deCODE Clopidogrel™

Analyzes five SNPs in the CYP2C19 gene that affect response to the anti-platelet drug clopidogrel. This test identifies those who may need adjustment of their clopidogrel dose or who should be put on an alternative medication to prevent recurrent adverse cardiovascular events.

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Personalizing therapy

How deCODE Clopidogrel™ can help.

Detecting carriers of reduced function alleles in the CYP2C19 gene identifies those who have decreased bioconversion of clopidogrel to its active metabolite and a decreased anti-platelet response. As a result, they may be at increased risk of recurrent adverse cardiovascular events despite their anti-platelet drug treatment.

The U.S. Food and Drug Administration (FDA) has added a Boxed Warning to the label for clopidogrel, informing health care providers of the availability of the CYP2C19 genetic test for the identification “poor metabolizers”, for whom other anti-platelet medications or alternative dosing strategies should be considered.

References

For information on indications, dosage, side effects and more, please refer to:

http://www.rxlist.com/plavix-drug.htm References

1. Mega JL, Close SL, Wiviott SD, et al, “Cytochrome P-450 Polymorphisms and Response to Clopidogrel,” N Engl J Med, 2009, 360(4):354-62.PubMed 19106084

2. Trenk D et al. Cytochrome P450 2C19 681G>A polymorphism and high on-clopidogrel platelet reactivity associated with adverse 1-year clinical outcome of elective percutaneous coronary intervention with drug-eluting or bare-metal stents. J Am Coll Cardiol. 2008 May 20;51(20):1925-34.

3. Brandt JT et al. Common polymorphisms of CYP2C19 and CYP2C9 affect the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel. J Thromb Haemost. 2007 Dec;5(12):2429-36. Epub 2007 Sep 26

4. Shuldiner AR, O´Connell JR et al. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of Clopidogrel therapy. JAMA, 2009,302 (8), 855-858

5. Collet J-P, Hulot J-S, Pena A, et al, “Cytochrome P450 2C19 Polymorphism in Young Patients Treated With Clopidogrel After Myocardial Infarction: A Cohort Study,” Lancet, 2009, 373(9660):309-17.PubMed 19108880

6. Simon T, Verstuyft C, Mary-Krause M, et al, “Genetic Determinants of Response to Clopidogrel and Cardiovascular Events,” N Engl J Med, 2009, 360(4):363-75.PubMed 19106083

7. Matetzky S, Shenkman B et al. Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction. Circulation. 2004 Jun 29;109(25):3171-5. Epub 2004 Jun 7

8. Hochholzer W, Trenk D et al. Impact of the degree of peri-interventional platelet inhibition after loading with clopidogrel on early clinical outcome of elective coronary stent placement. J Am Coll Cardiol. 2006 Nov 7;48(9):1742-50. Epub 2006 Oct 17.

9. Mega JL, Close SL et al Genetic variants in ABCB1 and CYP2C19 and cardiovascular outcomes after treatment with clopidogrel and prasugrel in the TRITON-TIMI 38 trial: a pharmacogenetic analysis. Lancet. 2010 Oct 16;376(9749):1312-9.

10. Guillaume Paré, M.D., Shamir Ret al.Effects of CYP2C19 Genotype on Outcomes of Clopidogrel Treatment. N Engl J Med 2010; 363:1704-171.

11. Wallentin L, James S, Storey RF, et al. Effect of CYP2C19 and ABCB1 single nucleotide polymorphisms on outcomes of treatment with ticagrelor versus clopidogrel for acute coronary syndromes: a genetic substudy of the PLATO trial. Lancet. 2010 Oct 16;376(9749):1320-8.

12. Desta Z, Zhao X, Shin JG, Flockhart DA. Clinical significance of the cytochrome P450 2C19 genetic polymorphism. Clin Pharmacokinet. 2002;41(12):913-58. Review

13. Sibbing D, Koch W, Gebhard D, et al, “Cytochrome 2C19*17 Allelic Variant, Platelet Aggregation, Bleeding Events, and Stent Thrombosis in Clopidogrel-Treated Patients With Coronary Stent Placement,” Circulation, 2010, 121(4):512-8.PubMed 20083681

14. Mega JL, Simon T, et al.Reduced-function CYP2C19 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI: a meta-analysis. JAMA. 2010 Oct 27;304(16):1821-30.

15. Holmes DR Jr, Dehmer GJ, et al. ACCF/AHA clopidogrel clinical alert: approaches to the FDA ‘boxed warning’: a report of the American College of Cardiology Foundation Task Force on clinical expert consensus documents and the American Heart Association endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2010 Jul 20;56(4):321-41.