A new "Comparative Effectiveness" assessment strategy using the THIN database: Comparison of the cardiac complications of pioglitazone and rosiglitazone

Pharmacoepidemiology and Drug Safety

Volumn 22, Issue 1, 2013, Pages 86-97

  Tannen, Richard ^a   Xie, Dawei ^a   Wang, Xingmei ^a   Yu, Menggang ^b   Weiner, Mark G ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

Comparative effectiveness research; Diabetes mellitus; EMR database; Myocardial infarction; Pharmacoepidemiology; Pioglitazone; Rosiglitazone

Indexed keywords

PIOGLITAZONE; ROSIGLITAZONE;

ACUTE HEART INFARCTION; ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; DATA BASE; DIABETES MELLITUS; FEASIBILITY STUDY; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RETROSPECTIVE STUDY; THE HEALTH IMPROVEMENT NETWORK DATABASE;

ADULT; AGED; COHORT STUDIES; COMPARATIVE EFFECTIVENESS RESEARCH; DATABASES, FACTUAL; DIABETES MELLITUS, TYPE 2; ELECTRONIC HEALTH RECORDS; FEASIBILITY STUDIES; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; THIAZOLIDINEDIONES;

EID: 84872127720     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3360     Document Type: Article

References (39)

1. Tannen RL, Weiner MG, Xie D. Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomized controlled trial findings. BMJ 2009; 338: b81. DOI:10.1136/bmj.b81
2. Tannen RL, Weiner MG, Marcus SM. Simulation of the Syst-Eur randomized control trial using a primary care electronic medical record was feasible. J Clin Epidemiol 2006; 59: 254-264.
3. Tannen RL, Weiner MG, Xie D, Barnhart K. A simulation using data from a primary care practice database closely replicated the women's health initiative trial. J Clin Epidemiol 2007; 60: 686-695.
4. Tannen RL, Weiner MG, Xie D, Barnhart K. Estrogen affects post-menopausal women differently than estrogen plus progestin therapy. Hum Reprod 2007; 22: 1769-1777.
5. Weiner MG, Xie D, Tannen RL. Replication of the Scandinavian Simvastatin Survival Study using a primary care medical record database prompted exploration of a new method to address unmeasured confounding. Pharmacoepidemiol Drug Saf 2008; 17: 661-670.
6. Tannen RL, Weiner MG, Xie D. Replicated studies of two randomized trials of angiotensin converting enzyme inhibitors: further empiric validation of the "prior event rate ratio" to adjust for unmeasured confounding by indication. Pharmacoepidemiol Drug Saf 2008; 17: 671-685.
7. Yu M, Xie D, Wang X, Weiner MG, Tannen RL. Prior event rate ratio (PERR) adjustment: Numerical studies of a statistical method to address unrecognized confounding in observational studies. Pharmacoepidemiol Drug Saf 2012; 21(S2): 60-68.
8. Nissen SE, Wolski K. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. N Engl J Med 2007; 356(24): 2457-2471.
9. Mulrow CD, Cornell JE, Localio AR. Rosiglitazone: A thunderstorm from scarce and fragile data. Ann Intern Med 2007; 147(8): 585-587.
10. Rosen JD. The Rosiglitazone Story - Lessons from an FDA advisoroy committee meeting. N Engl J Med 2007; 357(9): 844-846.
11. Diamond GA, Bax L, Kaul S. Uncertain effects of rosiglitazone on the risk of myocardial infarction and cardiovascular death. Ann Intern Med 2007; 147(8): 578-581.
12. Selvin E, Bolen S, Yeh HC, et al. Cardiovascular Outcomes in Trials of Oral Diabetes Medications. A Systematic Review. Arch Intern Med 2008; 168(19): 2070-2080.
13. Goldfine AB. Assessing the Cardiovascular Safety of Diabetes Therapies. N Engl J Med 2008; 359(11): 1092-1095.
14. Erdmann E, Charbonnel B, Robert Wilcox R. Thiazolidinediones and Cardiovascular Risk - A Question of Balance. Curr Cardiol Rev 2009; 5(3): 155-165.
15. Hennekens CH, DeMets D. The Need for Large-Scale Randomized Evidence Without Undue Emphasis on Small Trials, Meta-analyses, or Subgroup Analyses. JAMA 2009; 302(21): 2361-2362.
16. Juurlink DN. Rosiglitazone and the Case for Safety Over Certainty. Published Online: June 28, 2010. DOI:10.1001/JAMA.2010.954
17. Kaul S, Bolger AF, Herrington D, Giugliano RP, Eckel RP. Thiazolidinedione Drugs and Cardiovascular Risks: A Science Advisory from the American Heart Association and American College of Cardiology Foundation. Circulation 1-10. DOI:10.1161/CIR.0b013e3181d34114
18. Lipska KJ, Ross JS. Switching From Rosiglitazone. Thinking Outside the Class. JAMA 2011; 305(8): 820-821.
19. Bennett WL, Maruthur NM, Singh S, 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(9): 602-613.
20. Lago RM, Singh PP, Nesto RW. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials. Lancet 2007; 370: 1129-1136.
21. Singh L, Loke YK, Furberg FD. Thiazolidinediones and heart failure. A teleo-analysis. Diabetes Care 2007; 30(8): 2148-2153.
22. Lincoff AM, Wolski KM, 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(10): 1180-1188.
23. Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone. A meta-analysis. JAMA 2007; 298(10): 1189-1195.
24. Loke YK, Kwok CS, Singh S. Comparative cardiovascular effects of thiazolidinediones: systematic review and meta-analysis of observational studies. BMJ 2011; 342: d1309. DOI:10.1136/bmj.d1309
25. Lipscombe LL, Gomes T, Levesque LE, Jux JE, Juurlink DN, Alter DA. Thiazolidinediones and cardiovascular outcomes in older patients with Diabetes. JAMA 2007; 298(22): 2634-2643.
26. Diamond GA, Bax L, Kaul S. Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death. Ann Intern Med 2007; 147(8): 578-581.
27. Winkelmayer WC, Setoguchi S, Levin R, Solomon DH. Comparison of Cardiovascular Outcomes in Elderly Patients With Diabetes Who Initiated Rosiglitazone vs Pioglitazone Therapy. Arch Intern Med 2008; 168(21): 2368-2375.
28. Juurlink DN, Gomes T, Lipscombe LL, Austin PC, Hux JE, Mamdani MM. Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: population based cohort study. BMJ 2009; 339: b2942.
29. Margolis DJ, Hoffstad O, Strom BL. Association between serious ischemic cardiac outcomes and medications used to treat diabetes. Pharmacoepidemiol Drug Saf 2008; 17: 753-759.
30. Habib ZA, Tzogias L, Havstad SL, et al. Relationship between thiazolidinedione use and cardiovascular outcomes and all-cause mortality among patients with diabetes: A time-updated propensity analysis. Pharmacoepidemiol Drug Saf 2009; 18(6): 437-447.
31. Tzoulaki I, Molokhia M, Curcin V, et al. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using the UK general practice research database. BMJ 2009; 339: b4731.
32. Graham DJ, Ouellet-Hellstrom R, Thomas E, et al. Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone. JAMA 2010; 304(4): DOI:10.1001/jama.2010.920
33. Farkouh ME, Fuster V. Meta-analysis of small trials: proceed with caution. Nat Clini Pract Cardiovasc Med 2007; 4(3): 635.
34. Dormandy JA, Charbonnel B, Eckland DJA, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 2005; 366: 1279-1289.
35. Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes - an interim analysis. N Engl J Med 2007; 357(1): 28-38.
36. Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD):a multicentre, randomised, open-label trial. Lancet 2009; 373: 2125-2135.
37. Gelfand JM, Margolis DJ, Dattani H. The UK General Practice Research Database. In Pharmacoepidemiology (3rd edn), Strom BL (ed.). Wiley: Chichester, 2005; 337-346.
38. Jick H, Jick SS. Validation of information recorded on general practitioner based computerized data resource in the United Kingdom. BMJ 1991; 302: 766-768.
39. Lewis JD, Schinnar R, Bilker WB, Wang X, Strom BL. Validation studies of the health improvement network (THIN) database for pharmacoepidemiology. Pharmacoepidemiol Drug Saf 2007; 16: 393-340.