Cardiovascular risk of oral antidiabetic drugs: Current evidence and regulatory requirements for new drugs

Journal of Association of Physicians of India

Volumn 60, Issue 1, 2012, Pages 56-61

  Panicker, Gopi Krishna ^a   Karnad, Dilip R ^a,b   Salvi, Vaibhav ^a   Kothari, Snehal ^a  

^a IQVIA   (United States)

^b Seven Hills Hospital   (India)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; DRUG;

ARTICLE; CARDIOVASCULAR DISEASE; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL (TOPIC); DIABETIC ANGIOPATHY; DRUG APPROVAL; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; ORAL DRUG ADMINISTRATION; RISK FACTOR; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 2; DIABETIC ANGIOPATHIES; DRUG APPROVAL; HUMANS; HYPOGLYCEMIC AGENTS; PHARMACEUTICAL PREPARATIONS; RISK FACTORS; TREATMENT OUTCOME;

EID: 84855525536     PISSN: 00045772     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (68)

1. Gotto AM Jr. Cardiologist's role in improving glucose control and global cardiovascular risk in patients with type 2 diabetes mellitus. Am J Cardiol. 2007;99:3B-5B.
2. FDA Guidance for Industry. Diabetes Mellitus-Evaluation of Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf December 2008 (Accessed 15th July 2011).
3. Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and non-diabetic subjects and without prior myocardial infarction. N Engl J Med 1998;339:229-34.
4. Juutilainen A, Lehto S, Rönnemaa T, Pyörälä K, Laakso M. Type 2 diabetes as a "coronary heart disease equivalent": an 18-year prospective population-based study in Finnish subjects. Diabetes Care 2005;28:2901-7.
5. Goldberg RB. Cardiovascular disease in patients who have diabetes. Cardiol Clin 2003;21:399-413.
6. Grundy SM, Benjamin IJ, Burke GL, et al. Diabetes and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation 1999;100:1134-1146.
7. Selvin E, Marinopoulos S, Berkenblit G, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med 2004;141:421-31.
8. Gerstein HC, Pogue J, Mann JF, et al. The relationship between dysglycaemia and cardiovascular and renal risk in diabetic and non-diabetic participants in the HOPE study: a prospective epidemiological analysis. Diabetologia. 2005;48:1749-55.
9. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321:405-12.
10. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:837-853.
11. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854-865.
12. 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.
13. Peters AL, Davidson MB, Schriger DL, Hasselblad V: A clinical approach for the diagnosis of diabetes mellitus: an analysis using glycosylated hemoglobin levels. Meta-analysis Research Group on the Diagnosis of Diabetes Using Glycated Hemoglobin Levels. JAMA 1996;276:1246-1252.
14. Wieczorek A, Rys P, Skrzekowska-Baran I, Malecki M. The role of surrogate endpoints in the evaluation of efficacy and safety of therapeutic interventions in diabetes mellitus. Rev Diabet Stud 2008;5:128-135.
15. Stolar MW. Atherosclerosis in diabetes: the role of hyperinsulinemia. Metabolism 1988;37(2 Suppl 1):1-9.
16. Takahashi F, Hasebe N, Kawashima E, Takehara N, Aizawa Y, Akasaka K, et al. Hyperinsulinemia is an independent predictor for complex atherosclerotic lesion of thoracic aorta in non-diabetic patients. Atherosclerosis 2006;187:336-342.
17. Miranda VP, Rodrigues MJ, Gonçalves FR, Nunes JP. Effects of hypoglycemic agents on mortality and major cardiovascular outcomes in patients with type 2 diabetes mellitus: a narrative review. Rev Port Cardiol 2009;28:1099-119.
18. Deedwania PC, Fonseca VA. Diabetes, prediabetes, and cardiovascular risk: shifting the paradigm. Am J Med 2005;118:939-47.
19. Schwartz TB, Meinert CL. The UGDP controversy: thirty-four years of contentious ambiguity laid to rest. Perspect Biol Med 2004;47:564-74.
20. Chutkow WA, Simon MC, Le Beau MM, et al. Cloning, tissue expression, and chromosomal localisation of SUR2, the putative drug-binding subunit of cardiac, skeletal muscle, and vascular KATP channels. Diabetes 1996;45:1439-45.
21. Gribble FM, Tucker SJ, Seino S, et al. Tissue specificity of sulfonylureas: studies on cloned cardiac and beta-cell KATP channels. Diabetes 1998;47:1412-18.
22. Ashfield R, Gribble FM, Ashcroft SJH, et al. Identification of the high-affinity tolbutamide site on the SUR1 subunit of the KATP channel. Diabetes 1999;48:1-7.
23. Meier JJ, Gallwitz B, Schmidt WE, Mügge A, Nauck MA. Is impairment of ischaemic preconditioning by sulfonylurea drugs clinically important? Heart 2004;90:9-12.
24. Jørgensen CH, Gislason GH, Andersson C, et al. Effects of oral glucose-lowering drugs on long term outcomes in patients with diabetes mellitus following myocardial infarction not treated with emergent percutaneous coronary intervention--a retrospective nationwide cohort study. Cardiovasc Diabetol 2010;9:54.
25. Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-59.
26. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B. American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32:193-203.
27. Fisman EZ, Tenenbaum A. A cardiologic approach to non-insulin antidiabetic pharmacotherapy in patients with heart disease. Cardiovasc Diabetol 2009;8:38.
28. Zarich SW. Antidiabetic agents and cardiovascular risk in type 2 diabetes. Nat Rev Endocrinol 2009;5:500-506.
29. Endocrinologic and Metabolic Drugs Advisory Committee Meeting. FDA Web site. Available at: http://www.fda.gov/ohrms/dockets/ac/05/minutes/2005-4169M2.pdf. September 9, 2005. Accessibility verified July 15, 2011.
30. Nissen SE, Wolski K, Topol EJ. Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 2005;294:2581-2586.
31. Yun AJ, Lee PY, Doux JD. Paradoxical inflammation revisited: muraglitazar and cardiovascular risk. Med Hypotheses 2006;66:855.
32. Lockyer P, Schisler JC, Patterson C, Willis MS. Minireview: Won't get fooled again: the nonmetabolic roles of peroxisome proliferator-activated receptors (PPARs) in the heart. Mol Endocrinol 2010;24:1111-1119.
33. Rubenstrunk A, Hanf R, Hum DW, Fruchart JC, Staels B. Safety issues and prospects for future generations of PPAR modulators. Biochim Biophys Acta 2007;1771:1065-1081.
34. Blicklé JF. Meglitinide analogues: a review of clinical data focused on recent trials. Diabetes Metab 2006;32:113-120.
35. Repaglinide [package insert] Princeton, NJ: Novo Nordisk A/S; 2010.
36. Parker JC. Troglitazone: the discovery and development of a novel therapy for the treatment of Type 2 diabetes mellitus. Adv Drug Deliv Rev 2002;54:1173-1197.
37. European Medicines Agency. European public assessment report for Avandia. http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000268/WC500029109.pdf. (Accessed 15th July 2011).
38. Avandia [package insert] Philadelphia, PA: GSK; 2010.
39. United States Senate Committee on Finance page. Senate Finance Web site. http://finance.senate.gov/library/prints/download/?id=6ebe979f-6376-4d01-aa90-14483696fe54. (Accessed 15th July 2011).
40. 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.
41. FDA resources page. Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM226068.pdf. (Accessed 15th July 2011).
42. FDA resources page. Food and Drug Administration Web site. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218495.pdf. (Accessed 15th July 2011).
43. Mannucci E, Monami M, Di Bari M, et al. Cardiac safety profile of rosiglitazone. A comprehensive meta-analysis of randomized clinical trials. Int J Cardiol 2010;143:135-40.
44. Juurlink DN. Rosiglitazone and the case for safety over certainty. JAMA 2010;304:469-71.
45. Nissen SE, Wolski K. Rosiglitazone Revisited: An Updated Metaanalysis of Risk for Myocardial Infarction and Cardiovascular Mortality. Arch Intern Med 2010;170:1191-1201.
46. Cohen D. FDA puts rosiglitazone post-marketing trial on hold. BMJ 2010;341:c4017.
47. FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazonecontaining Medicines including Avandia, Avandamet, and Avandaryl. http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm. May 2011. (Accessed 15th July 2011).
48. Mannucci E, Monami M, Lamanna C, Gensini GF, Marchionni N. Pioglitazone and cardiovascular risk. A comprehensive meta-analysis of randomized clinical trials. Diabetes Obes Metab 2008;10:1221-38.
49. Lincoff AM, Wolski K, Nicholls SJ, Nissen SE. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA 2007;298:1180-8.
50. Juurlink DN, Gomes T, Lipscombe LL, Austin PC, Hux JE, Mamdani MM. Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: population based cohort study. BMJ 2009;339:b2942.
51. Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, Ali F, Sholley C, Worrall C, Kelman JA. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA 2010;304:411-418.
52. Home PD. Impact of the UKPDS-an overview. Diabet Med. 2008; 25(Suppl 2): 2-8.
53. Boyne MS, Saudek CD. Effect of insulin therapy on macrovascular risk factors in type 2 diabetes. Diabetes Care. 1999;22(Suppl 3):C45-53.
54. Gore MO, McGuire DK. The 10-year post-trial follow-up of the United Kingdom Prospective Diabetes Study (UKPDS): cardiovascular observations in context. Diab Vasc Dis Res 2009;6:53-55.
55. 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;359:1577-1589.
56. Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 2009;360:129-139.
57. Turnbull FM, Abraira C, Anderson RJ, Byington RP, Chalmers JP, Duckworth WC, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia 2009;52:2288-2298.
58. Masoudi FA, Inzucchi SE, Wang Y, Havranek EP, Foody JM, Krumholz HM. Thiazolidinediones, metformin, and outcomes in older patients with diabetes and heart failure: an observational study. Circulation 2005;111:583-590.
59. Eurich DT, Majumdar SR, McAlister FA, Tsuyuki RT, Johnson JA. Improved clinical outcomes associated with metformin in patients with diabetes and heart failure. Diabetes Care 2005;28:2345-2351.
60. Nichols GA, Koro CE, Gullion CM, Ephross SA, Brown JB. The incidence of congestive heart failure associated with antidiabetic therapies. Diabetes Metab Res Rev 2005;21:51-57.
61. Goldberg RB, Kendall DM, Deeg MA, et al; GLAI Study Investigators. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care 2005;28:1547-1554.
62. Mannucci E. Monami M. Lamanna C. Gori F. Marchionni N. Prevention of cardiovascular disease through glycemic control in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis 2009;19:604-612.
63. O'Keefe JH, Abuannadi M, Lavie CJ, Bell DS. Strategies for optimizing glycemic control and cardiovascular prognosis in patients with type 2 diabetes mellitus. Mayo Clin Proc 2011;86:128-38.
64. FDA Guidance for Industry. Diabetes Mellitus- Developing Drugs and Therapeutic Biologics for Treatment and Prevention. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071624.pdf. December 2008. (Accessed 15th July 2011).
65. EMA resources page. European Medicines Agency. Committee for Proprietary Medicinal Products (CPMP). Guideline on clinical investigation of medicinal products in the treatment of diabetes. CPMP/EWP/1080/00 Rev. 1. http://www.ema.europa.eu/docs/en_GB/documentlibrary/Scientific_guideline/2010/02/WC500073570.pdf.Jan 2010. (Accessed 15th July 2011).
66. Turner RJ, Caveney E. Regulatory landscapes for future antidiabetic drug development (Part II): EMA guidance on assessment of cardiovascular risk. J Clin Studies 2010:38-40.
67. Rosen CJ. The rosiglitazone story--lessons from an FDA Advisory Committee meeting. N Engl J Med. 2007;357:844-6.
68. Kolterman OG. Impact of Safety Issues on Early Stage Development: A Small Company Perspective. DIA Cardiovascular Safety in Drug Development: State-of-the-art Assessments. 2011.