Review: Biomarkers in clinical trials and drug development: measurement of cardiometabolic risk

Abstract

Cardiometabolic risk is linked to a cluster of modifiable factors, including established risk factors such as obesity, dyslipidaemia, raised blood pressure, and 'nontraditional' risk factors closely related to central (especially intra-abdominal) adiposity. These 'nontraditional' risk factors include dysfunction of inflammation, coagulation, platelets, fibrinolysis, lipoproteins, endothelium, plaque instability, and miscellaneous biological processes. Both the established ('traditional') and emerging ('nontraditional') cardiometabolic risk factors are components of the metabolic syndrome. In patients with known or suspected cardiometabolic diseases, biomarkers are increasingly being explored as indicators of disease presence, severity or activity, prognosis and therapeutic efficacy. Many biomarkers have been proposed for prediction of the macrovascular (and microvascular) complications of cardiometabolic diseases. This review provides background information on biomarkers, and an assessment of the possible utility of biomarkers in clinical trials and drug development programmes that include measurement of cardiometabolic risk.