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0031-6997/07/5901-40-53$7.00
Pharmacol Rev 59:40-53, 2007

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Biomarkers in the Prevention and Treatment of Atherosclerosis: Need, Validation, and Future

James H. Revkin, Charles L. Shear, Hubert G. Pouleur, Steven W. Ryder and David G. Orloff

Pfizer Global Research and Development, New London, Connecticut (J.H.R., C.L.S., H.G.P., S.W.R.); and Medpace Inc., Cincinnati, Ohio (D.G.O.)

Abstract
I. Introduction
II. Definitions
III. Validation of New Surrogate Markers
    A. Quantitative Coronary Angiography
    B. Carotid B-Mode Ultrasound
    C. Coronary Intravascular Ultrasound
IV. Correlation between Carotid Intima-Media Thickness, Intravascular Ultrasound, and Clinical Events
V. Circulating Biomarkers
VI. Surrogate Endpoints and Regulatory Approval
VII. Future Prospects: Biomarkers and Surrogate Endpoints
Cardiovascular disease (CVD) remains one of the leading causes of morbidity and mortality in the developed world, and there is a clear need to develop novel therapeutic strategies to reduce cardiovascular risk further than is currently possible. Traditionally, the effectiveness of new cardiovascular drugs has been evaluated in clinical trials using cardiovascular outcomes as endpoints. However, such trials require large numbers of patients followed over long periods of time. Clinical trials using surrogate markers for CVD may be shorter in duration and involve fewer participants. Measurement of atherosclerotic progression is an ideal surrogate marker as it is predictive of future cardiovascular events. The "gold standard" for detecting and defining the severity, extent, and rate of atherosclerotic progression has been quantitative coronary angiography. However, this technique has fundamental limitations. More recently, measurement of carotid intima-media thickness using B-mode ultrasound and measurement of atheroma volume using intravascular ultrasound have emerged as more accurate techniques for detecting atherosclerotic progression. Both of these techniques have potential utility as surrogate endpoints in place of cardiovascular outcomes in clinical trials. Their use might facilitate the more rapid development of novel, safe, and effective therapies.

Address correspondence to: Dr. James H. Revkin, Director, Pfizer Global Research and Development, 50 Pequot Ave., Mailstop-6025-A4115, New London, CT 06320. E-mail: james.h.revkin{at}pfizer.com






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