Use of surrogate endpoints: a practical necessity in lipid-altering and antiatherosclerosis drug development.
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.
Orloff
D G
DG
United States Food and Drug Administration, Rockville, Maryland 20857, USA.
D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic / Q000379:methods; D003324:Coronary Artery Disease / Q000097:blood* / Q000188:drug therapy; D017277:Drug Approval; D004341:Drug Evaluation / Q000379:methods; D006801:Humans; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood*; D015203:Reproducibility of Results
D015415:Biomarkers; D000960:Hypolipidemic Agents; D008055:Lipids