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Volume 359:1092-1095 September 11, 2008 Number 11
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Assessing the Cardiovascular Safety of Diabetes Therapies
Allison B. Goldfine, M.D.

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The Endocrinologic and Metabolic Drugs Advisory Committee for the Food and Drug Administration (FDA), of which I am a member, convened in early July to consider whether data on long-term cardiovascular safety should be required for new and existing therapies for type 2 diabetes mellitus, whether trials should merely rule out harm or must show cardiovascular benefit, and at what point in the drug-approval process and by what methods cardiovascular data should be obtained.

Clinical treatment goals for patients with type 2 diabetes include alleviating acute symptoms of hyperglycemia and forestalling diabetes-related complications. Drugs that are approved by the FDA . . . [Full Text of this Article]


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Dr. Goldfine is head of the Section on Clinical Research at the Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School — both in Boston.




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