Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: A cohort study

Annals of Internal Medicine

Volumn 157, Issue 9, 2012, Pages 601-610

  Roumie, Christianne L ^a   Hung, Adriana M ^b   Greevy, Robert A ^c   Grijalva, Carlos G ^d   Liu, Xulei ^a   Murff, Harvey J ^b   Elasy, Tom A ^b   Griffin, Marie R ^e  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^c VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d VANDERBILT UNIVERSITY   (United States)

^e Vanderbilt Institute for Medicine and Public Health ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; CREATININE; GLIBENCLAMIDE; GLIPIZIDE; HEMOGLOBIN A1C; METFORMIN;

ACUTE HEART INFARCTION; ADULT; AGED; ALBUMINURIA; ARTICLE; BLOOD PRESSURE; BODY MASS; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CAUSE OF DEATH; CEREBROVASCULAR ACCIDENT; CHRONIC KIDNEY DISEASE; COMORBIDITY; CREATININE BLOOD LEVEL; DEMOGRAPHY; DRUG EFFECT; DRUG SAFETY; FEMALE; GLYCEMIC CONTROL; HEALTH CARE UTILIZATION; HOSPITALIZATION; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RETROSPECTIVE STUDY; TREATMENT OUTCOME;

EID: 84868652782     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-157-9-201211060-00003     Document Type: Article

References (51)

1. Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics-2012 update: a report from the American Heart Association. Circulation. 2012;125:188-97. [PMID: 22215894]
2. Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2012 update: a report from the American Heart Association. Circulation. 2012;125:e2-e220. [PMID: 22179539]
3. Centers for Disease Control and Prevention. National Diabetes Fact Sheet, 2011. 2011. Accessed at www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf on 27 March 2012.
4. Bolen S, Feldman L, Vassy J, Wilson L, Yeh HC, Marinopoulos S, et al. Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med. 2007;147:386-99. [PMID: 17638715]
5. Bennett WL, Maruthur NM, Singh S, Segal JB, Wilson LM, Chatterjee R, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011;154:602-13. [PMID: 21403054]
6. Lincoff AM, Wolski K, Nicholls SJ, Nissen SE. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA. 2007;298:1180-8. [PMID: 17848652]
7. 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. [PMID: 17517853]
8. Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med. 2010;170:1191-1201. [PMID: 20656674]
9. Arnold N, Hines D, Stroupe K. VIReC Technical Report 1: Comparison of VA Outpatient Prescriptions in the DSS Datasets and the PBM Database. Hines, IL: VA Information Resource Center; 2006. Accessed at www.virec.research.va.gov/Reports/TR/TR-DSS-PBM-OP-Rx-CY06-ER.pdf on 10 September 2012.
10. International Classification of Diseases, Ninth Revision, Clinical Modification. Hyattsville, MD: National Center for Health Statistics, Centers for Medicare & Medicaid Services; 1988.
11. Hynes DM, Koelling K, Stroupe K, Arnold N, Mallin K, Sohn MW, et al. Veterans' access to and use of Medicare and Veterans Affairs health care. Med Care. 2007;45:214-23. [PMID: 17304078]
12. Ray WA. Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol. 2003;158:915-20. [PMID: 14585769]
13. Choma NN, Griffin MR, Huang RL, Mitchel EF Jr, Kaltenbach LA, Gideon P, et al. An algorithm to identify incident myocardial infarction using Medicaid data. Pharmacoepidemiol Drug Saf. 2009;18:1064-71. [PMID: 19718697]
14. Rosamond WD, Chambless LE, Sorlie PD, Bell EM, Weitzman S, Smith JC, et al. Trends in the sensitivity, positive predictive value, false-positive rate, and comparability ratio of hospital discharge diagnosis codes for acute myocardial infarction in four US communities, 1987-2000. Am J Epidemiol. 2004;160:1137-46. [PMID: 15583364]
15. Petersen LA, Wright S, Normand SL, Daley J. Positive predictive value of the diagnosis of acute myocardial infarction in an administrative database. J Gen Intern Med. 1999;14:555-8. [PMID: 10491245]
16. Roumie CL, Mitchel E, Gideon PS, Varas-Lorenzo C, Castellsague J, Griffin MR. Validation of ICD-9 codes with a high positive predictive value for incident strokes resulting in hospitalization using Medicaid health data. Pharmacoepidemiol Drug Saf. 2008;17:20-6. [PMID: 17979142]
17. Arnold N, Sohn M, Maynard C, DM H. VIReC Technical Report 2: VA-NDI Mortality Data Merge Project. Hines, IL: VA Information Resource Center; 2006.
18. Yuan YC. Multiple Imputation for Missing Data: Concepts and New Development (Version 9.0). Rockville, MD: SAS Institute: 2011.
19. Lin D, Wei L. The robust inference for the Cox proportional hazards model. J Am Stat Assoc. 1989;84:1074-8.
20. Parsons L. Reducing bias in a propensity score matched-pair sample using greedy matching techniques [Abstract]. In: Proceedings of the Twenty-Sixth Annual SAS Users Group International Conference, Long Beach, California, 22-25 April 2001. Cary, NC: SAS Institute; 2001:214. Abstract 214-26.
21. D'Agostino R, Rubin D. Estimating and using propensity scores with partially missing data. J Am Stat Assoc. 2000;95:749-59.
22. Psaty BM, Koepsell TD, Lin D, Weiss NS, Siscovick DS, Rosendaal FR, et al. Assessment and control for confounding by indication in observational studies. J Am Geriatr Soc. 1999;47:749-54. [PMID: 10366179]
23. Schneeweiss S. Sensitivity analysis and external adjustment for unmeasured confounders in epidemiologic database studies of therapeutics. Pharmacoepidemiol Drug Saf. 2006;15:291-303. [PMID: 16447304]
24. Lin DY, Psaty BM, Kronmal RA. Assessing the sensitivity of regression results to unmeasured confounders in observational studies. Biometrics. 1998;54:948-63. [PMID: 9750244]
25. Schneeweiss S, Glynn RJ, Tsai EH, Avorn J, Solomon DH. Adjusting for unmeasured confounders in pharmacoepidemiologic claims data using external information: the example of COX2 inhibitors and myocardial infarction. Epidemiology. 2005;16:17-24. [PMID: 15613941]
26. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive bloodglucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352:854-65. [PMID: 9742977]
27. Selvin E, Bolen S, Yeh HC, Wiley C, Wilson LM, Marinopoulos SS, et al. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med. 2008;168:2070-80. [PMID: 18955635]
28. Goldner MG, Knatterud GL, Prout TE. Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. 3. Clinical implications of UGDP results. JAMA. 1971;218:1400-10. [PMID: 4941698]
29. Knatterud GL, Klimt CR, Jacobson ME, Goldner MG. The UGDP and insulin therapy: a reply [Letter]. Diabetes Care. 1979;2:247-8. [PMID: 520128]
30. Prout TE, Knatterud GL, Meinert CL, Klimt CR. The UGDP controversy. Clinical trials versus clinical impressions. Diabetes. 1972;21:1035-40. [PMID: 4561330]
31. Seltzer HS. A summary of criticisms of the findings and conclusions of the University Group Diabetes Program (UGDP). Diabetes. 1972;21:976-9. [PMID: 5055722]
32. Schor SS. Editorials: Statistical problems in clinical trials: the UGDP study revisited. Am J Med. 1973;55:727-32. [PMID: 4584989]
33. Bradley RF, Dolger H, Forsham PH, Seltzer H. "Settling the UGDP controversy"? JAMA. 1975;232:813-7. [PMID: 1091759]
34. 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. [PMID: 9742976]
35. Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, et al; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355:2427-43. [PMID: 17145742]
36. Roumie CL, Huizinga MM, Liu X, Greevy RA, Grijalva CG, Murff HJ, et al. The effect of incident antidiabetic regimens on lipid profiles in veterans with type 2 diabetes: a retrospective cohort. Pharmacoepidemiol Drug Saf. 2011;20:36-44. [PMID: 21182152]
37. Huizinga MM, Roumie CL, Greevy RA, Liu X, Murff HJ, Hung AM, et al. Glycemic and weight changes after persistent use of incident oral diabetes therapy: a Veterans Administration retrospective cohort study. Pharmacoepidemiol Drug Saf. 2010;19:1108-12. [PMID: 20878643]
38. 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;303:1410-8. [PMID: 20388897]
39. American Diabetes Association. Executive summary: standards of medical care in diabetes-2011. Diabetes Care. 2011;34 Suppl 1:S4-10. [PMID: 21193627]
40. American Diabetes Association. Standards of medical care in diabetes-2011. Diabetes Care. 2011;34 Suppl 1:S11-61. [PMID: 21193625]
41. Cryer DR, Nicholas SP, Henry DH, Mills DJ, Stadel BV. Comparative outcomes study of metformin intervention versus conventional approach the COSMIC Approach Study. Diabetes Care. 2005;28:539-43. [PMID: 15735184]
42. Alexander GC, Sehgal NL, Moloney RM, Stafford RS. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med. 2008;168:2088-94. [PMID: 18955637]
43. McAfee AT, Koro C, Landon J, Ziyadeh N, Walker AM. Coronary heart disease outcomes in patients receiving antidiabetic agents. Pharmacoepidemiol Drug Saf. 2007;16:711-25. [PMID: 17551989]
44. Tzoulaki I, Molokhia M, Curcin V, Little MP, Millett CJ, Ng A, et al. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database. BMJ. 2009;339:b4731. [PMID: 19959591]
45. Corrao G, Romio SA, Zambon A, Merlino L, Bosi E, Scavini M. Multiple outcomes associated with the use of metformin and sulphonylureas in type 2 diabetes: a population-based cohort study in Italy. Eur J Clin Pharmacol. 2011;67:289-99. [PMID: 21088829]
46. Kahler KH, Rajan M, Rhoads GG, Safford MM, Demissie K, Lu SE, et al. Impact of oral antihyperglycemic therapy on all-cause mortality among patients with diabetes in the Veterans Health Administration. Diabetes Care. 2007;30:1689-93. [PMID: 17440170]
47. Hung AM, Roumie CL, Greevy RA, Liu X, Grijalva CG, Murff HJ, et al. Comparative effectiveness of incident oral antidiabetic drugs on kidney function. Kidney Int. 2012;81:698-706. [PMID: 22258320]
48. Roumie CL, Liu X, Choma NN, Greevy RA, Hung AM, Grijalva CG, et al. Initiation of sulfonylureas versus metformin is associated with higher blood pressure at one year. Pharmacoepidemiol Drug Saf. 2012;21:515-23. [PMID: 22431419]
49. Pantalone KM, Kattan MW, Yu C, Wells BJ, Arrigain S, Jain A, et al. The risk of overall mortality in patients with type 2 diabetes receiving glipizide, glyburide, or glimepiride monotherapy: a retrospective analysis. Diabetes Care. 2010;33:1224-9. [PMID: 20215447]
50. Huizinga MM, Roumie CL, Elasy TA, Murff HJ, Greevy R, Liu X, et al. Changing incident diabetes regimens: a Veterans Administration cohort study from 2000 to 2005 [Letter]. Diabetes Care. 2007;30:e85. [PMID: 17855270]
51. Grymonpre R, Cheang M, Fraser M, Metge C, Sitar DS. Validity of a prescription claims database to estimate medication adherence in older persons. Med Care. 2006;44:471-7. [PMID: 16641666]