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

被引:50
作者
Desai, M [1 ]
Stockbridge, N [1 ]
Temple, R [1 ]
机构
[1] US FDA, Div Cardiovasc & Renal Prod, Silver Spring, MD 20993 USA
关键词
biomarker; surrogate endpoint; blood pressure;
D O I
10.1208/aapsj080117
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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 be cause 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.
引用
收藏
页码:E146 / E152
页数:7
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