Cardiovascular Outcomes of New Medications for Type 2 Diabetes

Diabetes Technology and Therapeutics

Volumn 18, Issue 12, 2016, Pages 749-758

  Trujillo, Jennifer M ^a   Wettergreen, Sara A ^b   Nuffer, Wesley A ^a   Ellis, Samuel L ^a   McDermott, Michael T ^a,c  

^a UNIVERSITY OF COLORADO   (United States)

^b University of North Texas System College of Pharmacy   (United States)

^c UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

Author keywords

Cardiovascular disease; Medications; Type 2 diabetes

Indexed keywords

ALBIGLUTIDE; ALOGLIPTIN; ANTIDIABETIC AGENT; CANAGLIFLOZIN; DAPAGLIFLOZIN; DULAGLUTIDE; EMPAGLIFLOZIN; EXENDIN 4; INSULIN DEGLUDEC; LINAGLIPTIN; LIRAGLUTIDE; LIXISENATIDE; SEMAGLUTIDE; SITAGLIPTIN;

CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CONTROLLED CLINICAL TRIAL (TOPIC); DIABETIC PATIENT; HUMAN; META ANALYSIS (TOPIC); NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SAFETY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; CARDIOVASCULAR DISEASES; CHEMICALLY INDUCED; COMPLICATION; DIABETES MELLITUS, TYPE 2;

CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS;

EID: 85007019116     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2016.0295     Document Type: Review

References (48)

1. International Diabetes Federation: IDF Diabetes, 7th ed. Brussels, Belgium: International Diabetes Federation, 2015. www.diabetesatlas.org (accessed June 20, 2016).
2. Centers for Disease Control and Prevention: National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US De-partment of Health and Human Services, 2014.
3. Gregg EW, Li Y, Wang J, et al.: Changes in diabetes-related complications in the United States, 1990-2010. N Engl J Med 2014;370:1514-1523.
4. UK Prospective Diabetes Study (UKPDS) 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 1998; 352:837-853.
5. UK Prospective Diabetes Study (UKPDS) Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854-865.
6. Gerstein HC, Miller ME, Byington RP, et al.; Action to control cardiovascular risk in Diabetes Study Group: Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-2559.
7. Patel A, MacMahon S, Chalmers J, et al.; ADVANCE Collaborative Group: Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560-2572.
8. Duckworth W, Abraira C, Moritz T, et al.; VADT Investigators: Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 2009;360: 129-139.
9. Holman RR, Paul SK, Bethel MA, et al.: 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577-1588.
10. Nissen SE, Wolski K: Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356:2457-2471.
11. [Erratum, N Engl J Med 2007;357:100.]
12. Hiatt WR, Kaul SK, Smith RJ: The CV safety of diabetes drugs-insights from the rosiglitazone experience. N Engl J Med 2013;369:1285-1287.
13. Home PD, Pocock SJ, Beck-Nielsen H, et al.: Rosiglitazone evaluate for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicenter, randomized, open-label trial. Lancet 2009;373:2125-2135.
14. U.S. Food and Drug Administration: Drug Safety Communication: FDA Requires Removal of Some Prescribing and Dispensing Restrictions for Rosiglitazone-Containing Medicines. www.fda.gov/Drugs/DrugSafety/ucm376389.htm (accessed October 1, 2016).
15. U.S. Food and Drug Administration: Guidance for Industry: Diabetes Mellitus-Evaluating CV Risk in New Anti-diabetic Therapies to Treat Type 2 Diabetes. Silver Spring, MD: Department of Health and Human Services, Center for Drug Evaluation and Research, 2008. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf (accessed July 22, 2016).
16. The ORIGIN Trial Investigators: Basal insulin and CV and other outcomes in dysglycemia. New Engl J Med 2012;367: 319-328.
17. Dormandy JA, Charbonnel B, Eckland DJA, et al.: Secondary prevention of macrovascular events in patients with T2D in the PROactive trial (prospective pioglitazone clinical trial in macrovascular events): a randomized controlled trial. Lancet 2005;366:1279-1289.
18. Kernan WN, Viscoli CM, Furie KL, et al.: Pioglitazone after ischemic stroke or transient ischemic attack. N Engl J Med 2016;374:1321-1331.
19. Ussher JR, Drucker DJ: Cardiovascular actions of incretin-based therapies. Circ Res 2014;114:1788-1803.
20. Scirica BM, Bhatt DL, Braunwald E, et al.: Saxagliptin and CV outcomes in patients with T2D mellitus. N Engl J Med 2013;369:1317-1326.
21. White WB, Cannon CP, Heller SR, et al.: Alogliptin after acute coronary syndrome in patients with T2D. N Engl J Med 2013;369:1327-1335.
22. Green JB, Bethel MA, Armstrong PW, et al.: Effect of sitagliptin on CV outcomes in T2D. N Engl J Med 2015; 373:232-242.
23. Zannad F, Cannon CP, Cushman WC, et al.: Heart failure and mortality outcomes in patients with T2D taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet 2015;385:2067-2076.
24. White WB, Kupfer S, Zannad F, et al.: Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes from the EXAMINE trial. Diabetes Care 2016:dc160303.
25. 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 2015;38:140-149.
26. Cherney DZ, Perkins BA, Soleymanlou N, et al.: The effects of empagliflozin on arterial stiffness and heart rate variability in subjects with uncomplicated type 1 diabetes mellitus. Cardiovasc Diabetol 2014;13:28.
27. Yale JF, Bakris J, Cariou B, et al.: Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diab Obes Metab 2013;15:463-473.
28. Zinman B, Wanner C, Lachin JM, et al.: Empagliflozin, CV outcomes, and mortality in T2D. N Engl J Med 2015;373: 2117-2128.
29. Drucker DJ: The CV biology of glucagon-like peptide-1. Cell Metabolism 2016. DOI:10.1016/j.cmet.2016.06.009
30. Pfeffeer MA, Claggett B, Diaz R, et al.: Lixisenatide in patients with T2D and acute coronary syndrome. N Engl J Med 2015;373:2247-2257.
31. Marso S, Daniels G, Brown-Frandsen K, et al.: Liraglutide and cardiovascular outcomes in type 2 diabetes (LEADER). N Engl J Med 2016. DOI:10.1056/NEJMoa1603827
32. Marso SP, Bain SC, Consoli A, et al.: Semaglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016. DOI:10:1056/NEJMoa1607141
33. Intarcia Therapeutics, Inc.: Press Release: Intarcia Announces Successful CV Safety Results in Phase 3 FREEDOM-CVO Trial for ITCA 650, an Investigational Therapy for T2D. www.intarcia.com/media/press-releases/2016-may-6-CV-safety.html (accessed June 24, 2016).
34. Kundu A, Sardar P, Ghosh S, et al.: Risk of heart failure with dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: a meta-analysis of randomized con-trolled trials. Int J Cardiol 2016;212:203-205.
35. Kongwatcharapong J, Dilokthornsakul P, Nathisuwan S, et al.: Effect of dipeptidyl peptidase-4 inhibitors on heart failure: a meta-analysis of randomized clinical trials. Int J Cardiol 2016;211:88-95.
36. Li L, Li S, Deng K, et al.: Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: systematic review and meta-analysis of randomised and observational studies. BMJ 2016;352:i610.
37. Ou X, O'Leary HA, Broxmeyer HE: Implications of DPP4 modification of proteins that regulate stem/progenitor and more mature cell types. Blood 2013;122:161-169.
38. Deacon CF: Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diabetes Obes Metab 2011;13:7-18.
39. Pitt B, White H, Nicolau J, et al.: Eplerenone reduces mortality 30 days after randomization following acute myocar-dial infarction in patients with left ventricular systolic dysfunction and heart failure. J Am Coll Cardiol 2005;46: 425-431.
40. Pitt B, Zannad F, Remme WJ, et al.: The effect of spir-onolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999;341:709-717.
41. Mudaliar S, Alloju S, Henry RR: Can a shift in fuel energetics explain the beneficial cardiorenal outcomes in the EMPA-REG OUTCOME trial? A unifying hypothesis. Diabetes Care 2016;39:1115-1122.
42. Ferrannini E, Mark M, Mayoux E: CV protection in the EMPA-REG OUTCOME trial: a "thrifty substrate" hypothesis. Diabetes Care 2016;39:1108-1114.
43. U.S. Food and Drug Administration Briefing Document. Endocrine and Metabolic Drug Advisory Committee Meeting, June 28, 2016. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Endocrinologicand MetabolicDrugsAdvisoryCommittee/UCM508422.pdf (accessed August 3, 2016).
44. Ismail-Beigi F, Craven T, Banerji MA, et al.; for the ACCORD Trial Group: Effect of intensive treatment of hy-perglycemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomized trial. Lancet 2010; 376;419-430.
45. Ohkubo Y, Kishikawa H, Araki E, et al.: Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 1995;28:103-117.
46. Shichiri M, Kishikawa H, Ohkubo Y, Wake N: Long-term results of the Kumamoto study on optimal diabetes control in type 2 diabetic patients. Diabetes Care 2000;23(Suppl 2): B21-B29.
47. American Diabetes Association: Standards of medical care in diabetes 2016. Cardiovascular disease and risk management. Diabetes Care 2016;39(Suppl 1):S60-S71.
48. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee: Pharmacologic Management of Type 2 Diabetes-2016 Interim Update. http://guidelines.diabetes.ca/executivesummary/ch13-2016 (accessed October 2, 2016).