Comparative cardiovascular risks of dipeptidyl peptidase 4 inhibitors with other second- and third-line antidiabetic drugs in patients with type 2 diabetes

British Journal of Clinical Pharmacology

Volumn 83, Issue 7, 2017, Pages 1556-1570

  Ou, Huang Tz ^a   Chang, Kai Cheng ^b   Li, Chung Yi ^a,c   Wu, Jin Shang ^a,d  

^a NATIONAL CHENG KUNG UNIVERSITY   (Taiwan)

^b CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^c CHINA MEDICAL UNIVERSITY   (Taiwan)

^d NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

Author keywords

cardiovascular diseases; dipeptidyl peptidase 4 inhibitors; hypoglycaemia; type 2 diabetes

Indexed keywords

ACARBOSE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLITAZONE DERIVATIVE; MEGLITINIDE; METFORMIN; SULFONYLUREA DERIVATIVE; ANTIDIABETIC AGENT;

ADULT; ARTICLE; BRAIN ISCHEMIA; CARDIOVASCULAR RISK; COMPARATIVE STUDY; FEMALE; HEART FAILURE; HEART INFARCTION; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MORTALITY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RISK ASSESSMENT; TREATMENT OUTCOME; AGED; CARDIOVASCULAR SYSTEM; CEREBROVASCULAR ACCIDENT; CHEMICALLY INDUCED; COHORT ANALYSIS; COMBINATION DRUG THERAPY; COMPLICATION; DRUG EFFECTS; HOSPITALIZATION; PROCEDURES; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODEL; RISK FACTOR; STATISTICS AND NUMERICAL DATA;

ADULT; AGED; CARDIOVASCULAR SYSTEM; COHORT STUDIES; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG THERAPY, COMBINATION; FEMALE; HEART FAILURE; HOSPITALIZATION; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; MYOCARDIAL INFARCTION; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODELS; RISK FACTORS; STROKE; SULFONYLUREA COMPOUNDS;

EID: 85013897266     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.13241     Document Type: Article

References (50)

1. Southan C, Sharman JL, Benson HE, Faccenda E, Pawson AJ, Alexander SP, et al. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. Nucl Acids Res 2016; 44 (Database Issue): D1054–D1068.
2. Alexander SPH, Fabbro D, Kelly E, Marrion N, Peters JA, Benson HE, et al. The Concise Guide to PHARMACOLOGY 2015/16: Enzymes. Br J Pharmacol 2015; 172: 6024–6109.
3. World Health Organization Diabetes Fact Sheet [online]. Available at http://www.who.int/mediacentre/factsheets/fs312/en/ (last accessed 23 March 2015).
4. Rydén L, Grant PJ, Anker SD, Berne C, Cosentino F, Danchin N, et al. ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J 2013; 34: 3035–3087.
5. Gu K, Cowie CC, Harris MI. Mortality in adults with and without diabetes in a national cohort of the US population, 1971–1993. Diabetes Care 1998; 21: 1138–1145.
6. Palmer SC, Mavridis D, Nicolucci A, Johnson DW, Tonelli M, Craig JC, et al. Comparison of clinical outcomes and adverse events associated with glucose-lowering drugs in patients with type 2 diabetes: a meta-analysis. JAMA 2016; 316: 313–324.
7. Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, et al. American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract 2013; 19: 327–336.
8. Khan FZ, Heck PM, Hoole SP, Dutka DP. DPP-4 inhibition by sitagliptin improves the myocardial response to dobutamine stress and mitigates stunning in a pilot study of patients with coronary artery disease. Circ Cardiovasc Imaging 2010; 3: 195–201.
9. Frederich R, Alexander JH, Fiedorek FT, Donovan M, Berglind N, Harris S, et al. A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for type 2 diabetes. Postgrad Med 2010; 122: 16–27.
10. 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.
11. 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: 1015–1023.
12. Mogensen U, Andersson C, Fosbøl E, Schramm T, Vaag A, Scheller NM, et al. Cardiovascular safety of combination therapies with incretin-based drugs and metformin compared with a combination of metformin and sulphonylurea in type 2 diabetes mellitus – a retrospective nationwide study. Diabetes Obes Metab 2014; 16: 1001–1008.
13. 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: 1317–1326.
14. Reaven PD, Moritz TE, Schwenke DC, Anderson RJ, Criqui M, Detrano R, et al. Intensive glucose-lowering therapy reduces cardiovascular disease events in veterans affairs diabetes trial participants with lower calcified coronary atherosclerosis. Diabetes 2009; 58: 2642–2648.
15. Morgan CL, Mukherjee J, Jenkins-Jones S, Holden S, Currie C. Combination therapy with metformin plus sulphonylureas versus metformin plus DPP-4 inhibitors: association with major adverse cardiovascular events and all-cause mortality. Diabetes Obes Metab 2014; 16: 977–983.
16. 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: 1317–1326.
17. Kannan S, Pantalone KM, Matsuda S, Wells BJ, Karafa M, Zimmerman RS. The risk of overall mortality and cardiovascular events in patients with type 2 diabetes on dual drug therapy including metformin: a large database study from Cleveland Clinic. J Diabetes 2015; 8: 279–285.
18. Ou S-M, Shih C-J, Chao P-W, Chu H, Kuo S-C, Lee Y-J, et al. Effects on clinical outcomes of adding dipeptidyl peptidase-4 inhibitors versus sulfonylureas to metformin therapy in patients with type 2 diabetes mellitus. Ann Intern Med 2015; 163: 663–672.
19. Fadini GP, Avogaro A, Degli Esposti L, Russo P, Saragoni S, Buda S, et al. Risk of hospitalization for heart failure in patients with type 2 diabetes newly treated with DPP-4 inhibitors or other oral glucose-lowering medications: a retrospective registry study on 127,555 patients from the Nationwide OsMed Health-DB Database. Eur Heart J 2015; 36: 2454–2462.
20. Chang YC, Chuang LM, Lin JW, Chen ST, Lai MS, Chang CH. Cardiovascular risks associated with second-line oral antidiabetic agents added to metformin in patients with Type 2 diabetes: a nationwide cohort study. Diabet Med 2015; 32: 1460–1469.
21. 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: 1327–1335.
22. United States Food and Drug Administration. FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin.
23. Cheng T-M. Taiwan's new national health insurance program: genesis and experience so far. Health Aff 2003; 22: 61–76.
24. American Diabetes Association 7. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52–S9.
25. Ou HT, Chang KC, Liu YM, Wu JS. Recent trends in the use of antidiabetic medications from 2008 to 2013: a nation-wide population-based study from Taiwan. J Diabetes 2017; 9: 256–266.
26. Ou H-T, Yang C-Y, Wang J-D, Hwang J-S, Wu J-S. Life expectancy and lifetime health care expenditures for type 1 diabetes: a nationwide longitudinal cohort of incident cases followed for 14 years. Value Health 2016; 19: 976–984.
27. Hou W-H, Chang K-C, Li C-Y, Ou H-T. Dipeptidyl peptidase-4 inhibitor use is not associated with elevated risk of severe joint pain in patients with type 2 diabetes: a population-based cohort study. Pain 2016; 157: 1954–1959.
28. Lin S-D, Tsai S-T, Tu S-T, Su C-C, Chen J-F, Lu C-H, et al. Glycosylated hemoglobin level and number of oral antidiabetic drugs predict whether or not glycemic target is achieved in insulin-requiring type 2 diabetes. Prim Care Diabetes 2015; 9: 135–141.
29. Heckman J, Ichimura H, Smith J, Todd P. Characterizing selection bias using experimental data: National Bureau of Economic Research 1998.
30. Dehejia RH, Wahba S. Propensity score-matching methods for nonexperimental causal studies. Rev Econ Stat 2002; 84: 151–161.
31. Li M. Using the propensity score method to estimate causal effects: a review and practical guide. Organ Res Methods 2013; 16: 188–226.
32. Austin PC, Grootendorst P, Normand SLT, Anderson GM. Conditioning on the propensity score can result in biased estimation of common measures of treatment effect: a Monte Carlo study. Stat Med 2007; 26: 754–768.
33. Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol 1994; 47: 1245–1251.
34. Chang H-Y, Weiner JP, Richards TM, Bleich SN, Segal JB. Validating the adapted Diabetes Complications Severity Index in claims data. Am J Manag Care 2012; 18: 721–726.
35. Cheng C-L, Chien H-C, Lee C-H, Lin S-J, Yang Y-HK. Validity of in-hospital mortality data among patients with acute myocardial infarction or stroke in National Health Insurance Research Database in Taiwan. Int J Cardiol 2015; 201: 96–101.
36. Hosmer DW, Lemeshow S, May S. Applied Survival Analysis: Regression Modeling of Time to Event Data (2nd edn). New Jersey: Wiley, 2008.
37. Kearney DJ, Crump C, Maynard C, Boyko EJ. A case–control study of endoscopy and mortality from adenocarcinoma of the esophagus or gastric cardia in persons with GERD. Gastrointest Endosc 2003; 57: 823–829.
38. Wiebe DJ. Firearms in US homes as a risk factor for unintentional gunshot fatality. Accid Anal Prev 2003; 35: 711–716.
39. Grimes DA, Schulz KF. Compared to what? Finding controls for case–control studies. Lancet 2005; 365: 1429–1433.
40. Satagopan J, Ben-Porat L, Berwick M, Robson M, Kutler D, Auerbach A. A note on competing risks in survival data analysis. Br J Cancer 2004; 91: 1229–1235.
41. Kohl M, Heinze G. PSHREG: A SAS macro for proportional and nonproportional substribution hazards regression with competing risk data. Vienna: Medical University of Vienna, 2013.
42. 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: 475–483.
43. White W, Pratley R, Fleck P, Munsaka M, Hisada M, Wilson C, et al. Cardiovascular safety of the dipetidyl peptidase-4 inhibitor alogliptin in type 2 diabetes mellitus. Diabetes Obes Metab 2013; 15: 668–673.
44. 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: 232–242.
45. Takasawa W, Ohnuma K, Hatano R, Endo Y, Dang NH, Morimoto C. Inhibition of dipeptidyl peptidase 4 regulates microvascular endothelial growth induced by inflammatory cytokines. Biochem Biophys Res Commun 2010; 401: 7–12.
46. Fadini GP, Avogaro A. Cardiovascular effects of DPP-4 inhibition: beyond GLP-1. Vascul Pharmacol 2011; 55: 10–16.
47. Wu JD, Xu XH, Zhu J, Ding B, Du TX, Gao G, et al. Effect of exenatide on inflammatory and oxidative stress markers in patients with type 2 diabetes mellitus. Diabetes Technol Ther 2011; 13: 143–148.
48. McMurray J. The Vildagliptin in Ventricular Dysfunction Diabetes trial (VIVIDD). European Society of Cardiology Heart Failure Association; 26 May 2013; Lisbon, Portugal; p. 99.
49. Cheng C-L, Lee C-H, Chen P-S, Li Y-H, Lin S-J, Yang Y-HK. Validation of acute myocardial infarction cases in the national health insurance research database in Taiwan. J Epidemiol 2014; 24: 500.
50. Hsieh C-Y, Chen C-H, Li C-Y, Lai M-L. Validating the diagnosis of acute ischemic stroke in a National Health Insurance claims database. J Formos Med Assoc 2015; 114: 254–259.