Journal
NUTRITION REVIEWS
Volume 66, Issue 2, Pages 76-81Publisher
OXFORD UNIV PRESS INC
DOI: 10.1111/j.1753-4887.2007.00010.x
Keywords
biomarkers; cardiovascular disease; health claims; surrogate endpoint
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This article reviews surrogate endpoints and emerging biomarkers that were discussed at the annual Cardiovascular Biomarkers and Surrogate Endpoints symposium cosponsored by the US Food and Drug Administration (FDA) and the Montreal Heart Institute. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) uses surrogate endpoints in its scientific review of a substance/disease relationship for a health claim. CFSAN currently recognizes three validated surrogate endpoints: blood pressure, blood total cholesterol, and blood low-density lipoprotein (LDL) concentration in its review of a health claim for cardiovascular disease (CVD). Numerous potential surrogate endpoints of CVD are being evaluated as the pathophysiology of heart disease is becoming better understood. However, these emerging biomarkers need to be validated as surrogate endpoints before they are used by CFSAN in the evaluation of a CVD health claim. (c) 2008 International Life Sciences Institute.
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