The effect of sitagliptin on cardiovascular risk profile in Korean patients with type 2 diabetes mellitus: A retrospective cohort study

Therapeutics and Clinical Risk Management

Volumn 12, Issue , 2016, Pages 435-444

  Shin, Sooyoung ^a   Kim, Hyunah ^b  

^a Ajou University   (South Korea)

^b Sookmyung Women's University   (South Korea)

Author keywords

Cardiovascular outcomes; Dipeptidyl peptidase 4 inhibitors; Sitagliptin; Type 2 diabetes

Indexed keywords

DIPEPTIDYL PEPTIDASE IV INHIBITOR; MEGLITINIDE; METFORMIN; SITAGLIPTIN; SULFONYLUREA;

ADULT; ARTICLE; BRAIN ISCHEMIA; CARDIOVASCULAR RISK; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; COMORBIDITY; CONTROLLED STUDY; DISEASE ASSOCIATION; DISEASE DURATION; DRUG SAFETY; FEMALE; HEART DEATH; HEART FAILURE; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; HYPOGLYCEMIA; KOREAN (PEOPLE); MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PANCREAS DISEASE; PROPORTIONAL HAZARDS MODEL; RETROSPECTIVE STUDY; TERTIARY CARE CENTER; TREATMENT DURATION; UNSTABLE ANGINA PECTORIS;

EID: 84961238802     PISSN: 11766336     EISSN: 1178203X     Source Type: Journal    
DOI: 10.2147/TCRM.S105285     Document Type: Article

References (45)

1. Gerstein HC, Pogue J, Mann JFE, 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(9):1749-1755
2. Selvin E, Marinopoulos S, Berkenblit G, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med. 2004;141(6):421-431
3. Laakso M. Diabetes as a ‘cardiovascular disease equivalent’: implications for treatment. Nat Clin Pract Cardiovasc Med. 2008;5(11): 682-683
4. Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358(24):2545-2559
5. 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
6. Simpson SH, Majumdar SR, Tsuyuki RT, Eurich DT, Johnson JA. Dose- response relation between sulfonylurea drugs and mortality in type 2 diabetes mellitus: a population-based cohort study. CMAJ. 2006;174(2): 169-174
7. Delea TE, Edelsberg JS, Hagiwara M, Oster G, Phillips LS. Use of thiazolidinediones and risk of heart failure in people with type 2 diabetes: a retrospective cohort study. Diabetes Care. 2003;26(11):2983-2989
8. 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(5):583-590
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(24):2457-2471
10. 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(15):1577-1589
11. American Diabetes Association. Standards of medical care in diabetes - 2015. Diabetes Care. 2015;38 Suppl:S1-S93
12. Guidance for industry: diabetes mellitus - evaluation cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. US Food and Drug Administration; 2008. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid-ances/ucm071627.pdf. Accessed January 15, 2016
13. 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(14): 1327-1335
14. 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(14):1317-1326
15. Green JB, Bethel MA, Armstrong PW, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;373(3): 232-242
16. Udell JA, Cavender MA, Bhatt DL, Chatterjee S, Farkouh ME, Scirica BM. Glucose-lowering drugs or strategies and cardiovascular outcomes in patients with or at risk for type 2 diabetes: a metaanalysis of randomised controlled trials. Lancet Diabetes Endocrinol. 2015;3(5):356-366
17. 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(3):16-27
18. Monami M, Ahrén B, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and cardiovascular risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2013;15(2):112-120
19. Scheen AJ. Cardiovascular effects of gliptins. Nat Rev Cardiol. 2013;10(2):73-84
20. Kim SC, Glynn RJ, Liu J, Everett BM, Goldfine AB. Dipeptidyl peptidase-4 inhibitors do not increase the risk of cardiovascular events in type 2 diabetes: a cohort study. Acta Diabetol. 2014;51(6):1015-1023
21. Hampp C, Borders-Hemphill V, Moeny DG, Wysowski DK. Use of antidiabetic drugs in the US, 2003-2012. Diabetes Care. 2014;37(5): 1367-1374
22. Kim YG, Hahn S, Oh TJ, Kwak SH, Park KS, Cho YM. Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis. Diabetologia. 2013;56(4):696-708
23. Herman WH, Edelstein SL, Ratner RE, et al. Effectiveness and cost- effectiveness of diabetes prevention among adherent participants. Am J Manag Care. 2013;19(3):194-202
24. Diabetes Prevention Program Research Group. Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study. Diabetes Care. 2012;35(4):731-737
25. Johnson JA, Simpson SH, Toth EL, Majumdar SR. Reduced cardiovascular morbidity and mortality associated with metformin use in subjects with Type 2 diabetes. Diabet Med. 2005;22(4):497-502
26. Fontbonne A, Charles MA, Juhan-Vague I, et al. The effect of metformin on the metabolic abnormalities associated with upper-body fat distribution. BIGPRO Study Group. Diabetes Care. 1996;19(9):920-926
27. Kitabchi AE, Temprosa M, Knowler WC, et al. Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the diabetes prevention program: effects of lifestyle intervention and metformin. Diabetes. 2005;54(8):2404-2414
28. Hiatt WR, Kaul S, Smith RJ. The cardiovascular safety of diabetes drugs - insights from the rosiglitazone experience. N Engl J Med. 2013; 369(14):1285-1287
29. Rawson NS. Review of the quality of observational studies of the association between rosiglitazone and acute myocardial infarction. J Popul Ther Clin Pharmacol. 2014;21(2):e214-e232
30. FDA Drug Safety Communication: updated risk evaluation and mitigation strategy (REMS) to restrict access to rosiglitazone-containing medicines including Avandia, Avandamet, and Avandaryl. US Food and Drug Administration; 2011. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm. Accessed January 15, 2016
31. Friedrich JO, Beyene J, Adhikari NK. Rosiglitazone: can meta-analysis accurately estimate excess cardiovascular risk given the available data? Re-analysis of randomized trials using various methodologic approaches. BMC Res Notes. 2009;2:5
32. Diamond GA, Bax L, Kaul S. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med. 2007;147(8):578-581
33. FDA requires removal of certain restrictions on the diabetes drug Avandia. US Food and Drug Administration; 2013. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376516.htm. Accessed January 15, 2016
34. 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(9681):2125-2135
35. Kung J, Henry RR. Thiazolidinedione safety. Expert Opin Drug Saf. 2012;11(4):565-579
36. Thornberry NA, Gallwitz B. Mechanism of action of inhibitors of dipeptidyl-peptidase-4 (DPP-4). Best Pract Res Clin Endocrinol Metab. 2009;23(4):479-486
37. Ma RC, Chan JC. Type 2 diabetes in East Asians: similarities and dif- ferences with populations in Europe and the United States. Ann N Y Acad Sci. 2013;1281:64-91
38. Aso Y, Ozeki N, Terasawa T, et al. Serum level of soluble CD26/ dipeptidyl peptidase-4 (DPP-4) predicts the response to sitagliptin, a DPP-4 inhibitor, in patients with type 2 diabetes controlled inadequately by metformin and/or sulfonylurea. Transl Res. 2012;159(1):25-31
39. Nakagami T; DECODA Study Group. Hyperglycaemia and mortality from all causes and from cardiovascular disease in five populations of Asian origin. Diabetologia. 2004;47(3):385-394
40. Deacon CF. Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diabetes Obes Metab. 2011; 13(1):7-18
41. Ahrén B. Emerging dipeptidyl peptidase-4 inhibitors for the treatment of diabetes. Expert Opin Emerg Drugs. 2008;13(4):593-607
42. Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010;303(14): 1410-1418
43. Pratley RE, Salsali A. Inhibition of DPP-4: a new therapeutic approach for the treatment of type 2 diabetes. Curr Med Res Opin. 2007;23(4): 919-931
44. Williams-Herman D, Round E, Swern AS, et al. Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis. BMC Endocr Disord. 2008;8:14
45. Gallwitz B. Sitagliptin: profile of a novel DPP-4 inhibitor for the treatment of type 2 diabetes. Drugs Today (Barc). 2007;43(1):13-25.