Cardiovascular outcome trials of glucose-lowering drugs or strategies in type 2 diabetes

The Lancet

Volumn 383, Issue 9933, 2014, Pages 2008-2017

  Holman, Rury R ^a   Sourij, Harald ^b   Califf, Robert M ^c  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b MEDICAL UNIVERSITY OF GRAZ   (Austria)

^c DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT; BIGUANIDE; CANAGLIFLOZIN; DAPAGLIFLOZIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; DULAGLUTIDE; EMPAGLIFLOZIN; ERTUGLIFLOZIN; EXENDIN 4; GLIMEPIRIDE; GLUCOSE; INSULIN; INSULIN DEGLUDEC; INSULIN GLARGINE; LINAGLIPTIN; LIRAGLUTIDE; LIXISENATIDE; LONG ACTING INSULIN; METFORMIN; OMARIGLIPTIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SAXAGLIPTIN; SEMAGLUTIDE; SITAGLIPTIN; SULFONYLUREA; HEMOGLOBIN A1C;

ACUTE HEART INFARCTION; ARTICLE; BODY WEIGHT; CARDIOTOXICITY; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CLINICAL PRACTICE; DRUG APPROVAL; DRUG SAFETY; ELECTRONIC MEDICAL RECORD; FOLLOW UP; GLUCOSE BLOOD LEVEL; HEALTH CARE DELIVERY; HEALTH PROGRAM; HEART PROTECTION; HOSPITALIZATION; HUMAN; HYPOGLYCEMIA; INSULIN TREATMENT; LONG TERM CARE; MEDICATION COMPLIANCE; MICROANGIOPATHY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT CARE; PHENOTYPE; POLYPHARMACY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK REDUCTION; SYSTEMATIC REVIEW (TOPIC); TREATMENT OUTCOME; WEIGHT GAIN; WEIGHT REDUCTION; FOOD AND DRUG ADMINISTRATION; RISK FACTOR;

DIABETES MELLITUS, TYPE 2; DIABETIC ANGIOPATHIES; FOLLOW-UP STUDIES; FORECASTING; HUMANS; HYPOGLYCEMIC AGENTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84901768284     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)60794-7     Document Type: Review

References (58)

1. International Diabetes Federation. Diabetes Atlas. http://www.idf.org/ diabetesatlas (accessed Feb 23, 2014).
2. Seshasai SR, Kaptoge S, Thompson A, et al, and the Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med 2011; 364: 829-41.
3. 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: 837-53.
4. Nathan DM, Cleary PA, Backlund JY, et al, and the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005; 353: 2643-53.
5. Siperstein MD, Unger RH, Madison LL. Studies of muscle capillary basement membranes in normal subjects, diabetic, and prediabetic patients. J Clin Invest 1968; 47: 1973-99.
6. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: 703-13.
7. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory-Information/Guidances/ucm071627.pdf (accessed Feb 23, 2014).
8. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. May 2012. http://www.ema.europa.eu/docs/en-GB/document-library/Scientifi c-guideline/2012/06/WC500129256.pdf (accessed Feb 23, 2014).
9. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457-71.
10. Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med 2010; 170: 1191-201.
11. Bethel MA, Sourij H. Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice. Curr Cardiol Rep 2012; 14: 59-69.
12. 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: 854-65.
13. Malmberg K, Rydén L, Wedel H, et al, and the DIGAMI 2 Investigators. 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 2005; 26: 650-61.
14. Dormandy JA, Charbonnel B, Eckland DJ, et al, and the PROactive investigators. 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: 1279-89.
15. Patel A, MacMahon S, Chalmers J, et al, and the ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008; 358: 2560-72.
16. Gerstein HC, Miller ME, Byington RP, et al, and the Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008; 358: 2545-59.
17. Raz I, Wilson PW, Strojek K, et al. Effects of prandial versus fasting glycemia on cardiovascular outcomes in type 2 diabetes: the HEART2D trial. Diabetes Care 2009; 32: 381-86.
18. Duckworth W, Abraira C, Moritz T, et al, and the VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 2009; 360: 129-39.
19. Home PD, Pocock SJ, Beck-Nielsen H, et al, and the RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009; 373: 2125-35.
20. Frye RL, August P, Brooks MM, et al, and the BARI 2D Study Group. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med 2009; 360: 2503-15.
21. Griffi n SJ, Borch-Johnsen K, Davies MJ, et al. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet 2011; 378: 156-67.
22. Gerstein HC, Bosch J, Dagenais GR, et al, and the ORIGIN Trial Investigators. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012; 367: 319-28.
23. Scirica BM, Bhatt DL, Braunwald E, et al, and the SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013; 369: 1317-26.
24. White WB, Cannon CP, Heller SR, et al, and the EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013; 369: 1327-35.
25. Wing RR, Bolin P, Brancati FL, et al, and the Look AHEAD Research Group. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med 2013; 369: 145-54.
26. Meinert CL, Knatterud GL, Prout TE, Klimt CR. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes 1970; 19 (suppl): 789-830.
27. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359: 1577-89.
28. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012; 55: 1577-96.
29. Malmberg K. Prospective randomised study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. DIGAMI (Diabetes Mellitus, Insulin Glucose Infusion in Acute Myocardial Infarction) Study Group. BMJ 1997; 314: 1512-15.
30. Turnbull FM, Abraira C, Anderson RJ, et al, and the Control Group. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia 2009; 52: 2288-98.
31. Riddle MC, Ambrosius WT, Brillon DJ, et al, and the Action to Control Cardiovascular Risk in Diabetes Investigators. Epidemiologic relationships between A1C and all-cause mortality during a median 3.4-year follow-up of glycemic treatment in the ACCORD trial. Diabetes Care 2010; 33: 983-90.
32. Bonds DE, Miller ME, Bergenstal RM, et al. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ 2010; 340: b4909.
33. Zoungas S, Patel A, Chalmers J, et al, and the ADVANCE Collaborative Group. Severe hypoglycemia and risks of vascular events and death. N Engl J Med 2010; 363: 1410-18.
34. Mellbin LG, Rydén L, Riddle MC, et al, and the ORIGIN Trial Investigators. Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial. Eur Heart J 2013; 34: 3137-44.
35. Ferwana M, Firwana B, Hasan R, et al. Pioglitazone and risk of bladder cancer: a meta-analysis of controlled studies. Diabet Med 2013; 30: 1026-32.
36. Dormandy J, Bhattacharya M, van Troostenburg de Bruyn AR, investigators PROactive. Safety and tolerability of pioglitazone in high-risk patients with type 2 diabetes: an overview of data from PROactive. Drug Saf 2009; 32: 187-202.
37. US Department of Health and Human Services, Food and Drug Administration. Briefi ng Document: Readjudication of the rosiglitazone evaluated for cardiovascular outcomes and regulation of glycemia in diabetes trial (RECORD). Joint Meeting of the Endocrinologic and metabolic drugs advisory committee and the drug safety and risk management advisory committee, June 5-6, 2013. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/ drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm354859.pdf (accessed Feb 23, 2014).
38. Punthakee Z, Bosch J, Dagenais G, et al, and the TIDE Trial Investigators. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial. Diabetologia 2012; 55: 36-45.
39. US Department of Health and Human Services, Food and Drug Administration. FDA press release: FDA requires removal of certain restrictions on the diabetes drug Avandia. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm376516.htm (accessed Feb 23, 2014).
40. Hemkens LG, Grouven U, Bender R, et al. Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study. Diabetologia 2009; 52: 1732-44.
41. Jonasson JM, Ljung R, Talbäck M, Haglund B, Gudbjörnsdò ttir S, Steineck G. Insulin glargine use and short-term incidence of malignancies-a population-based follow-up study in Sweden. Diabetologia 2009; 52: 1745-54.
42. Frederich R, Alexander JH, Fiedorek FT, et al. A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for type 2 diabetes. Postgrad Med 2010; 122: 16-27.
43. Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis 2010; 20: 224-35.
44. Bethel MA, Sourij H. Positive impact of revised FDA guidance on clinical trial design in diabetes (abstr). Diabetes 2012; 61 (supp 1): A264.
45. Kahn SE, Zinman B, Lachin JM, et al, and the Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care 2008; 31: 845-51.
46. US Department of Health and Human Services, Food and Drug Administration. Summary review Linagliptin. http://www.accessdata.fda.gov/drugsatfda-docs/nda/ 2011/201280Orig1s000SumR.pdf (accessed Feb 23, 2014).
47. Endocrinologic and Metabolic Drug Advisory Committee, Novo Nordisk. Briefi ng document: insulin degludec and insulin degludec/insulin aspart treatment to improve glycemic control in patients with diabetes mellitus. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327017.pdf (accessed Feb 23, 2014).
48. Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012; 367: 1355-60.
49. Cobo E, Stephen S, Elmore M. Withdrawing from the treatment does not mean from the study. Bull World Health Organ 2008; 86: C.
50. Cleland JG, Torp-Pedersen C, Coletta AP, Lammiman MJ. A method to reduce loss to follow-up in clinical trials: informed, withdrawal of consent. Eur J Heart Fail 2004; 6: 1-2.
51. Selby JV, Lipstein SH. PCORI at 3 years - progress, lessons, and plans. N Engl J Med 2014; 370: 592-95.
52. Fröbert O, Lagerqvist B, Olivecrona GK, et al, and the TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013; 369: 1587-97.
53. Hess CN, Rao SV, Kong DF, et al. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am Heart J 2013; 166: 421-28.
54. Lauer MS, D'Agostino RB Sr. The randomized registry trial - the next disruptive technology in clinical research? N Engl J Med 2013; 369: 1579-81.
55. Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther 2009; 86: 97-100.
56. Topol EJ. Individualized medicine from prewomb to tomb. Cell 2014; 157: 241-53.
57. Gallin EK, Bond E, Califf RM, et al. Forging stronger partnerships between academic health centers and patient-driven organizations. Acad Med 2013; 88: 1220-24.
58. Kent DM, Rothwell PM, Ioannidis JP, Altman DG, Hayward RA. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials 2010; 11: 85.