Atherosclerosis imaging as a benchmark in the development of novel cardiovasular drugs.
OBJECTIVE
Imaging of the arterial wall yields validated surrogate markers that can provide an early indication with regards to efficacy of novel cardiovascular drugs. This paper attempts to address the use of atherosclerosis imaging as a benchmarking tool for a well informed decision whether to proceed to large morbidity and mortality studies in the assessment of a novel therapeutic strategy.


RESULTS
Imaging of the artery wall can be used to evaluate individual cardiovascular risk and has additive value over conventional risk scores as it directly addresses the disease process. In controlled clinical trials, vascular imaging has shown that the efficacy of lipid-modifying pharmacotherapy can be evaluated in both high and low-risk populations and that the findings parallel outcomes of clinical studies with similar interventions.


CONCLUSIONS
Arterial imaging may provide the first glimpse of the efficacy or failure of a novel strategy to combat atherosclerosis. These findings suggest that vascular imaging could be employed to probe whether or not a large morbidity and mortality endpoint study should be the next step in a clinical development program.
Duivenvoorden
Raphael
R
Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, The Netherlands.
Nederveen
Aart J
AJ
de Groot
Eric
E
Kastelein
John J P
JJ
D000924:Anticholesteremic Agents; D050197:Atherosclerosis / Q000175:diagnosis* / Q000188:drug therapy*; D054316:Biomarkers, Pharmacological; D002317:Cardiovascular Agents; D003952:Diagnostic Imaging / Q000379:methods*; D015195:Drug Design; D006801:Humans
D000924:Anticholesteremic Agents; D054316:Biomarkers, Pharmacological; D002317:Cardiovascular Agents