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

AAPS J. 2006 Mar 10;8(1):E146-52. doi: 10.1208/aapsj080117.

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.

Publication types

  • Review

MeSH terms

  • Animals
  • Blood Pressure / drug effects*
  • Blood Pressure / physiology*
  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Hypertension / chemically induced
  • Hypertension / diagnosis*
  • Hypertension / mortality
  • Hypertension / physiopathology