Physicians’ Appraisal and Response to Early Evidence on Cardiovascular Risk Associated with Rosiglitazone: Knowledge Translation in Clinical Practice

Main Article Content

Garielle E. Brown
Adriane M. Lewin MSc
Michael A. De Souza BSc
Alun L Edwards MD
William A. Ghali MD MPH
Doreen M. Rabi MD MSc

Keywords

safety of rosiglitazone, hypoglycemic agent, treatment of type 2 diabetes mellitus,

Abstract

In 2007, a high-profile meta-analysis raised concerns about the safety of rosiglitazone, a thenpopular oral hypoglycemic agent. In this study, the authors describe how physicians accessed, evaluated, and applied this information clinically. Their findings showed that although a highly publicized meta-analysis raised concerns among physicians, meta-analyses can be challenging to interpret. Efforts are needed to improve the understanding of this methodology to aid physicians in translating results into practice.
Abstract 674 | PDF Downloads 310 HTML Downloads 462

References

1. Alexander GC, Sehgal NL, Moloney RM, et al. National trends in treatment of type 2 diabetes mellitus, 1994–2007. Arch Intern Med 2008;168(19):2088–94.

2. Moore DD. ‘No, really, how do they work?’ Genes Dev 2005;19(4):413–4.

3. Martens FM, Visseren FL, Lemay J, et al. Metabolic and additional vascular effects of thiazolidinediones. Drugs 2002;62(10):1463–80.

4. Sidhu JS, Cowan D, Kaski JC. The effects of rosiglitazone, a peroxisome proliferator-activated receptor-gamma agonist, on markers of endothelial cell activation, C-reactive protein, and fibrinogen levels in non-diabetic coronary artery disease patients. J Am Coll Cardiol 2003;42(10):1757–63.

5. Sidhu JS, Cowan D, Kaski JC. Effects of rosiglitazone on endothelial function in men with coronary artery disease without diabetes mellitus. Am J Cardiol 2004;94(2):151–6.

6. Schwartz AV, Sellmeyer DE, Vittinghoff E, et al. Thiazolidinedione use and bone loss in older diabetic adults. J Clin Endocrinol Metab 2006;91(9):3349–54.

7. Dormandy JA, Charbonnel B, Eckland DJ, 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(9493):1279–89.

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):2457–71.

9. Juurlink DN, Gomes T, Lipscombe LL, et al. Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: population based cohort study. BMJ 2009;339:b2942.

10. Lipscombe LL, Gomes T, Levesque LE, et al. Thiazolidinediones and cardiovascular outcomes in older patients with diabetes. JAMA 2007;298(22):2634–43.

11. Richter B, Bandeira-Echtler E, Bergerhoff K, et al. Rosiglitazone for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007;(3):CD006063.

12. Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA 2007;298(10):1189–95.

13. Starner CI, Schafer JA, Heaton AH, et al. Rosiglitazone and pioglitazone utilization from January 2007 through May 2008 associated with five riskwarning events. J Manag Care Pharm 2008;14(6):523–31.

14. 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 UK general practice research database. BMJ 2009;339:b4731.

15. European Medicines Agency. European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim. Anti-diabetes medication to be taken off the market. London, United Kingdom: The Agency; 2010; http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/09/WC5000 96996.pdf.

16. Woodcock J, Sharfstein JM, Hamburg M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med 2010;363(16):1489–91.

17. Sackett DL, Haynes RB, Guyatt GH, et al. Clinical Epidemiology: A Basic Science for Clinical Medicine, 2nd edition. Boston (MA): Little, Brown and Company; 1991.

18. De Vito C, Nobile CG, Furnari G, et al. Physicians’ knowledge, attitudes and professional use of RCTs and meta-analyses: a cross-sectional survey. Eur J Public Health 2009;19(3):297–302.

19. Berwick DM, Fineberg HV, Weinstein MC. When doctors meet numbers. Am J Med 1981;71(6):991–8.

20. Edwards P, Roberts I, Clarke M, et al. Methods to increase response rates to postal questionnaires. Cochrane Database Syst Rev 2007;(2):MR000008.

21. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ 2004;328(7454):1490.

22. Atkins D, Eccles M, Flottorp S, et al. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches. The GRADE Working Group. BMC Health Serv Res 2004;4(1):38.

23. Levitan D. Rosiglitazone: one year later. Thorofare (NJ): SLACK Inc., 2008; http://www.endocrinetoday.com/view.aspx?rid=29105.

24. Morrow RL, Carney G, Wright JM, et al. Impact of rosiglitazone meta-analysis on use of glucose-lowering medications. Open Med 2010;4(1):E50–9.

25. Shah BR, Juurlink DN, Austin PC, et al. New use of rosiglitazone decreased following publication of a meta-analysis suggesting harm. Diabet Med 2008;25(7):871–4.

26. Bilik D, McEwen LN, Brown MB, et al. Thiazolidinediones and fractures: evidence from translating research into action for diabetes. J Clin Endocrinol Metab 2010;95(10):4560–5.

27. 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(9593):1129–36.

Most read articles by the same author(s)