Cardiovascular safety of new drugs for diabetes: Getting the balance right?

Pharmaceutical Medicine

Volumn 28, Issue 3, 2014, Pages 109-117

  Krentz, Andrew J ^a   Hompesch, Marcus ^a  

^a Profil Institute for Clinical Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALOGLIPTIN; ANTIDIABETIC AGENT; CANAGLIFLOZIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLITAZONE DERIVATIVE; HEMOGLOBIN A1C; INSULIN; METFORMIN; NEW DRUG; ROSIGLITAZONE; SAXAGLIPTIN; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; SULFONYLUREA;

CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; COST EFFECTIVENESS ANALYSIS; DISEASE MARKER; DRUG EXPOSURE; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GLYCEMIC CONTROL; HEART FAILURE; HEART INFARCTION; HEART PROTECTION; HUMAN; INSULIN TREATMENT; LONG TERM EXPOSURE; NON INSULIN DEPENDENT DIABETES MELLITUS; NOTE; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REIMBURSEMENT;

EID: 84903736837     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.1007/s40290-014-0053-7     Document Type: Note

References (58)

1. Krentz AJ. Rosiglitazone: trials, tribulations and termination. Drugs 2011;71:123-30.
2. Bourg CA, Phillips BB. Rosiglitazone, myocardial ischemic risk, and recent regulatory actions. Ann Pharmacother. 2012;46:282-9.
3. 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. Silver Spring: FDA; 2008.
4. Adler AI. Drugs and diabetes: understanding the new breed of cardiovascular safety trials. Lancet Diabetes Endocrinol. 2013;1:175-7.
5. EMA guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus. Available from: http://www.ema.europa.eu/docs/ en-GB/document-library/Scientific-guideline/2010/02/WC500073570.pdf). Accessed 20 Dec 2013.
6. Ussher JR, Drucker DJ. Cardiovascular biology of the incretin system. Endocr Rev. 2012;33:187-215.
7. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317-26.
8. White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369:1327-35.
9. Lamanna C, Monami M, Marchionni N, Mannucci E. Effect of metformin on cardiovascular events and mortality: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2011;13:221-8.
10. 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. 2005;366:1279-89. (Pubitemid 41416583)
11. FDA drug safety communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR). Available from: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM385315.pdfre.). Accessed 25 Feb 2014.
12. Hiatt WR, Kaul S, Smith RJ. The cardiovascular safety of diabetes drugs: insights from the rosiglitazone experience. N Engl J Med 2013;369:1285-7.
13. Monami M, Dicembrini I, Martelli D, Mannucci E. Safety of dipeptidyl peptidase-4 inhibitors: a meta-analysis of randomized clinical trials. Curr Med Res Opin. 2011;27(Suppl 3):57-64.
14. 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.
15. Krentz AJ, Morrow L, Hompesch M. Developing new drugs for diabetes and cardiometabolic disorders: a changing paradigm. Drugs. 2012;72:1709-11.
16. Hirshberg B, Katz A. Cardiovascular outcome studies with novel antidiabetes agents: scientific and operational considerations. Diabetes Care. 2013;36(Suppl 2):S253-8.
17. Pelletier EM, Pawaskar M, Smith PJ, Best JH, Chapman RH. Economic outcomes of exenatide vs liraglutide in type 2 diabetes patients in the United States: results from a retrospective claims database analysis. J Med Econ. 2012;15:1039-50.
18. Novo Nordisk reported to police over disclosure delay on ruling. Available from: http://www.ft.com/intl/cms/s/0/6fc97422-6171-11e3-b7f1- 00144feabdc0.html?siteedition=uk#axzz30sKwfcop. Accessed 29 Dec 2013.
19. Gore MO, McGuire DK. Drugs for type 2 diabetes mellitus: the imperative for cardiovascular outcome assessment. Diab Vasc Dis Res 2012;9:85-8.
20. Kilo C, Miller JP, Williamson JR. The crux of the UGDP. Spurious results and biologically inappropriate data analysis. Diabetologia. 1980;18:179-85.
21. Wheeler S, Moore K, Forsberg CW, et al. Mortality among veterans with type 2 diabetes initiating metformin, sulfonylurea or rosiglitazone monotherapy. Diabetologia. Epub 25 Jun 2013.
22. Krentz AJ, Sinclair AJ. Do sulfonylureas still have a role in type 2 diabetes? Prescriber 2011;22:32-6.
23. Rosenstock J, Marx N, Kahn SE, et al. Cardiovascular outcome trials in type 2 diabetes and the sulphonylurea controversy: rationale for the active-comparator CAROLINA trial. Diab Vasc Dis Res. 2013;10:289-301.
24. ClinicalTrials.gov. CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients with Type 2 Diabetes. Available from: http://clinicaltrials.gov/show/NCT01243424. Accessed 22 Dec 2013.
25. Home P. Cardiovascular disease and oral agent glucose-lowering therapies in the management of type 2 diabetes. Diabetes Technol Ther. 2012;14(Suppl 1):S33-42.
26. 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;332:73-8.
27. Buse JB, Ginsberg HN, Bakris GL, et al. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Circulation. 2007;115:114-26. (Pubitemid 46058619)
28. Sattar N. Revisiting the links between glycaemia, diabetes and cardiovascular disease. Diabetologia. 2013;56:686-95.
29. Giraldez RR, Clare RM, Lopes RD, et al. Prevalence and clinical outcomes of undiagnosed diabetes mellitus and prediabetes among patients with high-risk non-ST-segment elevation acute coronary syndrome. Am Heart J. 2013;165(918-25):e2.
30. 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;35:1364-79.
31. 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;352:837-53.
32. Krentz AJ. Sulfonylureas in the prevention of vascular complications: from UKPDS to the ADVANCE study. In: Crepaldi GT, Avogaro A, editors. The metabolic syndrome: diabetes, obesity, hyperlipidemia and hypertension. Amsterdam: Excertpa Medical International Conference Series; 2002:261-77.
33. 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;352:854-65.
34. Lyons MR, Peterson LR, McGill JB, et al. Impact of sex on the heart's metabolic and functional responses to diabetic therapies. Am J Physiol Heart Circ Physiol. 2013;305:H1584-91.
35. Schramm TK, Gislason GH, Vaag A, 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;32:1900-8.
36. FDA Drug Safety Communication. FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines. 2013. Available from: http://www.fda.gov/drugs/drugsafety/ucm376389.htm.). Accessed 23 Dec 2013.
37. Nissen SE. Rosiglitazone: a case of regulatory hubris. BMJ. 2013;347:f7428.
38. 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;294:2581-6. (Pubitemid 41697247)
39. Lincoff AM, Tardif JC, Neal B, et al. Evaluation of the dual peroxisome proliferator-activated receptor alpha/gamma agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013;166:429-34.
40. 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. (Pubitemid 30609442)
41. Dluhy RG, McMahon GT. Intensive glycemic control in the ACCORD and ADVANCE trials. N Engl J Med. 2008;358: 2630-3. (Pubitemid 351831365)
42. Gerstein HC, Miller ME, Action to Control Cardiovascular Risk in Diabetes Study Group, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545-59. (Pubitemid 351831356)
43. Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009;360:129-39.
44. Patel A, MacMahon S, Advance Collaborative Group, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560-72. (Pubitemid 351831357)
45. US FDA. FDA news release. FDA approves Invokana to treat type 2 diabetes. Available from: http://www.fda.gov/newsevents/newsroom/pressannouncements/ ucm345848.htm. Accessed 3 Jan 2014.
46. ClinicalTrials.gov. CANVAS: CANagliflozin cardioVascular Assessment Study. Available from: http://clinicaltrials.gov/ct2/show/NCT01032629?term= CANVAS&rank=1. Accessed 3 Jan 2014.
47. Neal B, Perkovic V, de Zeeuw D, et al. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS): a randomized placebo-controlled trial. Am Heart J. 2013;166(217-23):e11.
48. Novo Nordisk. Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg®. Available from: http://www.novonordisk.com/ include/asp/exe-news-attachment.asp?sAttachmentGUID=83700060-0ce3-4577-a35a- f3e57801637d. Accessed 4 Jan 2014.
49. Insulin degludec and insulin degludec/insulin aspart treatment to improve glycemic control in patients with diabetes mellitus. NDAs 203314 and 203313. Briefing document. Available from: http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327017.pdf. Accessed 23 Dec 2013
50. US FDA. Degludec and degludec/aspart. Endocrinologic and Metabolic Drugs Advisory Committee Meeting, 8 Nov 2012. Available from: http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM330923.pdf. Accessed 4 Jan 2014.
51. Monnier L, Hanefeld M, Schnell O, Colette C, Owens D. Insulin and atherosclerosis: how are they related? Diabetes Metab. 2013;39:111-7.
52. Investigators OT, Gerstein HC, Bosch J, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012;367:319-28.
53. Rendell M. The path to approval of new drugs for diabetes. Expert Opin Drug Saf. 2013;12:195-207.
54. White WB, Kupfer S, Cushman WC, Bakris GL, Heller SK, Bergenstal RM, et al. Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes from the EXAMINE trial. Washington DC: American College of Cardiology 2014 Scientific Sessions; 2104.
55. Scheen AJ. Cardiovascular effects of gliptins. Nature Rev Cardiol. 2013;10:73-84.
56. Mullard A. Outcome results renew debate about diabetes drug development. Lancet Diabetes Endocrinol. 2013. doi:10.1016/S2213-8587(13)70118-9.
57. Ledford H. Diabetes drugs ride a bumpy road. Nature. 2013;504:198.
58. Serafino P. Sanofi pulls U.S. file for lixisenatide diabetes drug. Available from: http://www.bloomberg.com/news/2013-09-12/sanofi-pulls-u-s-file- for-lixisenatide-diabetes-drug.html. Accessed 6 Jan 2014.