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DOI: 10.2337/dc07-zb09
© 2007 by the American Diabetes Association
Reviews/Commentaries/ADA Statements |
The Avandia Debate
Zachary T. Bloomgarden, MD, is a practicing endocrinologist in New York, New York, and is affiliated with the Division of Endocrinology, Mount Sinai School of Medicine, New York, New York
Abbreviations: ADA, American Diabetes Association • CVD, cardiovascular disease • DREAM, Diabetes REduction Assessment with ramipril and rosiglitazone Medication • FDA, Food and Drug Administration • FFA, free fatty acid • GSK, GlaxoSmithKline • IMT, intima-medial thickness • TZD, thiazolidinedione
| The first 300 words of the full text of this article appear below. |
Perspectives on the News commentaries are now part of a new, free monthly CME activity. The Mount Sinai School of Medicine, New York, New York, is designating this activity for 2.0 AMA PRA Category 1 credits. If you wish to participate, review this article and visit www.diabetes.procampus.net to complete a posttest and receive a certificate. The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
This is the first in a series of articles based on presentations at the American Diabetes Association's (ADA's) 67th Scientific Sessions in June 2007, in Chicago, reviewing aspects of thiazolidinediones (TZDs) treatment, with focus on the controversy over possible adverse effects of rosiglitazone.
On 21 May 2007, an article appeared on the New England Journal of Medicine Web site giving a meta-analysis of 42 trials comparing rosiglitazone with placebo or other agents. Steven Nissen and Kathy Wolski reported a significant 43% increase in myocardial infarction and a trend almost achieving statistical significance of a 64% increase in cardiovascular mortality (1). In an accompanying editorial, Bruce Psaty and Carl Furberg strongly questioned the wisdom of choosing treatments for diabetes based on "the single dimension of glycemic control," suggesting that although "high levels of glycated hemoglobin increase risk," one must "require proof of health benefits" before accepting that an agent lowering blood glucose benefits individuals with diabetes (2).
These articles were accompanied by tremendous publicity. On 22 May 2007, an article in the New York Times entitled "Heart Attack Risk Seen in Drug for Diabetes" summarized the public concern. The article questioned whether GlaxoSmithKline (GSK), the manufacturer of rosiglitazone, and the Food and Drug Administration (FDA) should have released similar data earlier, mentioned investigations being started in Congress,
Debate: Should TZDs be primary agents in the treatment of type 2 diabetes?
Debate: Is rosiglitazone particularly associated with adverse outcome?
Further considerations
FDA advisory panel recommendations
Additional TZD presentations
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  J. Odom, B. Williamson, and L. Carter Rosiglitazone and pioglitazone in the treatment of diabetes mellitus Am. J. Health Syst. Pharm., October 1, 2008; 65(19): 1846 - 1850. [Full Text] [PDF]
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 Z. T. Bloomgarden Cardiovascular Disease in Diabetes Diabetes Care, June 1, 2008; 31(6): 1260 - 1266. [Full Text] [PDF]
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 A. H Barnett Thiazolidinediones and cardiovascular outcomes The British Journal of Diabetes & Vascular Disease, January 1, 2008; 8(1): 45 - 49. [Abstract] [PDF]
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R. I. Misbin Lessons From the Avandia Controversy: A new paradigm for the development of drugs to treat type 2 diabetes Diabetes Care, December 1, 2007; 30(12): 3141 - 3144. [Full Text] [PDF]
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