Linagliptin and cardiovascular outcomes in type 2 diabetes after acute coronary syndrome or acute ischemic stroke

Cardiovascular Diabetology

Volumn 17, Issue 1, 2018, Pages

  Li, Yan Rong ^a   Tsai, Sung Sheng ^a   Chen, Dong Yi ^a   Chen, Szu Tah ^a   Sun, Jui Hung ^a   Chang, Hung Yu ^a   Liou, Miaw Jene ^a   Chen, Tien Hsing ^a,b  

^a CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^b CHANG GUNG UNIVERSITY COLLEGE OF MEDICINE   (Taiwan)

Author keywords

Acute coronary syndrome; Acute ischemic stroke; Cardiovascular outcome; Dipeptidyl peptidase 4 (DPP 4) inhibitor; Linagliptin; Type 2 diabetes mellitus

Indexed keywords

INCRETIN; LINAGLIPTIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR;

ACUTE CORONARY SYNDROME; ADULT; AGED; ALL CAUSE MORTALITY; ARTICLE; BRAIN ISCHEMIA; CONTROLLED STUDY; CORONARY ARTERY BYPASS GRAFT; DISEASE ASSOCIATION; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HEART DEATH; HEART FAILURE; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; RETROSPECTIVE STUDY; CEREBROVASCULAR ACCIDENT; COMORBIDITY; FACTUAL DATABASE; MIDDLE AGED; MORTALITY; RISK FACTOR; TAIWAN; TIME FACTOR; TREATMENT OUTCOME; VERY ELDERLY;

ACUTE CORONARY SYNDROME; AGED; AGED, 80 AND OVER; BRAIN ISCHEMIA; COMORBIDITY; DATABASES, FACTUAL; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; FEMALE; HUMANS; LINAGLIPTIN; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; RISK FACTORS; STROKE; TAIWAN; TIME FACTORS; TREATMENT OUTCOME;

EID: 85042450975     PISSN: None     EISSN: 14752840     Source Type: Journal    
DOI: 10.1186/s12933-017-0655-y     Document Type: Article

References (54)

1. Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998;339:229-34
2. Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010;375:2215-22
3. Preis SR, Hwang SJ, Coady S, Pencina MJ, D'Agostino RB Sr, Savage PJ, et al. Trends in all-cause and cardiovascular disease mortality among women and men with and without diabetes mellitus in the Framingham Heart Study, 1950 to 2005. Circulation. 2009;119:1728-35
4. Morrish NJ, Wang SL, Stevens LK, Fuller JH, Keen H. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(Suppl 2):14-21
5. 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
6. Gerstein HC, Miller ME, Byington RP, GoffDC Jr, Bigger JT, Buse JB, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545-59
7. Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560-72
8. Gerstein HC, Miller ME, Genuth S, Ismail-Beigi F, Buse JB, GoffDC Jr, et al. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med. 2011;364:818-28
9. Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, et al. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013;369:145-54
10. Cavender MA, Steg PG, Smith SC, Eagle K, Ohman EM, Goto S, et al. Impact of diabetes mellitus on hospitalization for heart failure, cardiovascular events, and death: outcomes at 4 years from the reduction of atherothrombosis for continued health (REACH) registry. Circulation. 2015;132:923-31
11. Guidance for industry. diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Silver Spring: Food and Drug Administration; 2008
12. Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317-26
13. White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369:1327-35
14. Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;373:232-42
15. Zannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, et al. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015;385:2067-76
16. FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin. https://www.fda.gov/Drugs/DrugSafety/ucm486096.htm. Accessed 5 Apr 2016
17. Filion KB, Suissa S. DPP-4 inhibitors and heart failure: some reassurance, some uncertainty. Diabetes Care. 2016;39:735-7
18. Baetta R, Corsini A. Pharmacology of dipeptidyl peptidase-4 inhibitors: similarities and differences. Drugs. 2011;71:1441-67
19. Deacon CF, Holst JJ. Linagliptin, a xanthine-based dipeptidyl peptidase-4 inhibitor with an unusual profile for the treatment of type 2 diabetes. Expert Opin Investig Drugs. 2010;19:133-40
20. Graefe-Mody U, Friedrich C, Port A, Ring A, Retlich S, Heise T, et al. Effect of renal impairment on the pharmacokinetics of the dipeptidyl peptidase-4 inhibitor linagliptin. Diabetes Obes Metab. 2011;13:939-46
21. Boehringer Ingelheim. Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA). [ClinicalTrials.gov identifier: NCT01897532]. US National Institutes of Health, ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01897532 Accessed 2017 Oct 4
22. Boehringer ingelheim. CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes. [ClinicalTrials. gov identifier: NCT01243424]. US National Institutes of Health, ClinicalTrials. gov. https://clinicaltrials.gov/ct2/show/NCT01243424 Accessed 2017 Oct 4
23. McKeage K. Linagliptin: an update of its use in patients with type 2 diabetes mellitus. Drugs. 2014;74:1927-46
24. Barnett AH. Linagliptin for the treatment of type 2 diabetes mellitus: a drug safety evaluation. Expert Opin Drug Saf. 2015;14:149-59
25. Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012;380:475-83
26. Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. 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
27. Hsieh CY, Chen CH, Li CY, Lai ML. Validating the diagnosis of acute ischemic stroke in a National Health Insurance claims database. J Formos Med Assoc. 2015;114:254-9
28. Chang CH, Lee YC, Tsai CT, Chang SN, Chung YH, Lin MS, et al. Continuation of statin therapy and a decreased risk of atrial fibrillation/flutter in patients with and without chronic kidney disease. Atherosclerosis. 2014;232:224-30
29. Cheng CL, Lee CH, Chen PS, Li YH, Lin SJ, Yang YH. Validation of acute myocardial infarction cases in the national health insurance research database in taiwan. J Epidemiol. 2014;24:500-7
30. Cheng CL, Kao YH, Lin SJ, Lee CH, Lai ML. Validation of the National Health Insurance Research Database with ischemic stroke cases in Taiwan. Pharmacoepidemiol Drug Saf. 2011;20:236-42
31. Hsing AW, Ioannidis JP. Nationwide population science: lessons from the Taiwan National Health Insurance Research Database. JAMA Intern Med. 2015;175:1527-9
32. Wu CY, Chen YJ, Ho HJ, Hsu YC, Kuo KN, Wu MS, et al. Association between nucleoside analogues and risk of hepatitis B virus-related hepatocellular carcinoma recurrence following liver resection. JAMA. 2012;308:1906-14
33. Ou HT, Chang KC, Li CY, Wu JS. Risks of cardiovascular diseases associated with dipeptidyl peptidase-4 inhibitors and other antidiabetic drugs in patients with type 2 diabetes: a nation-wide longitudinal study. Cardiovasc Diabetol. 2016;15:41
34. Kim YG, Yoon D, Park S, Han SJ, Kim DJ, Lee KW, et al. Dipeptidyl peptidase-4 inhibitors and risk of heart failure in patients with Type 2 diabetes mellitus: a Population-Based Cohort Study. Circ Heart Fail. 2017;10(9):e003957
35. Lehrke M, Leiter LA, Hehnke U, Thiemann S, Bhandari A, Meinicke T, et al. Safety and efficacy of linagliptin in patients with type 2 diabetes mellitus and coronary artery disease: analysis of pooled events from 19 clinical trials. J Diabetes Complications. 2016;30:1378-84
36. Zinman B, Ahren B, Neubacher D, Patel S, Woerle HJ, Johansen OE. Efficacy and cardiovascular safety of linagliptin as an add-on to insulin in Type 2 diabetes: a Pooled Comprehensive Post Hoc Analysis. Can J Diabetes. 2016;40:50-7
37. Rosenstock J, Marx N, Neubacher D, Seck T, Patel S, Woerle HJ, et al. Cardiovascular safety of linagliptin in type 2 diabetes: a comprehensive patient-level pooled analysis of prospectively adjudicated cardiovascular events. Cardiovasc Diabetol. 2015;14:57
38. Lehrke M, Marx N, Patel S, Seck T, Crowe S, Cheng K, et al. Safety and tolerability of linagliptin in patients with Type 2 diabetes: a Comprehensive Pooled Analysis of 22 Placebo-controlled Studies. Clin Ther. 2014;36:1130-46
39. Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, et al. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014;130:1579-88
40. Manrique C, Habibi J, Aroor AR, Sowers JR, Jia G, Hayden MR, et al. Dipeptidyl peptidase-4 inhibition with linagliptin prevents western diet-induced vascular abnormalities in female mice. Cardiovasc Diabetol. 2016;15:94
41. Aroor AR, Habibi J, Kandikattu HK, Garro-Kacher M, Barron B, Chen D, et al. Dipeptidyl peptidase-4 (DPP-4) inhibition with linagliptin reduces western diet-induced myocardial TRAF3IP2 expression, inflammation and fibrosis in female mice. Cardiovasc Diabetol. 2017;16:61
42. Darsalia V, Ortsater H, Olverling A, Darlöf E, Wolbert P, Nyström T, et al. The DPP-4 inhibitor linagliptin counteracts stroke in the normal and diabetic mouse brain: a comparison with glimepiride. Diabetes. 2013;62:1289-96
43. Ma RC, Del Prato S, Gallwitz B, Shivane VK, Lewis-D'Agostino D, Bailes Z, et al. Oral glucose lowering with linagliptin and metformin compared with linagliptin alone as initial treatment in Asian patients with newly diagnosed type 2 diabetes and marked hyperglycemia: subgroup analysis of a randomized clinical trial. J Diabetes Investig. 2017. https://doi. org/10.1111/jdi.12746
44. Jax T, Stirban A, Terjung A, Esmaeili H, Berk A, Thiemann S, et al. A randomised, active-and placebo-controlled, three-period crossover trial to investigate short-term effects of the dipeptidyl peptidase-4 inhibitor linagliptin on macro-and microvascular endothelial function in type 2 diabetes. Cardiovasc Diabetol. 2017;16:13
45. Capes SE, Hunt D, Malmberg K, Pathak P, Gerstein HC. Stress hyperglycemia and prognosis of stroke in nondiabetic and diabetic patients: a systematic overview. Stroke. 2001;32:2426-32
46. Darsalia V, Nathanson D, Nystrom T, Klein T, Sjoholm A, Patrone C. GLP-1R activation for the treatment of stroke: updating and future perspectives. Rev Endocr Metab Disord. 2013;62:1289-96
47. Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013;12:1106-14
48. International DE, DECODA Study Group. Cardiovascular risk profile assessment in glucose-intolerant Asian individuals-an evaluation of the World Health Organization two-step strategy: the DECODA Study (Diabetes Epidemiology: Collaborative Analysis of Diagnostic Criteria in Asia). Diabet Med. 2002;19:549-57
49. DECODE Study Group, European Diabetes Epidemiology Study Group. Will new diagnostic criteria for diabetes mellitus change phenotype of patients with diabetes? Reanalysis of European epidemiological data. DECODE Study Group on behalf of the European Diabetes Epidemiology Study Group. BMJ. 1998;317:371-5
50. Ma RC. Acarbose: an alternative to metformin for first-line treatment in type 2 diabetes? Lancet Diabetes Endocrinol. 2014;2:6-7
51. Zhu Q, Tong Y, Wu T, Li J, Tong N. Comparison of the hypoglycemic effect of acarbose monotherapy in patients with type 2 diabetes mellitus consuming an Eastern or Western diet: a systematic meta-analysis. Clin Ther. 2013;35:880-99
52. Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002;359:2072-7
53. Weng J, Soegondo S, Schnell O, Sheu WH, Grzeszczak W, Watada H, et al. Efficacy of acarbose in different geographical regions of the world: analysis of a real-life database. Diabetes Metab Res Rev. 2015;31:155-67
54. Weng J, Ji L, Jia W, Lu J, Zhou Z, Zou D, et al. Standards of care for type 2 diabetes in China. Diabetes Metab Res Rev. 2016;32:442-58