Case-control study of oral glucose-lowering drugs in combination with long-acting insulin and the risks of incident myocardial infarction and incident stroke

Pharmacoepidemiology and Drug Safety

Volumn 25, Issue 2, 2016, Pages 151-160

  Floyd, James S ^a,b   Wiggins, Kerri L ^a   Christiansen, Mark ^a   Dublin, Sascha ^b,c   Longstreth, William T ^b   Smith, Nicholas L ^a,b,c,d   Mcknight, Barbara ^a,b   Heckbert, Susan R ^a,b,c   Weiss, Noel S ^b   Psaty, Bruce M ^a,b,c  

^a UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c GROUP HEALTH RESEARCH INSTITUTE   (United States)

^d DEPARTMENT OF VETERANS AFFAIRS   (United States)

Author keywords

Case control study; Insulin; Metformin; Myocardial infarction; Pharmacoepidemiology; Stroke; Sulfonylureas

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; GLUCOSE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN GLARGINE; ISOPHANE INSULIN; LONG ACTING INSULIN; METFORMIN; SHORT ACTING INSULIN; SULFONYLUREA; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; SULFONYLUREA DERIVATIVE;

ADULT; AGED; ARTICLE; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DRUG INTERACTION; FEMALE; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; POPULATION BASED CASE CONTROL STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK; CASE CONTROL STUDY; CHEMICALLY INDUCED; COMBINATION DRUG THERAPY; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; INCIDENCE; METABOLISM; MIDDLE AGED; MYOCARDIAL INFARCTION; ORAL DRUG ADMINISTRATION; RISK FACTOR; STROKE;

ADMINISTRATION, ORAL; ADULT; AGED; BLOOD GLUCOSE; CASE-CONTROL STUDIES; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INCIDENCE; INSULIN, LONG-ACTING; MALE; METFORMIN; MIDDLE AGED; MYOCARDIAL INFARCTION; RISK FACTORS; STROKE; SULFONYLUREA COMPOUNDS;

EID: 84955559002     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3914     Document Type: Article

References (52)

1. Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract 2014; 103(2): 137-149.
2. Sarwar N, Gao P, Seshasai SR, et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet 2010; 375(9733): 2215-2222.
3. Boussageon R, Supper I, Bejan-Angoulvant T, et al. Reappraisal of metformin efficacy in the treatment of type 2 diabetes: a meta-analysis of randomised controlled trials. PLoS Med 2012; 9(4) e1001204.
4. Monami M, Genovese S, Mannucci E. Cardiovascular safety of sulfonylureas: a meta-analysis of randomized clinical trials. Diabetes Obes Metab 2013; 15(10): 938-953.
5. Meinert CL, Knatterud GL, Prout TE, Klimt CR. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes 1970; 19(Suppl): 789-830.
6. Phung OJ, Schwartzman E, Allen RW, Engel SS, Rajpathak SN. Sulphonylureas and risk of cardiovascular disease: systematic review and meta-analysis. Diabetic Medicine 2013; 30(10): 1160-1171.
7. Abdelmoneim AS, Eurich DT, Light PE, et al. Cardiovascular safety of sulphonylureas: over 40years of continuous controversy without an answer. Diabetes Obes Metab 2015; 17(6): 523-532.
8. UK Prospective Diabetes Study (UKPDS) Group. 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(9131): 854-865.
9. Wallia A, Molitch ME. Insulin therapy for type 2 diabetes mellitus. JAMA 2014; 311(22): 2315-2325.
10. Centers for Disease Control. National Diabetes Statistics Report. 2014.
11. Hampp C, Borders-Hemphill V, Moeny DG, Wysowski DK. Use of antidiabetic drugs in the U.S., 2003-2012. Diabetes Care 2014; 37(5): 1367-1374.
12. Goudswaard AN, Furlong NJ, Rutten GE, Stolk RP, Valk GD. Insulin monotherapy versus combinations of insulin with oral hypoglycaemic agents in patients with type 2 diabetes mellitus. Cochrane Database Syst Rev 2004; 4 CD003418.
13. Hemmingsen B, Christensen LL, Wetterslev J, et al. Comparison of metformin and insulin versus insulin alone for type 2 diabetes: systematic review of randomised clinical trials with meta-analyses and trial sequential analyses. BMJ 2012; 344: e1771.
14. 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(6): 1364-1379.
15. Boger-Megiddo I, Heckbert SR, Weiss NS, et al. Myocardial infarction and stroke associated with diuretic based two drug antihypertensive regimens: population based case-control study. BMJ 2010; 340: c103.
16. Psaty BM, Heckbert SR, Atkins D, et al. The risk of myocardial infarction associated with the combined use of estrogens and progestins in postmenopausal women. Arch Intern Med 1994; 154(12): 1333-1339.
17. Psaty BM, Heckbert SR, Koepsell TD, et al. The risk of myocardial infarction associated with antihypertensive drug therapies. JAMA 1995; 274(8): 620-625.
18. Heckbert SR, Weiss NS, Koepsell TD, et al. Duration of estrogen replacement therapy in relation to the risk of incident myocardial infarction in postmenopausal women. Arch Intern Med 1997; 157(12): 1330-1336.
19. Klungel OH, Heckbert SR, Longstreth WT, Jr, et al. Antihypertensive drug therapies and the risk of ischemic stroke. Arch Intern Med 2001; 161(1): 37-43.
20. Miettinen O. Estimability and estimation in case-referent studies. Am J Epidemiol 1976; 103(2): 226-235.
21. Schafer JL. Analysis of Incomplete Multivariate Data. Chapman & Hall/CRC: Boca Raton, FL, 1997.
22. Kerr D, MacDonald IA, Heller SR, Tattersall RB. Beta-adrenoceptor blockade and hypoglycaemia. A randomised, double-blind, placebo controlled comparison of metoprolol CR, atenolol and propranolol LA in normal subjects. Br J Clin Pharmacol 1990; 29(6): 685-693.
23. Herings RM, de Boer A, Stricker BH, Leufkens HG, Porsius A. Hypoglycaemia associated with use of inhibitors of angiotensin converting enzyme. Lancet 1995; 345(8959): 1195-1198.
24. Lin DY, Psaty BM, Kronmal RA. Assessing the sensitivity of regression results to unmeasured confounders in observational studies. Biometrics 1998; 54(3): 948-963.
25. Roumie CL, Hung AM, Greevy RA, et al. Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: a cohort study. Ann Intern Med 2012; 157(9): 601-610.
26. 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). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998; 352(9131): 837-853.
27. Hong J, Zhang Y, Lai S, et al. Effects of metformin versus glipizide on cardiovascular outcomes in patients with type 2 diabetes and coronary artery disease. Diabetes Care 2013; 36(5): 1304-1311.
28. Mogensen UM, Andersson C, Fosbol EL, et al. Sulfonylurea in combination with insulin is associated with increased mortality compared with a combination of insulin and metformin in a retrospective Danish nationwide study. Diabetologia 2015; 58(1): 50-58.
29. Berkowitz SA, Krumme AA, Avorn J, et al. Initial choice of oral glucose-lowering medication for diabetes mellitus: a patient-centered comparative effectiveness study. JAMA Intern Med 2014; 174(12): 1955-1962.
30. Patorno E, Patrick AR, Garry EM, et al. Observational studies of the association between glucose-lowering medications and cardiovascular outcomes: addressing methodological limitations. Diabetologia 2014; 57(11): 2237-2250.
31. Flory JH, Hennessy S. Metformin use reduction in mild to moderate renal impairment: possible inappropriate curbing of use based on Food and Drug Administration contraindications. JAMA Intern Med 2015; 175(3): 458-459.
32. Nathan DM, Buse JB, Kahn SE, et al. Rationale and design of the glycemia reduction approaches in diabetes: a comparative effectiveness study (GRADE). Diabetes Care 2013; 36(8): 2254-2261.
33. Proks P, Reimann F, Green N, Gribble F, Ashcroft F. Sulfonylurea stimulation of insulin secretion. Diabetes 2002; 51(Suppl 3): S368-376.
34. Meier JJ, Gallwitz B, Schmidt WE, Mugge A, Nauck MA. Is impairment of ischaemic preconditioning by sulfonylurea drugs clinically important? Heart 2004; 90(1): 9-12.
35. Grover GJ, Sleph PG, Dzwonczyk S. Role of myocardial ATP-sensitive potassium channels in mediating preconditioning in the dog heart and their possible interaction with adenosine A1-receptors. Circulation 1992; 86(4): 1310-1316.
36. Toombs CF, Moore TL, Shebuski RJ. Limitation of infarct size in the rabbit by ischaemic preconditioning is reversible with glibenclamide. Cardiovasc Res 1993; 27(4): 617-622.
37. Mocanu MM, Maddock HL, Baxter GF, Lawrence CL, Standen NB, Yellon DM. Glimepiride, a novel sulfonylurea, does not abolish myocardial protection afforded by either ischemic preconditioning or diazoxide. Circulation 2001; 103(25): 3111-3116.
38. Desouza CV, Bolli GB, Fonseca V. Hypoglycemia, diabetes, and cardiovascular events. Diabetes Care 2010; 33(6): 1389-1394.
39. Wright RJ, Frier BM. Vascular disease and diabetes: is hypoglycaemia an aggravating factor? Diabetes Metab Res Rev 2008; 24(5): 353-363.
40. Desouza C, Salazar H, Cheong B, Murgo J, Fonseca V. Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care 2003; 26(5): 1485-1489.
41. Goto A, Arah OA, Goto M, Terauchi Y, Noda M. Severe hypoglycaemia and cardiovascular disease: systematic review and meta-analysis with bias analysis. BMJ 2013; 347: f4533.
42. Zoungas S, Patel A, Chalmers J, et al. Severe hypoglycemia and risks of vascular events and death. N Engl J Med 2010; 363(15): 1410-1418.
43. Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care 2005; 28(12): 2948-2961.
44. McAulay V, Deary IJ, Frier BM. Symptoms of hypoglycaemia in people with diabetes. Diabetic Medicine 2001; 18(9): 690-705.
45. Kooy A, de Jager J, Lehert P, et al. Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus. Arch Intern Med 2009; 169(6): 616-625.
46. Rena G, Pearson ER, Sakamoto K. Molecular mechanism of action of metformin: old or new insights? Diabetologia 2013; 56(9): 1898-1906.
47. Miller RA, Chu Q, Xie J, Foretz M, Viollet B, Birnbaum MJ. Biguanides suppress hepatic glucagon signalling by decreasing production of cyclic AMP. Nature 2013; 494(7436): 256-260.
48. Madiraju AK, Erion DM, Rahimi Y, et al. Metformin suppresses gluconeogenesis by inhibiting mitochondrial glycerophosphate dehydrogenase. Nature 2014; 510(7506): 542-546.
49. Calvert JW, Gundewar S, Jha S, et al. Acute metformin therapy confers cardioprotection against myocardial infarction via AMPK-eNOS-mediated signaling. Diabetes 2008; 57(3): 696-705.
50. Legtenberg RJ, Houston RJ, Oeseburg B, Smits P. Metformin improves cardiac functional recovery after ischemia in rats. Hormone and metabolic research=Hormon- und Stoffwechselforschung=Hormones et metabolisme 2002; 34(4): 182-185.
51. Kawabata H, Ishikawa K. Cardioprotection by metformin is abolished by a nitric oxide synthase inhibitor in ischemic rabbit hearts. Hypertens Res 2003; 26(1): 107-110.
52. Elmadhun NY, Sabe AA, Lassaletta AD, Chu LM, Sellke FW. Metformin mitigates apoptosis in ischemic myocardium. J Surg Res 2014; 192(1): 50-58.