AccuType® CP: Clopidogrel Response Testing

For some patients, the only indication of poor clopidogrel response to PLAVIX® (clopidogrel bisulfate) may be an atherothrombotic event, such as a heart attack or stroke. AccuType CP enables early identification of patients who are predisposed to poor therapy response.

PLAVIX is indicated for the reduction of atherothrombotic events for patients with a history of recent myocardial infarction, stroke, or established peripheral arterial disease, as well as patients who are to be managed with percutaneous coronary intervention.1 It is marketed in the U.S. under the trade name PLAVIX by Bristol-Myers Squibb and Sanofi-Aventis pharmaceuticals.2

PLAVIX and Genotyping: Statements from the FDA

The FDA required the following Black Box Warning for PLAVIX on March 12, 2010.3 4

  • “Effectiveness of PLAVIX depends on activation to an active metabolite by the Cytochrome P450 (CYP) system, principally CYP2C19
  • Poor metabolizers treated with PLAVIX at recommended doses exhibit higher cardiovascular event rates following acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) than patients with normal CYP2C19 function
  • Tests are available to identify a patient’s CYP2C19 genotype and can be used as an aid in determining therapeutic strategy
  • Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers”

How Clopidogrel Works

  • Clopidogrel is a “pro-drug” that requires transformation in the liver into an active drug metabolite1
  • This transformation is mediated by cytochrome P450 2C19 enzymes under control of the CYP2C19 gene
  • “Active” clopidogrel metabolites inhibit platelet aggregation

AccuType CP can provide important information to help you determine if alternative medications should be prescribed for:

  • Patients currently on clopidogrel where genotype is unknown
  • Patients with a recent cardiac event despite treatment with clopidogrel

AccuType CP complements other clopidogrel testing methods that may require patients to be on the drug before you can determine the drug’s effectiveness.

Distinct Advantages of AccuType CP Testing
These five
variants
(*2-*5 and *17)
AccuType CP detects 99% of reduced function
metabolizers in Asians and 90% in Caucasians
Individualized
treatment
AccuType CP provides you with relevant information to
help you choose the right therapeutic course for your patients

 

Our genetic counselors can provide additional assistance with AccuType CP results interpretation. Call 1-866-GENE-INFO (1-866-436-3463).

 

References

  1. Bristol-Myers Squibb and Sanofi-Aventis. PLAVIX Web site. May 2010. Available at http://www.plavix.com/hcp/indications/index.aspx. Accessed September 1, 2010.
  2. Bristol-Myers Squibb and Sanofi-Aventis. PLAVIX Web site. May 2010. Available at http://www.plavix.com/Index.aspx. Accessed September 1, 2010.
  3. Food and Drug Administration press release. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm204253.htm. Accessed September 1, 2010.
  4. Bristol-Myers Squibb and Sanofi-Aventis. PLAVIX Prescribing Information. Available at http://products.sanofi-aventis.us/PLAVIX/PLAVIX.html. Accessed September 1, 2010.

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