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Published at www.nejm.org August 29, 2007 (10.1056/NEJMc076347)

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To the Editor: In his Perspective article (Aug. 30 issue),¹ Dr. Rosen discusses the recent Food and Drug Administration (FDA) advisory committee meeting on rosiglitazone. He also calls for approval of antidiabetic drugs based on long-term clinical outcomes, not on the surrogate of glycated hemoglobin, a measure of glycemic control. Although he does not describe a specific study, we assume he is suggesting that approval should require evidence that cardiovascular events, a major long-term complication of diabetes mellitus, are reduced. This change could have major implications for the availability of treatments for type 2 diabetes.

All drugs currently approved for . . . [Full Text of this Article]

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