Rosiglitazone and pioglitazone utilization from January 2007 through May 2008 associated with five risk-warning events

Journal of Managed Care Pharmacy

Volumn 14, Issue 6, 2008, Pages 523-531

  Starner, Catherine I ^a,b   Schafer, Jeremy A ^a   Heaton, Alan H ^c,d   Gleason, Patrick P ^a,b  

^a Prime Therapeutics LLC   (United States)

^b UNIVERSITY OF MINNESOTA   (United States)

^c Blue Cross Blue Shield of Minnesota   (United States)

^d UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; GLIMEPIRIDE PLUS PIOGLITAZONE; GLIMEPIRIDE PLUS ROSIGLITAZONE; INSULIN; METFORMIN PLUS PIOGLITAZONE; METFORMIN PLUS ROSIGLITAZONE; NITRATE; PIOGLITAZONE; ROSIGLITAZONE; SITAGLIPTIN;

ADD ON THERAPY; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CARDIOVASCULAR SURGERY; CLINICAL TRIAL; COHORT ANALYSIS; CONGESTIVE HEART FAILURE; CORONARY ARTERY BYPASS GRAFT; CORONARY STENT; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG FORMULARY; DRUG LABELING; DRUG SAFETY; DRUG UTILIZATION; EDEMA; FLUID RETENTION; FOOD AND DRUG ADMINISTRATION; HEART FAILURE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HEART MUSCLE REVASCULARIZATION; HUMAN; HYPOGLYCEMIA; INTERNATIONAL CLASSIFICATION OF DISEASES; MEDICAL DECISION MAKING; NON INSULIN DEPENDENT DIABETES MELLITUS; ONLINE SYSTEM; PHARMACEUTICAL CARE; RISK ASSESSMENT; SIDE EFFECT; UNITED STATES; WEIGHT GAIN;

EID: 51349164431     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2008.14.6.523     Document Type: Article

References (28)

1. Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycemia in type 2 diabetes a consensus algorithm for the initiation and adjustment of therapy. Diabetes Care. 2008;31:173-75.
2. Drug Topics. Available at: www.drugtopics.com/Top+200+Drugs. Accessed December 31, 2007.
3. Irons BK, Green RS, Mazzolini TA, Edwards KL, Sleeper RB. Implications of rosiglitazone and pioglitazone on cardiovascular risk in patients with type 2 diabetes mellitus. Pharmacotherapy. 2006;26:168-81.
4. Choi D, Jang Y, Kim SK, et al. Preventative effects of rosiglitazone on restenosis after coronary stent implantation in patients with type 2 diabetes. Diabetes Care. 2004;27:2654-60.
5. Marx N, Wohrle J, Nusser T, et al. Pioglitazone reduces neointima volume after coronary stent implantation. A randomized, placebo-controlled, double-blind trial in nondiabetic patients. Circulation, 2005;112:2792-98.
6. Dormandy JA, Charbannel B, Eckland DA, et al. Secondary prevention of macrovascular events in patiems with type 2 diabetes in the PROactive study (prospective pioglitazone clinical trial in macrovascular events): a randomized controlled trial. Lancet. 2005;366:1279-89.
7. U.S. Food and Drug Administration. Label and approval history for Avandia. Available at: www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm?fuseaction=Search.Label_ApprovalHistory. Accessed June 13, 2008.
8. Avandia (rosiglitazone) [package insert]. Philadelphia, PA: SmithKline Beecham Pharmaceuticals; 1999. Available at: www.fda.gov/cder/foi/label/ 1999/21071lbl.pdf. Accessed June 20, 2008.
9. U.S. Food and Drug Administration. Label and Approval History for Actos. Available at: www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist. Accessed June 13, 2008.
10. Actos (pioglitazone) [package insert]. Lincolnshire, IL: Takeda Pharmaceuticals America, Inc.; 1999. Available at: www.fda.gov/cder/foi/ label/1999/21073lbl.pdf. Accessed June 20, 2008.
11. Nesto RW, Bell D, Bonow RO, et al. Thiazolidinedione use, fluid retention, and congestive heart failure. A consensus statement from the American Heart Association and American Diabetes Association. Diabetes Care. 2004;27:256-63.
12. 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. Available at: http://content.nejm.org/cgi/content/ abstract/356/24/2457. Accessed June 20, 2008.
13. Glaxo Smith Kline. Study No.: ZM2005/0018/01: Avandia Cardiovascular Event Modeling Project Study No.: HM2006/00497/00/WEUSRTP866: Coronary Heart Disease Outcomes in Patients Receiving Antidiabetic Agents. Available at: http://ctr.gsk.co.uk/Summary/Rosiglitazone/ III_CVmodeling.pdf. Accessed July 7, 2008.
14. Division of Metabolism and Endocrine Products and Office of Surveillance and Epidemiology, U.S. Food and Drug Administration. FDA Briefing Document: joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee held on July 30, 2007. Available at: www.fda.gov/ ohrms/dockets/ac/07/briefing/2007-4308b1-02-fda-backgrounder.pdf. Accessed October 12, 2007.
15. Rosen CJ. The rosightazone story - lessons from an FDA advisory committee meeting. N Engl J Med. 2007;357(9):844-46.
16. U.S. Food and Drug Administration Center for Drug Evaluation and Research. 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 at: www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4308m1-final.pdf. Accessed December 27, 2007.
17. Avandia (rosiglitazone) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2007.
18. U.S. Food and Drug Administration. Label and approval history for Januvia. Available at: www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist. Accessed June 13, 2008.
19. U.S. Food and Drug Administration. Label and approval history for Janmet. Available at: www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist. Accessed June 13, 2008.
20. Saul S. VA is limiting use of diabetes drug. New York Times. October 18, 2007. Available at: www.nytimes.com/2007/10/18/business/ 18drug.html?ex=1350360000&en=06879a6ee6369532&ei= 5088&partner=rssnyt&emc=rss. Accessed June 13, 2008.
21. Gleason PP, Walters C, Heaton AH, Schafer JA. Telithromycin: the perils of hasty adoption and persistence of off-label prescribing. J Manag Care Pharm. 2007;13(5):420-25. Available at: www.amcp.org/data/jmcp/ JMCPMaga_June%2007_p420-425.pdf.
22. Wilkinson JJ, Force RW, Cady PS. Impact of safety warnings on drug utilization: marketplace life span of cisapride and troglitazone. Pharmacotherapy. 2004;24:978-86.
23. Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G. Triple therapy in type 2 diabetes. Insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naïve patients. Diabetes Care. 2006;29:554-59.
24. Reuters. Two U.S. healthcare providers drop Glaxo's Avandia. Available at: www.reuters.com/article/idUSL0626857620071206. Accessed December 13, 2007.
25. Birman-Deych E, Waterman AD,Yan Y, et al. Accuracy of ICD-9-CM codes for identifying cardiovascular and stroke risk factors. Med Care. 2005;43:480-85.
26. FDA News. FDA issues safety alert on Avandia. Available at: www.fda.gov/ bbs/topics/NEWS/2007/NEW01636.html. Accessed June 13, 2008.
27. FDA News. Manufacturers of some diabetes drugs to strengthen warning on heart failure risk. Available at: www.fda.gov/bbs/topics/NEWS/2007/ NEW01683.html. Accessed June 13, 2008.
28. FDA. Information for healthcare professionals. Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl). Available at: www.fda.gov/cder/drug/InfoSheets/HCP/rosigtitazone200707HCP.htm#2007_5. Accessed June 13, 2008.