Antidiabetic prescribing trends and predictors of thiazolidinedione discontinuation following the 2007 rosiglitazone safety alert

Diabetes Research and Clinical Practice

Volumn 93, Issue 1, 2011, Pages 49-55

  Hurren, Kathryn M ^a   Taylor, Thomas N ^a   Jaber, Linda A ^a  

^a WAYNE STATE UNIVERSITY   (United States)

Author keywords

Cardiovascular disease risk; Pioglitazone; Rosiglitazone; Safety; Thiazolidinedione

Indexed keywords

ANTIDIABETIC AGENT; EXENDIN 4; GLITAZONE DERIVATIVE; INSULIN; METFORMIN; PIOGLITAZONE; ROSIGLITAZONE; SITAGLIPTIN; SULFONYLUREA;

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; COMORBIDITY; CONTROLLED STUDY; DIABETES MELLITUS; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL SPECIALIST; PRESCRIPTION; SENSITIVITY ANALYSIS; SEX DIFFERENCE; TREND STUDY;

CARDIOVASCULAR DISEASES; COHORT STUDIES; DIABETES MELLITUS, TYPE 2; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; THIAZOLIDINEDIONES; UNITED STATES;

EID: 79960561033     PISSN: 01688227     EISSN: 18728227     Source Type: Journal    
DOI: 10.1016/j.diabres.2011.02.035     Document Type: Article

References (28)

1. Nissen S.E., 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.
2. Cobitz A., Zambanini A., Sowell M., Heise M., Louridas B., McMorn S., et al. A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14,237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone. Pharmacoepidemiol Drug Saf 2008, 17(8):769-781.
3. U.S. Food and Drug Administration. Information for healthcare professionals: rosiglitazone maleate (marketed as Avandia, Avandamet and Avandaryl). Available from: [accessed 22.12.09]. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143460.htm.
4. U.S. Food and Drug Administration. Summary minutes of the joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held on July 30, 2007. Available from: [accessed 22.12.09]. http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4308m1-final.pdf.
5. Dormandy J.A., Charbonnel B., Eckland D.J., Erdmann E., Massi-Benedetti M., Moules I.K., 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):1279-1289.
6. Mannucci E., Monami M., Lamanna C., Gensini G.F., Marchionni N. Pioglitazone and cardiovascular risk: a comprehensive meta-analysis of randomized clinical trials. Diabetes Obes Metab 2008, 10(12):1221-1238.
7. Lincoff A.M., Wolski K., Nicholls S.J., Nissen S.E. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. J Am Med Assoc 2007, 298(10):1180-1188.
8. Actos (pioglitazone) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2009.
9. Avandia (rosiglitazone) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2008.
10. Home P.D., Jones N.P., Pocock S.J., Beck-Nielsen H., Gomis R., Hanefeld M., 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(9681):2125-2135.
11. Nissen S.E., Wolski S. Rosiglitazone Revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med 2010, 170:1191-1201.
12. Graham D.J., Ouellet-Hellstrom R., MaCurdy T.E., Ali F., Sholley C., Worrall C., et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly medicare patients treated with rosiglitazone or pioglitazone. J Am Med Assoc 2010, 304(4):411-418.
13. Bilik D., McEwen L.N., Brown M.B., Selby J.V., Karter A.J., Marrero D.G., et al. Thiazolidinediones, cardiovascular disease and cardiovascular mortality: translating research into action for diabetes (TRIAD). Pharmacoepidemiol Drug Saf 2010, 19(7):715-721.
14. Loebstein R., Dushinat M., Vesterman-Landes J., Silverman B., Friedman N., Katzir I., et al. Database evaluation of the effects of long-term rosiglitazone treatment on cardiovascular outcomes in patients with type 2 diabetes. J Clin Pharmacol 2010, 10.1177/0091270010368281.
15. Brownstein J.S., Murphy S.N., Goldfine A.B., Grant R.W., Sordo M., Gainer V., et al. Rapid identification of myocardial infarction risk associated with diabetes medications using electronic medical records. Diabetes Care 2010, 33(3):526-531.
16. Wertz D.A., Chang C.L., Sarawate C.A., Willey V.J., Cziraky M.J., Bohn R.L. Risk of cardiovascular events and all-cause mortality in patients treated with thiazolidinediones in a managed-care population. Circ Cardiovasc Qual Outcomes 2010, 3(5):538-545.
17. Nathan D.M., Buse J.B., Davidson M.B., Ferrannini E., Holman R.R., Sherwin R., et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009, 32(1):193-203.
18. Woodcock J., Sharfstein J.M., Hamburg M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med 2010, 363:1489-1491.
19. Hosmer D.W., Lemeshow S. Applied logistic regression 2000, Wiley-Interscience, New York. 2nd ed.
20. Cohen A., Rabbani A., Shah N., Alexander G.C., Changes in glitazone use among office-based physicians in the U.S., 2003-2009 Diabetes Care 2010, 33(4):823-825.
21. Starner C.I., Schafer J.A., Heaton A.H., Gleason P.P. Rosiglitazone and pioglitazone utilization from January 2007 through May 2008 associated with five risk-warning events. J Manag Care Pharm 2008, 14(6):523-531.
22. Orrico K.B., Lin J.K., Wei A., Yue H. Clinical consequences of disseminating the rosiglitazone FDA safety warning. Am J Manag Care 2010, 16(5):111-116.
23. Shi L., Zhao Y., Szymanski K., Yau L., Fonseca V. Impact of thiazolidinedione safety warnings on medication use patterns and glycemic control among veterans with diabetes mellitus. J Diabetes Complications 2010, 10.1016/j.jdiacomp.2010.06.003.
24. Cohen RA, Stussman B. Health information technology use among men and women aged 18-64: early release of estimates from the National Health Interview Survey, January-June 2009. Available from: [accessed 06.07.10]. http://www.cdc.gov/nchs/data/hestat/healthinfo2009/healthinfo2009.htm.
25. Fox S, Jones S. The social life of health information. Available from: [accessed 06.07.10]. http://www.pewinternet.org/Reports/2009/8-The-Social-Life-of-Health-Information.aspx.
26. Shah N.D., Montori V.M., Krumholz H.M., Tu K., Alexander G.C., Jackevicius C.A. Responding to an FDA warning: geographic variation in the use of rosiglitazone. N Engl J Med 2010, 10.1056/nejmp1011042.
27. Rodbard H.W., Jellinger P.S., Davidson J.A., Einhorn D., Garber A.J., Grunberg G., et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract 2009, 15(6):540-559.
28. Birman-Deych E., Waterman A.D., Yan Y., Nilasena D.S., Radford M.J., Gage B.F. Accuracy of ICD-9-CM codes for identifying cardiovascular and stroke risk factors. Med Care 2005, 43(5):480-485.