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm, April 5, 2016 (accessed April 13, 2016).
56. 56 Ekstrom, N, Svensson, AM, Miftaraj, M, et al. Cardiovascular safety of glucose-lowering agents as add-on medication to metformin treatment in type 2 diabetes: report from the Swedish National Diabetes Register. Diabetes Obes Metab 18 (2016), 990–998.
57. 57 Fadini, GP, Avogaro, A, Degli Esposti, L, et al. Risk of hospitalization for heart failure in patients with type 2 diabetes newly treated with DPP-4 inhibitors or other oral glucose-lowering medications: a retrospective registry study on 127,555 patients from the Nationwide OsMed Health-DB Database. Eur Heart J 36 (2015), 2454–2462.
58. 58 Filion, KB, Azoulay, L, Platt, RW, et al. A multicenter observational study of incretin-based drugs and heart failure. N Engl J Med 374 (2016), 1145–1154.
59. 59 Standl, E, Statins and beyond: concurrent strategies for prevention of cardiovascular disease in patients with type 2 diabetes. Diab Vasc Dis Res 10 (2013), 99–114.
60. 60 Roth, EM, McKenney, JM, Hanotin, C, Asset, G, Stein, EA, Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med 367 (2012), 1891–1900.
61. 61 Stein, EA, Gipe, D, Bergeron, J, et al. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial. Lancet 380 (2012), 29–36.
62. 62 Cholesterol Treatment Trialists' Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials. Lancet 376 (2010), 1670–1681.
63. 63 Cohen, JC, Boerwinkle, E, Mosley, TH Jr, Hobbs, HH, Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med 354 (2006), 1264–1272.
64. 64 Sattar, N, McLaren, J, Kristensen, SL, Preiss, D, McMurray, JJ, SGLT2 Inhibition and cardiovascular events: why did EMPA-REG outcomes surprise and what were the likely mechanisms?. Diabetologia 59 (2016), 1333–1339.
65. 65 Wright, JT Jr, Williamson, JD, Whelton, PK, et al. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med 373 (2015), 2103–2116.
66. 66 Kjeldsen, SE, Lund-Johansen, P, Nilsson, PM, Mancia, G, Unattended blood pressure measurements in the Systolic Blood Pressure Intervention Trial: implications for entry and achieved blood pressure values compared with other trials. Hypertension 67 (2016), 808–812.
67. 67 Bakris, GL, The implications of blood pressure measurement methods on treatment targets for blood pressure. Circulation 134 (2016), 904–905.
68. 68 Standl, E, Erbach, M, Hanefeld, M, Schnell, O, Stratmann, B, Tschoepe, D, Clinical features and treatment of coronary heart disease in diabetes. DeFronzo, RA, Ferrannini, E, Zimmet, P, Alberti, G, (eds.) International textbook of diabetes mellitus, 2015, Wiley-Blackwell, Oxford, 1064–1078.
69. 69 Tkac, I, Raz, I, Combined analysis of three large interventional trials with gliptins indicates increased incidence of acute pancreatitis in patients with type 2 diabetes. Diabetes Care, 2016, 10.2337/dc15-1707 published online Sept 22.
70. 70 Kernan, WN, Viscoli, CM, Furie, KL, et al. Pioglitazone after ischemic stroke or transient ischemic attack. N Engl J Med 374 (2016), 1321–1331.
71. 71 Writing, C, Lloyd-Jones, DM, Morris, PB, et al. 2016 ACC expert consensus decision pathway on the role of non-statin therapies for ldl-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Task Force on clinical expert consensus documents. J Am Coll Cardiol 68 (2016), 92–125.
72. 72 Catapano, AL, Graham, I, De Backer, G, et al. 2016 ESC/EAS guidelines for the management of dyslipidaemias: the task force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J 37 (2016), 2999–3058.
73. 73 Standl, E, Schnell, O, McGuire, DK, Heart failure considerations of antihyperglycemic medications for type 2 diabetes. Circ Res 118 (2016), 1830–1843.
74. 74 Ceriello, A, Gallo, M, Candido, R, et al. Personalized therapy algorithms for type 2 diabetes: a phenotype-based approach. Pharmacogenomics Pers Med 7 (2014), 129–136.
75. 75 Tuttle, KR, Bakris, GL, Bilous, RW, et al. Diabetic kidney disease: a report from an ADA Consensus Conference. Diabetes Care 37 (2014), 2864–2883.
76. 76 McFarlane, P GR, MacCallum, L, Senior, P, on behalf of the Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. November 2016 interim update to the guidelines, update to the pharmacologic management of type 2 diabetes. www.guidelines.diabetes.ca/update, 2016 (accessed Nov 23, 2016).
77. 77 Guideline Development Group. Clinical practice guideline on management of patients with diabetes and chronic kidney disease stage 3b or higher (eGFR <45 mL/min). Nephrol Dial Transplant 30:suppl 2 (2015), 1–142.