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