Dipeptidyl peptidase-4 inhibitor use in patients with type 2 diabetes and cardiovascular disease or risk factors

References

• Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States. 2014. Available from http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Last accessed 1 September 2015
   Google Scholar
• World Health Organization. Diabetes. Available from http://www.who.int/mediacentre/factsheets/fs312/en/index.html. Last accessed 1 September 2015
   Google Scholar
• International Diabetes Federation. IDF diabetes Atlas. Available from http://www.idf.org/sites/default/files/Atlas-poster-2014_EN.pdf. Last accessed 1 September 2015
   Google Scholar
• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, et al. Heart disease and stroke statistics–2013 update: a report from the American Heart Association. Circulation 2013;127:e6–e245
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2011
   Google Scholar
• Ferrannini E, DeFronzo RA. Impact of glucose-lowering drugs on cardiovascular disease in type 2 diabetes. Eur Heart J 2015;36:2288–96
   PubMed Web of Science ®Google Scholar
• Holman RR, Sourij H, Califf RM. Cardiovascular outcome trials of glucose-lowering drugs or strategies in type 2 diabetes. Lancet 2014;383:2008–17
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 2009;360:129–39
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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;359:1577–89
   PubMed Web of Science ®Google Scholar
• Hayward RA, Reaven PD, Wiitala WL, Bahn GD, Reda DJ, Ge L, et al. Follow-up of glycemic control and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2015;372:2197–206
   PubMed Web of Science ®Google Scholar
• Zoungas S, Patel A, Chalmers J, de Galan BE, Li Q, Billot L, et al. Severe hypoglycemia and risks of vascular events and death. N Engl J Med 2010;363:1410–18
   PubMed Web of Science ®Google Scholar
• ORIGIN Trial Investigators. Mellbin LG, Ryden L, Riddle MC, Probstfield J, Rosenstock J, et al. Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial. Eur Heart J 2013;34:3137–44
   PubMed Web of Science ®Google Scholar
• Hsu PF, Sung SH, Cheng HM, Yeh JS, Liu WL, Chan WL, et al. Association of clinical symptomatic hypoglycemia with cardiovascular events and total mortality in type 2 diabetes: a nationwide population-based study. Diabetes Care 2013;36:894–900
   PubMed Web of Science ®Google Scholar
• Stahn A, Pistrosch F, Ganz X, Teige M, Koehler C, Bornstein S, et al. Relationship between hypoglycemic episodes and ventricular arrhythmias in patients with type 2 diabetes and cardiovascular diseases: silent hypoglycemias and silent arrhythmias. Diabetes Care 2014;37:516–20
   PubMed Web of Science ®Google Scholar
• Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, et al. American Association of Clinical Endocrinologists’ comprehensive diabetes management algorithm 2013 consensus statement: executive summary. Endocr Pract 2013;19:1–48
   PubMed Web of Science ®Google Scholar
• ORIGIN Trial Investigators. Gerstein HC, Bosch J, Dagenais GR, Díaz R, Jung H, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012;367:319–28
   PubMed Web of Science ®Google Scholar
• Glucotrol® (glipizide tablets). Full Prescribing Information [package insert]. New York, NY: Pfizer, Inc; 2013
   Google Scholar
• Centers for Disease Control and Prevention (CDC). Vital signs: state-specific obesity prevalence among adults – United States, 2009. MMWR Morb Mortal Wkly Rep 2010;59:951–5
   PubMedGoogle Scholar
• Micronase® (glyburide tablets). Full Prescribing Information [package insert]. New York, NY: Pfizer, Inc; 2010
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. Drug safety communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines. Available from http://www.fda.gov/Drugs/DrugSafety/ucm376389.htm. Last accessed 20 August 2015
   Google Scholar
• Actos® (pioglitazone hydrochloride). Full Prescribing Information [package insert]. Deerfield, IL: Takeda Pharmaceuticals America, Inc; 2013
   Google Scholar
• Avandia® (rosiglitazone maleate). Full Prescribing Information [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2011
   Google Scholar
• Fievet C, Fruchart JC, Staels B. PPARalpha and PPARgamma dual agonists for the treatment of type 2 diabetes and the metabolic syndrome. Curr Opin Pharmacol 2006;6:606–14
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration Guidance for industry: diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Silver Spring, MD: Center for Drug Evaluation and Research. Available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf. Last accessed 1 September 2015
   Google Scholar
• Scheen AJ. A review of gliptins for 2014. Expert Opin Pharmacother 2015;16:43–62
   PubMed Web of Science ®Google Scholar
• Park H, Park C, Kim Y, Rascati KL. Efficacy and safety of dipeptidyl peptidase-4 inhibitors in type 2 diabetes: meta-analysis. Ann Pharmacother 2012;46:1453–69
   PubMed Web of Science ®Google Scholar
• Wu D, Li L, Liu C. Efficacy and safety of dipeptidyl peptidase-4 inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus: a meta-analysis. Diabetes Obes Metab 2014;16:30–7
   PubMed Web of Science ®Google Scholar
• Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, et al. American Association of Clinical Endocrinologists/American College of Endocrinology comprehensive diabetes management algorithm. Endocr Pract 2015;21:e1–e10
   PubMed Web of Science ®Google Scholar
• Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015;38:140–9
   PubMed Web of Science ®Google Scholar
• Scheen AJ. Cardiovascular effects of gliptins. Nat Rev Cardiol 2013;10:73–84
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Standards of medical care in diabetes-2015. Diabetes Care 2015;38:S1–S93
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Boehringer Ingelheim Pharmaceuticals. CARMELINA: Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in patients with type 2 diabetes mellitus at high vascular risk. US National Institutes of Health. ClinicalTrials.gov [online] Available from http://clinicaltrials.gov/ct2/show/NCT01897532?term=NCT01897532&rank=1. Last accessed 1 September 2015
   Google Scholar
• Marx N, Rosenstock J, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, et al. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA). Diab Vasc Dis Res 2015;12:164–74
   PubMed Web of Science ®Google Scholar
• Monami M, Ahren B, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and cardiovascular risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab 2013;15:112–20
   PubMed Web of Science ®Google Scholar
• Agarwal S, Parashar A, Menon V. Meta-analysis of the cardiovascular outcomes with dipeptidyl peptidase 4 inhibitors: validation of the current FDA mandate. Am J Cardiovasc Drugs 2014;14:191–207
   PubMed Web of Science ®Google Scholar
• Kannan S, Pantalone KM, Matsuda S, Wells BJ, Karafa M, Zimmerman RS. Risk of overall mortality and cardiovascular events in patients with type 2 diabetes on dual drug therapy including metformin: a large database study from the Cleveland Clinic. J Diabetes 2015. [Epub ahead of print]
   PubMedGoogle Scholar
• Yu OH, Yin H, Azoulay L. The combination of DPP-4 inhibitors versus sulfonylureas with metformin after failure of first-line treatment in the risk for major cardiovascular events and death. Can J Diabetes 2015. [Epub ahead of print]
   Google Scholar
• 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;51:1015–23
   PubMed Web of Science ®Google Scholar
• Monami M, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and heart failure: A meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis 2014;24:689–97
   PubMed Web of Science ®Google Scholar
• Clifton P. Do dipeptidyl peptidase IV (DPP-IV) inhibitors cause heart failure? Clin Ther 2014;36:2072–9
   PubMed Web of Science ®Google Scholar
• Fu AZ, Johnston S, Sheehan J, Ghannam A, Tsai K, Cappell K, et al. Risk of hospitalization for heart failure with dipeptidyl peptidase-4 inhibitors vs sulfonylureas and with saxagliptin vs sitagliptin in a US claims database. Diabetes 2015;64:LB42
   Google Scholar
• Giorda CB, Picariello R, Tartaglino B, Marafetti L, Di Noi F, Alessiato A, et al. Hospitalisation for heart failure and mortality associated with dipeptidyl peptidase 4 (DPP-4) inhibitor use in an unselected population of subjects with type 2 diabetes: a nested case-control study. BMJ Open 2015;5:e007959
   Google Scholar
• Seong JM, Choi NK, Shin JY, Chang Y, Kim YJ, Lee J, et al. Differential cardiovascular outcomes after dipeptidyl peptidase-4 inhibitor, sulfonylurea, and pioglitazone therapy, all in combination with metformin, for type 2 diabetes: a population-based cohort study. PLoS ONE 2015;10:e0124287
   PubMed Web of Science ®Google Scholar
• Morgan CL, Mukherjee J, Jenkins-Jones S, Holden SE, Currie CJ. 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;16:977–83
   PubMed Web of Science ®Google Scholar
• Mogensen UM, Andersson C, Fosbol EL, Schramm TK, 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;16:1001–8
   PubMed Web of Science ®Google Scholar
• 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. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• White WB, Pratley R, Fleck P, Munsaka M, Hisada M, Wilson C, Menon V. Cardiovascular safety of the dipetidyl peptidase-4 inhibitor alogliptin in type 2 diabetes mellitus. Diabetes Obes Metab 2013;15:668–73
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Marx N, Neubacher D, Seck T, Patel S, Woerle HJ, Johansen OE. Cardiovascular safety of linagliptin in type 2 diabetes: a comprehensive patient-level pooled analysis of prospectively adjudicated cardiovascular events. Cardiovasc Diabetol 2015;14:57
   PubMed Web of Science ®Google Scholar
• Iqbal N, Parker A, Frederich R, Donovan M, Hirshberg B. Assessment of the cardiovascular safety of saxagliptin in patients with type 2 diabetes mellitus: pooled analysis of 20 clinical trials. Cardiovasc Diabetol 2014;13:33
   PubMed Web of Science ®Google Scholar
• Engel SS, Golm GT, Shapiro D, Davies MJ, Kaufman KD, Goldstein BJ. Cardiovascular safety of sitagliptin in patients with type 2 diabetes mellitus: a pooled analysis. Cardiovasc Diabetol 2013;12:3
   PubMed Web of Science ®Google Scholar
• Wang KL, Liu CJ, Chao TF, Huang CM, Wu CH, Chen SJ, et al. Sitagliptin and the risk of hospitalization for heart failure: a population-based study. Int J Cardiol 2014;177:86–90
   PubMed Web of Science ®Google Scholar
• von Eynatten M, Gong Y, Emser A, Woerle HJ. Efficacy and safety of linagliptin in type 2 diabetes subjects at high risk for renal and cardiovascular disease: a pooled analysis of six phase III clinical trials. Cardiovasc Diabetol 2013;12:60
   PubMed Web of Science ®Google Scholar
• Cook W, Bryzinski B, Slater J, Frederich R, Allen E. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus and cardiovascular disease history or cardiovascular risk factors: Results of a pooled analysis of phase 3 clinical trials. Postgrad Med 2013;125:145–54
   PubMed Web of Science ®Google Scholar
• Cook C, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials Postgrad Med. 2014;126:19–32
   Google Scholar
• Weir DL, McAlister FA, Senthilselvan A, Minhas-Sandhu JK, Eurich DT. Sitagliptin use in patients with diabetes and heart failure: a population-based retrospective cohort study. JACC Heart Fail 2014;2:573–82
   PubMed Web of Science ®Google Scholar
• Chen DY, Wang SH, Mao CT, Tsai ML, Lin YS, Chou CC, et al. Sitagliptin and cardiovascular outcomes in diabetic patients with chronic kidney disease and acute myocardial infarction: a nationwide cohort study. Int J Cardiol 2015;181:200–6
   PubMed Web of Science ®Google Scholar
• Wang SH, Chen DY, Lin YS, Mao CT, Tsai ML, Hsieh MJ, et al. Cardiovascular outcomes of sitagliptin in type 2 diabetic patients with acute myocardial infarction, a population-based cohort study in Taiwan. PLoS ONE 2015;10:e0131122
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, et al. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J 2011;162:818–25
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Marx N, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, 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
   PubMed Web of Science ®Google Scholar
• Engel SS, Round E, Golm GT, Kaufman KD, Goldstein BJ. Safety and tolerability of sitagliptin in type 2 diabetes: pooled analysis of 25 clinical studies. Diabetes Ther 2013;4:119–45
   PubMed Web of Science ®Google Scholar