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AAPS J. 2006 Mar 10;8(1):E146-52.

Blood pressure as an example of a biomarker that functions as a surrogate.

Author information

1
Food and Drug Administration, Division of Cardiovascular and Renal Products (HFD-110), Bldg 22, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA. desaim@cder.fda.gov

Abstract

There are many important uses of biomarkers in drug development. An area of particular interest is the use of biomarkers as surrogate end points. Only a small minority of biomarkers are established surrogate end points. Blood pressure is an example of a surrogate end point accepted by both clinicians and regulators. It was a plausible surrogate because of the large epidemiologic databases demonstrating a correlation between elevated blood pressures and adverse cardiovascular outcomes. That plausibility has been supported, however, by the numerous placebo-controlled outcome studies evaluating several pharmacologically distinct agents that showed an effect on stroke and coronary heart disease outcomes from lowering blood pressure.

PMID:
16584122
PMCID:
PMC2751433
DOI:
10.1208/aapsj080117
[Indexed for MEDLINE]
Free PMC Article

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