Use of surrogate endpoints: A practical necessity in lipid-altering and antiatherosclerosis drug development

被引：0
|
作者：
Orloff, DG [1 ]
机构：
[1] US FDA, Rockville, MD 20857 USA
来源：
AMERICAN JOURNAL OF CARDIOLOGY | 2001年 / 87卷 / 4A期
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暂无
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
Apparently favorable effects of antiatherosclerosis drugs as assessed by changes in surrogate markers of cardiovascular disease risk are frequently relied upon for drug approval and labeling. Surrogates must be biologically plausible and adequately validated but are, by definition, imperfect as predictors of ultimate outcome (i.e., serious morbidity and mortality). Surrogate markers utilized in the study of drugs for the treatment of atherosclerotic cardiovascular disease may be classified as laboratory/biochemical, anatomic/morphologic, and functional. The places for various surrogates in all three categories in the development of lipid altering drugs are discussed, (C)2001 by Excerpta Medico, Inc.
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页码：35A / 41A
页数：7
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