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Published in: Trials 1/2005

Open Access 01-12-2005 | Review

Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors

Authors: Mark A Espeland, Daniel H O'Leary, James G Terry, Timothy Morgan, Greg Evans, Harald Mudra

Published in: Trials | Issue 1/2005

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Abstract

Background

Surrogate measures for cardiovascular disease events have the potential to increase greatly the efficiency of clinical trials. A leading candidate for such a surrogate is the progression of intima-media thickness (IMT) of the carotid artery; much experience has been gained with this endpoint in trials of HMG-CoA reductase inhibitors (statins).

Methods and Results

We examine two separate systems of criteria that have been proposed to define surrogate endpoints, based on clinical and statistical arguments. We use published results and a formal meta-analysis to evaluate whether progression of carotid IMT meets these criteria for HMG-CoA reductase inhibitors (statins).
IMT meets clinical-based criteria to serve as a surrogate endpoint for cardiovascular events in statin trials, based on relative efficiency, linkage to endpoints, and congruency of effects. Results from a meta-analysis and post-trial follow-up from a single published study suggest that IMT meets established statistical criteria by accounting for intervention effects in regression models.

Conclusion

Carotid IMT progression meets accepted definitions of a surrogate for cardiovascular disease endpoints in statin trials. This does not, however, establish that it may serve universally as a surrogate marker in trials of other agents.
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Metadata
Title
Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors
Authors
Mark A Espeland
Daniel H O'Leary
James G Terry
Timothy Morgan
Greg Evans
Harald Mudra
Publication date
01-12-2005
Publisher
BioMed Central
Published in
Trials / Issue 1/2005
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1468-6708-6-3

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