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#45: Clopidogrel pharmacogenomics: Challenges, controversies, and clinical implications with Dr Jessica Mega

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The issue of clopidogrel genomics and CYP2C19 genotyping came to a head with the recent JAMA meta-analysis that questioned the use of clopidogrel loss-of-function gene testing—controversially stating that there is no link between genotype and cardiovascular events. Dr Jessica Mega joins the show to shine light on the rapidly evolving field of clopidogrel pharmacogenomics, examine the scientific data—and the controversy—and share her recommendations for practitioners.

See also:

Holmes MV, Perel P, Shah T, et al. CYP2C19 genotype, clopidogrel metabolism, platelet function, and cardiovascular events. JAMA 2011; 306:2704-2714. Available here.

Analysis slams use of clopidogrel loss-of-function gene test; proponents fire back

An important miscue in clopidogrel pharmacogenomics

ELEVATE-TIMI 56: Clopidogrel 225 mg for patients with one loss-of-function allele

GRAVITAS gene study: CYP2C19*2 carriers do not respond to high-dose clopidogrel

Dr Mega has served as an advisor or consultant for AstraZeneca, Bristol-Myers Squibb, Gilead, Merck, and Sanofi-Aventis. She has received grants for clinical research from Accumetrics, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Johnson & Johnson, Nanosphere, Sanofi-Aventis, and Eli Lilly.

For Dr Harrington's disclosures, click here.

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I very much enjoyed Dr. Mega's interview. Clear and concise. Well balanced. I would like to point out that we have initiated the Pharmacogenomics of Anti-Platelet-2 (PAPI-2) Trial. This is a large NIH-funded randomized clinical trial comparing genotype-directed anti-platelet therapy to standard of care anti-platelet therapy (see ClinicalTrials.gov NCT01452152). Our hope is that this study will provide the evidence base to determine whether genotype-directed therapy is efficious and cost-effective. 
Posted by Alan Shuldiner, MD, Mar 01, 2012 at 04:45 PM, EDT
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About The Bob Harrington Show
In his series of discussions, Bob Harrington provides valuable context to news and topics in cardiology by seeking the counsel of thought leaders at the heart of the event. New episodes are published on a monthly basis and are available on both theheart.org and iTunes.
About Robert A Harrington MD
Dr Harrington is the director of the Duke Clinical Research Institute (DCRI) and professor of medicine at Duke University Medical Center, where he practices interventional cardiology.

Dr Harrington's research interests include evaluating antithrombotic therapies to treat acute ischemic heart disease and minimize the acute complications of percutaneous coronary procedures, studying the mechanism of disease of acute coronary syndromes, understanding the issues of risk stratification in the care of patients with acute ischemic coronary syndromes, and trying to better understand and improve upon the methodology of clinical trials.

Author of multiple peer-reviewed manuscripts, reviews, book chapters, and editorials, he was one of the senior coeditors for the 8th edition of the American College of Chest Physicians' Consensus Panel on Antithrombotic and Thrombolytic Drugs. Dr Harrington is an associate editor of the American Heart Journal and an editorial board member for the Journal of the American College of Cardiology. He is a fellow of the ACC, AHA, SCAI, ACCP, and ESC and is a member of the board of trustees of the ACC. He recently served as chair of the FDA Cardiovascular and Renal Drugs Advisory Committee.

When not focusing on acute coronary syndromes, Dr Harrington dreams of being a radio commentator for the Boston Red Sox.