Blood pressure as an example of a biomarker that functions as a surrogate.
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.
Desai
Mehul
M
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
Stockbridge
Norman
N
Temple
Robert
R
D000818:Animals; D001794:Blood Pressure / Q000187:drug effects* / Q000502:physiology*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D006973:Hypertension / Q000139:chemically induced / Q000175:diagnosis* / Q000401:mortality / Q000503:physiopathology