Cardiovascular outcome trials in type 2 diabetes and the sulphonylurea controversy: Rationale for the active-comparator CAROLINA trial

Diabetes and Vascular Disease Research

Volumn 10, Issue 4, 2013, Pages 289-301

  Rosenstock, Julio ^a   Marx, Nikolaus ^b   Kahn, Steven E ^c,d   Zinman, Bernard ^e,f   Kastelein, John J ^g   Lachin, John M ^h   Bluhmki, Erich ⁱ   Patel, Sanjay ^j   Johansen, Odd Erik ⁱ   Woerle, Hans Jürgen ⁱ  

^a DALLAS DIABETES AND ENDOCRINE CENTER AT MEDICAL CITY   (United States)

^b UNIVERSITY HOSPITAL RWTH AACHEN   (Germany)

^c VA PUGET SOUND HEALTH CARE SYSTEM   (United States)

^d UNIVERSITY OF WASHINGTON   (United States)

^e MOUNT SINAI HOSPITAL   (Canada)

^f UNIVERSITY OF TORONTO   (Canada)

^g ACADEMIC MEDICAL CENTER   (Netherlands)

^h GEORGE WASHINGTON UNIVERSITY   (United States)

ⁱ BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^j BOEHRINGER INGELHEIM LTD   (United Kingdom)

more..

Author keywords

cardiovascular disease; dipeptidyl peptidase 4 inhibitor; oral glucose lowering agent; sulphonylurea; Type 2 diabetes mellitus

Indexed keywords

ALOGLIPTIN; CHLORPROPAMIDE; GLIBENCLAMIDE; GLIMEPIRIDE; GLIPIZIDE; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1; HEMOGLOBIN A1C; LINAGLIPTIN; METFORMIN; PIOGLITAZONE; PLACEBO; SAXAGLIPTIN; SITAGLIPTIN; VILDAGLIPTIN;

ADVERSE OUTCOME; ARTERIAL WALL THICKNESS; ATHEROSCLEROSIS; BLOOD CLOT LYSIS; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CLINICAL DECISION MAKING; CLINICAL PRACTICE; COMPARATIVE EFFECTIVENESS; DRUG EFFICACY; ENDOTHELIAL PROGENITOR CELL; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GENERAL PRACTITIONER; GLYCEMIC CONTROL; HEART FUNCTION; HEART INFARCTION; HEART MUSCLE CELL; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INSULIN RELEASE; META ANALYSIS; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PATIENT SAFETY; PHASE 3 CLINICAL TRIAL (TOPIC); PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK FACTOR; SYSTEMATIC REVIEW; UNITED KINGDOM; WEIGHT GAIN;

CARDIOVASCULAR DISEASE; DIPEPTIDYL PEPTIDASE-4 INHIBITOR; ORAL GLUCOSE-LOWERING AGENT; SULPHONYLUREA; TYPE 2 DIABETES MELLITUS;

CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; SULFONYLUREA COMPOUNDS;

EID: 84879324855     PISSN: 14791641     EISSN: 17528984     Source Type: Journal    
DOI: 10.1177/1479164112475102     Document Type: Review

References (64)

1. Huxley R, Barzi F, Woodward M. Excess risk of fatal coronary heart disease associated with diabetes in men and women: meta-analysis of 37 prospective cohort studies. BMJ. 2006 ; 332: 73-78
2. Morrish NJ, Wang SL, Stevens LK, et al. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001 ; 44: S14 - S21
3. Muller WA. Diabetes mellitus - long time survival. J Insur Med. 1998 ; 30: 17-27
4. Dale AC, Vatten LJ, Nilsen TI, et al. Secular decline in mortality from coronary heart disease in adults with diabetes mellitus: cohort study. BMJ. 2008 ; 337: a236
5. Sloan FA, Bethel MA, Ruiz D, et al. The growing burden of diabetes mellitus in the US elderly population. Arch Intern Med. 2008 ; 168: 192-199
6. Giugliano D, Standl E, Vilsbøll T, et al. Is the current therapeutic armamentarium in diabetes enough to control the epidemic and its consequences? What are the current shortcomings?. Acta Diabetol. 2009 ; 46: 173-181
7. Rydén 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. 2007 ; 28: 88-136
8. 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 antidiabetes therapies to treat type 2 diabetes, http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf (2008).
9. Selvin E, Marinopoulos S, Berkenblit G, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med. 2004 ; 141: 421-431
10. Turner RC, Millns H, Neil HA, et al. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom prospective diabetes study (UKPDS: 23). BMJ. 1998 ; 316: 823-828
11. Skyler JS, Bergenstal R, Bonow RO, et al. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA Diabetes Trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care. 2009 ; 32: 187-192
12. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2009 ; 52: 17-30
13. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia 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). Diabetes Care. 2012 ; 35: 1364-1379
14. 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
15. 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: 1577-1589
16. Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 ; 358: 2545-2559
17. 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. 2008 ; 358: 2560-2572
18. Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009 ; 360: 129-139
19. Moritz T, Duckworth W, Abraira C. Veterans Affairs diabetes trial - corrections. N Engl J Med. 2009 ; 361: 1024-1025
20. VIII. Study design, progress and performance. Diabetologia. 1991 ; 34: 877-890
21. https://www.fbo.gov/index?s=opportunity&;mode=form&id= 8da1608d1954148af9d4d18955826fe5&tab=core&-cview=0 (2011, accessed 31 October 2012).
22. ClinicalTrials.gov Identifier: NCT00949286, http://www.clinicaltrials. gov/ct2/show/NCT00949286?term=nct00949286&rank=1 (2009, accessed 31 October 2012).
23. Selvin E, Bolen S, Yeh HC, et al. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med. 2008 ; 168: 2070-2080
24. Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011 ; 154: 602-613
25. Wilcox R, Kupfer S, Erdmann E. Effects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10). Am Heart J. 2008 ; 155: 712-717
26. Mazzone T, Meyer PM, Feinstein SB, et al. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA. 2006 ; 296: 2572-2581
27. Nissen SE, Nicholls SJ, Wolski K, et al. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA. 2008 ; 299: 1561-1573
28. Gerstein HC, Ratner RE, Cannon CP, et al. Effect of rosiglitazone on progression of coronary atherosclerosis in patients with type 2 diabetes mellitus and coronary artery disease: the assessment on the prevention of progression by rosiglitazone on atherosclerosis in diabetes patients with cardiovascular history trial. Circulation. 2010 ; 121: 1176-1187
29. Ye Y, Perez-Polo JR, Aguilar D, et al. The potential effects of anti-diabetes medications on myocardial ischemia-reperfusion injury. Basic Res Cardiol. 2011 ; 106: 925-952
30. Meinert CL, Knatterud GL, Prout TE, et al. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes. 1970 ; 19: 789-830
31. Seltzer HS. A summary of criticisms of the findings and conclusions of the University Group Diabetes Program (UGDP). Diabetes. 1972 ; 21: 976-979
32. Krall RL. Cardiovascular safety of rosiglitazone. Lancet. 2007 ; 369: 1995-1996
33. Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 ; 355: 2427-2443
34. Matthews DR, Dejager S, Ahren B, et al. Vildagliptin add-on to metformin provides similar efficacy and reduced hypoglycaemia risk compared with glimepiride with no weight gain: result from a 2-year study. Diabetes Obes Metab. 2010 ; 11: 780-789
35. Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of mono-therapy in drug-naïve patients with type 2 diabetes. Horm Metab Res. 2009 ; 41: 905-909
36. Seck T, Nauck M, Sheng D, et al. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2 year study. Int J Clin Pract. 2010 ; 64: 562-576
37. Chacra AR, Tan GH, Ravichandran S, et al. Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks. Diab Vasc Dis Res. 2011 ; 8: 150-159
38. Garber A, Henry RR, Ratner R, et al. Liraglutide, a once-daily human glucagon-like peptide 1 analogue, provides sustained improvements in glycaemic control and weight for 2 years as monotherapy compared with glimepiride in patients with type 2 diabetes. Diabetes Obes Metab. 2011 ; 13: 348-356
39. 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. 2009 ; 373: 2125-2135
40. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009 ; 360: 2503-2515
41. Abraira C, Duckworth WC, Moritz T, et al. Glycaemic separation and risk factor control in the Veterans Affairs Diabetes Trial: an interim report. Diabetes Obes Metab. 2009 ; 11: 150-156
42. Calles-Escandon J, Lovato LC, Simons-Morton DG, et al. Effect of intensive compared with standard glycemia treatment strategies on mortality by baseline subgroup characteristics. Diabetes Care. 2010 ; 33: 721-727
43. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998 ; 352: 854-865
44. Johnson JA, Majumdar SR, Simpson SH, et al. Decreased mortality associated with the use of metformin compared with sulfonylurea monotherapy in type 2 diabetes. Diabetes Care. 2002 ; 25: 2244-2248
45. Tzoulaki I, Molokhia M, Curcin V, et al. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database. BMJ. 2009 ; 339: b4731
46. Schramm TK, Gislason GH, Vaag H, et al. Mortality and cardiovascular risk associated with different insulin secretagogues compared with metformin in type 2 diabetes, with or without a previous myocardial infarction: a nationwide study. Eur Heart J. 2011 ; 32: 1900-1908
47. Evans JM, Ogston SA, Emslie-Smith A, et al. Risk of mortality and adverse cardiovascular outcomes in type 2 diabetes: a comparison of patients treated with sulfonylureas and metformin. Diabetologia. 2006 ; 49: 930-936
48. Rao AD, Kuhadiya N, Reynolds K, et al. Is the combination of sulfonylureas and metformin associated with an increased risk of cardiovascular disease or all-cause mortality?: a meta-analysis of observational studies. Diabetes Care. 2008 ; 31: 1672-1678
49. Klamann A, Sarfert P, Launhardt V, et al. Myocardial infarction in diabetes vs non-diabetes subjects - survival and infarct size following therapy with sulfonylureas (glibenclamide). Eur Heart J. 2000 ; 21: 220-229
50. Zeller M, Danchin N, Simon D, et al. Impact of type of preadmission sulfonylureas on mortality and cardiovascular outcomes in diabetes patients with acute myocardial infarction. J Clin Endocrinol Metab. 2010 ; 95: 4993-5002
51. European Medicines Agency (EMA). Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. CPMP/EWP/1080/00 Rev. 1, http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2012/06/WC500129256.pdf (2012, accessed 19 July 2012).
52. Ussher RJ, Drucker DJ. Cardiovascular biology of the incretin system. Endocr Rev. 2012 ; 33: 187-215
53. Hanefeld M, Herman GA, Wu M, et al. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr Med Res Opin. 2007 ; 23: 1329-1339
54. Aschner PJ. The role for saxagliptin within the management of type 2 diabetes mellitus: an update from the 2010 European Association for the Study of Diabetes (EASD) 46th annual meeting and the American Diabetes Association (ADA) 70th scientific session. Diabetol Metab Syndr. 2010 ; 2: 69
55. Blech S, Ludwig-Schwellinger E, Grafe-Mody EU, et al. The metabolism and disposition of the oral dipeptidyl peptidase-4 inhibitor, linagliptin, in humans. Drug Metab Dispos. 2010 ; 38: 667-678
56. Keating GM. Vildagliptin: a review of its use in type 2 diabetes mellitus. Drugs. 2010 ; 70: 2089-2112
57. Gallwitz B. The evolving place of incretin-based therapies in type 2 diabetes. Pediatr Nephrol. 2010 ; 25: 1207-1217
58. Johansen OE, Neubacher D, Von Eynatten M, et al. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 ; 11: 3
59. 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
60. Williams-Herman D, Engel SS, Round E, et al. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord. 2010 ; 10: 7
61. Schweizer A, Dejager S, Foley JE, et al. Assessing the cardio-cerebrovascular safety of vildagliptin: meta-analysis of adjudicated events from a large Phase III type 2 diabetes population. Diabetes Obes Metab. 2010 ; 12: 485-494
62. White WB, Gorelick P, Fleck P, et al. Cardiovascular events in patients receiving alogliptin: findings from a pooled analysis of randomized clinical trials (abstract). Meeting of the 70th annual American Diabetes Association ; Orlando, FL ;. 391.
63. Scirica BM, Bhatt DL, Braunwald E, et al. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 ; 162: 818-825
64. White WB, Bakris GL, Bergenstal RM, et al. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J. 2011 ; 162: 620-626