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.
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
Mehul
M
Desai
Norman
N
Stockbridge
Robert
R
Temple
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