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Previous Volume 357:844-846 August 30, 2007 Number 9 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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On July 30, 2007, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) convened to discuss the myocardial ischemic risk associated with rosiglitazone treatment in patients with type 2 diabetes mellitus. The joint committee, which I chaired, consisted of 24 experts in cardiovascular disease, epidemiology, biostatistics, and endocrinology. After lengthy discussions, we concluded that the use of rosiglitazone for the treatment of type 2 diabetes was associated with a greater risk of myocardial ischemic events than placebo, metformin, or sulfonylureas.

That conclusion was based primarily on . . . [Full Text of this Article]

Source Information

Dr. Rosen is an endocrinologist and a senior staff scientist at the Maine Center for Osteoporosis, St. Joseph Hospital, Bangor, and the Jackson Laboratory, Bar Harbor — both in Maine.

This article (10.1056/NEJMp078167) was published at www.nejm.org on August 8, 2007.

Related Letters:

Rosiglitazone and the FDA
Joffe H. V., Parks M. H., Meyer R. J., Jenkins J. K., Temple R., Krall R. L., Rosen C. J.
Extract | Full Text | PDF  
N Engl J Med 2007; 357:1775-1777, Oct 25, 2007; published at www.nejm.org on Aug 29, 2007 (10.1056/NEJMc076347). Correspondence

Rosiglitazone and the FDA
Joffe H. V., Parks M. H., Meyer R. J., Jenkins J. K., Temple R., Krall R. L., Rosen C. J.
Extract | Full Text | PDF  
N Engl J Med 2007; published at www.nejm.org on Aug 29, 2007 (10.1056/NEJMc076347). Correspondence

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