REVIEW OF THE QUALITY OF OBSERVATIONAL STUDIES OF THE ASSOCIATION BETWEEN ROSIGLITAZONE AND ACUTE MYOCARDIAL INFARCTION
Main Article Content
Keywords
Pharmacoepidemiology research, administrative data, confounding by indication, rosiglitazone, acute myocardial infarction
Abstract
Background
Following the publication of a meta-analysis reporting a risk of acute myocardial infarction (AMI) with rosiglitazone that led to severe restrictions being placed on its use, several observational studies of the association were reported. The lifting of restrictions in the United States in 2013 makes a review of these studies pertinent.
Objective
To evaluate the quality of population-based observational studies of the rosiglitazone - AMI association.
Methods
PubMed and Embase literature databases were searched for observational studies evaluating the association that were published between 2006 and 2010. Publications satisfying the inclusion criteria were reviewed using the Checklist for Retrospective Database Studies.
Results
Nineteen studies satisfied the inclusion criteria. Reasons for the research design and data source were absent or unclear in 18 (95%) and 16 (84%), respectively. Administrative data were used exclusively in 14 (74%). Baseline periods for prior diagnoses and medications varied widely. Reimbursement constraints on rosiglitazone use were reported in only seven studies (37%), although all were likely to have been impacted by them. What was being tested in half of the rosiglitazone treatment comparisons lacked specificity and clarity. All relied on risk ratios and, for 90% of the comparisons, the ratios were between 0.5 and two – a level at which residual confounding can lead to spurious significance.
Conclusion
Important deficiencies existed in the rosiglitazone studies suggesting that standards for methods and reporting of observational safety analyses need improvement. In particular, detailed clinical data should be included when the risk of confounding by indication is likely to be high.
References
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3. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovasc ular causes. N Engl J Med 2007;356: 2457 - 71.
4. Bracken MB. Rosiglitazone and cardiovascular risk [Lett] . N Engl J Med 2007; 357:937 - 8.
5. Mannucci E, Monami M, Marchionni N. Rosiglitazone and cardiovascular risk [Lett] . N Engl J Med 2007;357: 938.
6. Diamond GA, Kaul S. Rosiglitazone and cardiovascular risk [Lett] . N Engl J Med 2007;357: 938 - 9.
7. Diamond GA, Bax L, Kaul S. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med 2007;147: 578 - 81.
8. Shuster JJ, Jones L S, Salmon DA. Fixed v random effects in meta - analysis in rare event studies: the rosiglitazone link with myocardial infarction and cardiac death. Stat Med 2007;26: 4375 - 85.
9. Kaul S, Diamond GA. Rosiglitazone and cardiovascular risk. Curr Atheroscler Rep 2008 ;10: 398 - 404.
10. Friedrich JO, Beyene J, Adhikari NKJ. Rosiglitazone: can meta - analysis accurately estimate excess cardiovascular risk given the available data? Re - analysis of randomized trials using various methodologic approaches. BMC Res Notes 2009;2: 5.
11. Sui ssa S, Henry D, Caetano P, et al. CNODES: the Canadian Network for Observational Drug Effect Studies. Open Med 2012;6: e134.
12. FDA’s Sentinel Initiative. Silver Spring, MD: US Fo od and Drug Administration, 2014 . http://www.fda.gov/Safety/FDAsSentinelInitiati ve/default.htm (accessed: May 1, 2014 ).
13. European Network of Centres for Pharmacovigilance and Pharmacoepidemiology. London: Europ ean Me dicines Agency, 2014 . http://www.encepp.eu/ (accessed : May 1, 2014 ).
14. Schneeweiss S. Developments in post - marketing comparative effectiveness research. Clin Pharmacol Ther 2007;82: 143 - 56.
15. Schneeweiss S. Confounding. In: Hartzema AG, Tilson HH, Chan KA, eds. Pharmacoepidemiology and Therapeutic Risk Management. Cincin nati, OH: Harvey Whitney, 2008: 273 - 99.
16. Joffe MM. Confounding by indication: the case of calcium channel blockers. Pharmacoepidemiol Drug Saf 2000; 9 : 37 - 41.
17. Da le AC, Midthjell K, Nilsen TI, Wiseth R, Vatten LJ. Glycaemic control in newly diagnosed diabetes patients and mortality from ischaemic heart disease: 20 - year follow - up of the HUNT Study in Norway. Eur Heart J 2009;30: 1372 - 7.
18. FDA requires removal of certain restrictions on the diabetes drug Avandia. Silver Spring, MD: US Food and Drug Administration, 2013. http://www.fda.gov/NewsEvents/Newsroom/Pre ssAnnouncements/ucm3765 16.htm (accessed: May 1, 2014 ).
19. Strom BL. Methodologic challenges to studying patient safety and comparative effectiveness. Med Care 2007;45 (suppl 2): S13 - 5.
20. Pocock SJ, Collier TJ, Dandreo KJ, et al. Issues in the reporting of epidemiological studies: a surve y of recent practice. BMJ 2004;329: 883.
21. Von Elm E, Altman DG, Egger M, et al. The Strengthening The Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Epidemiology 2007;18: 800 - 4.
22. Vandenbroucke JP, von Elm E, Altman DG, et al. Strengthening The Reporting of Observational Studies in Epide miology (STROBE): explanation and elaboration. Epidemiology 2007;18: 805 - 35.
23. Motheral B, Brooks J, Clark MA, et al. A checklist for retrospective database studies – report of the ISPOR Task Force on Retrospective Databases. Value Health 2003;6: 90 - 7.
24. GRACE p rinciples: good research for comparative effectiveness. Cambridge, MA: GRACE Initiative, 2010. https://www.pharmacoepi.org/pub/1c29f69f - 2354 - d714 - 5100 - 1ef2b0e9abd9 (access ed : May 1, 2014 ).
25. Dreyer NA, Schneeweiss S, McNeil BJ, et al. GRACE principles: recognizing high - quality observational studies of comparative effectiveness. Am J Manag Care 2010;16: 467 - 71.
26. 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.
27. Gerrits CM, Bhattacharya M, Manthena S, Baran R, Perez A, Kupfer S. A comparison of pioglitazone and rosiglitazone for hospitalization f or acute myocardial infarction in type 2 diabetes. Pharmacoepidemiol Drug Saf 2007;16: 1065 - 71.
28. Lipscombe LL, Gomes T, Lévesque LE, Hux JE, Juurlink DN, Alter DA. Thiazolidinediones and cardiovascular outcomes in older patients with diabetes. JAMA 2007;298: 2634 - 43.
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 - 9.
30. Walker AM, Koro CE, Landon J. Coronary heart disease outcomes in patients re ceiving antidiabetic agents in the PharMetrics database 2000 - 2007. Pharmacoepidemiol Drug Saf 2008;17: 760 - 8.
31. Koro CE, Fu Q, Stender M. An assessment of the effect of thiazolidinedione exposure on the risk of myocardial infarction in type 2 diabetic patient s. Pharmacoepidemiol Drug Saf 2008;17: 989 - 96.
32. 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: 2368 - 75.
33. S tockl KM, Le L, Zhang S, Harada ASM. Risk of acute myocardial infarction in patients treated with thiazolidinediones or other antidiabetic medications. Pharmacoepidemiol Drug Saf 2009;18: 166 - 74.
34. Vanasse A, Carpentier AC, Courteau J, Asghari S. Stroke and c ardiovascular morbidity and mortality associated with rosiglitazone use in elderly diabetic patients. Diab Vasc Dis Res 200 9;6: 87 - 93.
35. Dormuth CR, Maclure M, Carney G, Schneeweiss S, Bassett K, Wright JM. Rosiglitazone and myocardial infarction in patients previously prescribed metformin. PLoS One 2009; 4: e6080.
36. 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: 437 - 47.
37. Dore DD, Trivedi AN, Mor V, Lapane KL. Association between extent of thiazolidinedione exposure and risk of acute myocardial infarction. Pharmacotherapy 2009;29: 775 - 83.
38. Hsiao FY, Huang WF, Wen YW, Chen PF, Kuo K N, Tsai YW. Thiazolidinediones and cardiovascular events in patients with type 2 diabetes mellitus: a retrospective cohort study of over 473,000 patients using a National Health Insurance database in Taiwan. Drug Saf 2009;32: 675 - 90.
39. Juurlink DN, Gomes T, L ipscombe LL, Austin PC, Hux JE, Mamdani MM. Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: population based cohort study. BMJ 2009;339: b2942.
40. Ziyadeh N, McAfee AT, Koro C, Landon J, Chan KA. The thiazolidinediones rosig litazone and pioglitazone and the risk of coronary heart disease: a retrospective cohort study using a US health insurance database. Clin Ther 2009;31: 2665 - 77.
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Nov 17, 2018
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Rawson, N. S. B. (2018). REVIEW OF THE QUALITY OF OBSERVATIONAL STUDIES OF THE ASSOCIATION BETWEEN ROSIGLITAZONE AND ACUTE MYOCARDIAL INFARCTION. Journal of Population Therapeutics and Clinical Pharmacology, 21(2). Retrieved from https://jptcp.com/index.php/jptcp/article/view/317
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