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Analysis does not support genetic test before use of anti-clotting drug
Date:12/27/2011

rted individuals exposed to clopidogrel ("treatment-only" design). In treatment-only analysis, individuals with 1 or more CYP2C19 alleles (an alternative form of a gene) associated with lower enzyme activity had lower levels of active clopidogrel metabolites, less platelet inhibition, lower risk of bleeding, and higher risk of CVD events. However, there was evidence of small-study bias, the authors write. When analyses were restricted to studies with 200 or more events, the point estimate was lessened.

In effect-modification studies, CYP2C19 genotype was not associated with modification of the effect of clopidogrel on CVD end points or bleeding. A limitation included selective outcome reporting.

"Despite associations between CYP2C19 genotype, clopidogrel metabolism, and platelet aggregation, this systematic review and meta-analysis does not demonstrate a clinically important association of genotype with cardiovascular outcomes with the possible exception of stent thrombosis," the researchers write.

"Our appraisal has identified issues pertaining to the design and analysis of pharmacogenetic studies that are important in the understanding of the significance of the CYP2C19 genotype."

(JAMA. 2011;306[24]:2704-2714. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Pharmacogenomics and Clopidogrel - Irrational Exuberance?

Steven E. Nissen, M.D., of the Cleveland Clinic Foundation, writes in an accompanying editorial that several factors led to the unrealistic expectations of the effectiveness of CYP2C19 genotyping for clopidogrel, and that a large randomized controlled trial is needed to adequately test the clopidogrel pharmacogenomic hypothesis.

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Contact: Michael V. Holmes, M.B.B.S., M.Sc.
mvholmes@gmail.com
JAMA and Archives Journals
Source:Eurekalert

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