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Name:
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NATALIE DEMO
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Date of Birth:
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Coriell ID:
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DEMONAT
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Lab Accessioning Number:
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DEMONAT
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Ordering Physician:
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Gender:
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Female
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Date Collected:
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Date Received:
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Date of Report:
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04/29/2011
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CYP2C19 and clopidogrel (Plavix®) Response
These results were generated in a CLIA-approved laboratory as part of the Coriell
Personalized Medicine Collaborative research study. Results take into account 8
genetic variants in the CYP2C19 gene, known to contribute to the metabolism of clopidogrel
(Plavix®). This report reflects this participant’s metabolism status
predicted based on genetic testing but does not reflect whether they are currently
taking clopidogrel (Plavix®).
The CPMC has genetic counselors and pharmacists available to assist with report
interpretation at no charge. For questions please contact us at cpmcgc@coriell.org
or by phone at 888-580-8028. Participants may schedule an appointment with one of
our board-certified genetic counselors or pharmacists by logging into their web
portal account and clicking on "request an appointment". For general information
about the CPMC please visit our website cpmc.coriell.org.
This research report includes all data included in the clinical report as well as
supplemental drug specific interpretations and educational material. Please see
the report that follows for the official clinical report.
Your combination of genetic variant results (listed below in yellow) is commonly
referred to as:
CYP2C19*4/*4 (Clopidogrel Poor Metabolizer)
| VARIANTS TESTED | YOUR RESULT | REFERENCE VALUE |
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rs12248560
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CC
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C C
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rs28399504
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GG
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A A
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rs41291556
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TT
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T T
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rs72558184
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GG
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G G
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rs4986893
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GG
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G G
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rs4244285
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GG
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G G
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rs72558186
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TT
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T T
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rs56337013
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CC
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C C
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Other variants, not currently included in this CPMC test may influence this result
and interpretation.
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Poor metabolizers have significantly decreased CYP2C19 activity.
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Poor metabolizers are not likely to benefit from taking clopidogrel and may be at increased risk for blood clots, heart attack or stroke.
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Talk to your doctor about alternative medications.
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This result may also affect your response to other medications. For more information on other medications that are affected by the CYP2C19 gene, click here.
Genetic Risk Factors
Genetic variants, or changes, in a gene called CYP2C19 can affect the way your body
metabolizes clopidogrel.
Some people with certain genetic variants may not benefit as much from taking clopidogrel
compared to people without these variants. These people can be at increased risk
for heart attacks or blood clots.
Non-Genetic Risk Factors
Many factors affect how your body responds to medications.
Non-genetic factors include: diet, lifestyle, medical history and interactions between
medications.
Genes Affecting Clopidogrel Metabolism:
CYP2C19
Types of Variants in CYP2C19
There are many variants in the CYP2C19 gene. A number system has been created to
name common combinations of variants. Some variant combinations have not been assigned
a number yet. Other combinations of variants cannot be assigned a number with certainty.
We all have 2 copies of every gene; when possible, you will have a CYP2C19 result
with two numbers.
Example: CYP2C19 *1/*2
Your personal result can be found by clicking on
the RESULTS tab.
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Reduced CYP2C19 activity
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Poor Metabolizer
3
out of 100 people
Not likely to receive full benefit of clopidogrel. Increased risk for heart attack
and stroke.
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Intermediate Metabolizer
20
out of 100 people
May not receive full benefit of clopidogrel. Possible increased risk for heart
attack and stroke.
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Typical CYP2C19 activity
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Extensive Metabolizer
29
out of 100 people
Expected to benefit from standard clopidogrel dose.
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Increased CYP2C19 activity
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Ultra-Rapid Metabolizer
38
out of 100 people
Expected to process medication more quickly. Possible increased benefit. Possible
increased risk for bleeding.
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Uncertain CYP2C19 activity
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Metabolizer Status Unknown
10
out of 100 people
Not enough data to determine clopidogrel response.
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The following medications, when taken with clopidogrel, may reduce the benefit of
clopidogrel or increase the risk for side effects:
| Medication | Also Known As |
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Omeprazole
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Prilosec, Zegerid
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Warfarin
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Coumadin, Athrombin
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Nonsteroidal anti-inflammatory drugs (NSAIDs)
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aspirin, ibuprofen, acetaminophen, naproxen
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For a selected list of other medications that can also affect your response to clopidogrel,
click here.
Share these results with your healthcare providers.
Print Report
DO NOT MAKE CHANGES TO ANY MEDICATION WITHOUT TALKING TO YOUR HEALTHCARE PROVIDERS.
Result Limitations
- This result alone does NOT predict your total response to clopidogrel.
- Other factors such as body weight, various health conditions, and other medications
may impact an individual’s response to clopidogrel.
- There may be other genetic variants within the CYP2C19 gene which influence response
to clopidogrel but are not included in this test.
- There may be other genetic variants in the CYP2C19 gene for which response to clopidogrel
has not been documented and/or validated in multiple studies.
- There may be genetic variants in other genes that influence response to clopidogrel.
- This result reflects published data available at the time this gene-drug pair was
approved by the CPMC Informed Cohort Oversight Board (12-8-10). The information
provided may change as new scientific information becomes available.
- Although rare, it is possible that you may receive an incorrect result; 100% accuracy
of reported results cannot be guaranteed.
- Occasionally there may be a specific variant on a gene chip that is not able to
be read or interpreted. In this case you will not receive a result for that variant.
It is expected that you will receive results for about 95% of variants approved
by the Pharmacogenetics Advisory Group (PAG) and Informed Cohort Oversight Board (ICOB).
- Every effort will be made to provide you with risk information based on your reported
race/ethnicity. However, data may not be available for all races/ethnicities. Please
see your individual results to determine which race/ethnicity the data is based
on.
Test Limitations
DNA-based testing is highly accurate, however there are many sources of potential
error including: mis-identification of samples, rare technical errors, trace contamination
of PCR reactions, and rare genetic variants that interfere with analysis. This test
or one or more of its components was developed and its performance characteristics
determined by the Coriell Institute for Medical Research. It has not been approved
by the Food and Drug Administration (FDA). The FDA has determined that such approval
is not necessary. The Coriell Institute is regulated under the Clinical Laboratory
Improvement Amendments (CLIA) of 1988 as qualified to perform high-complexity testing.
Methods
References
- Chen BL, et al. Clin Exp Pharmacol Physiol.2008;35(8):904‐8.
- Collet JP, et al. The Lancet. 2009;373(9660):309‐317.
- Ferguson RJ, et al. J Pharmacol Exp Ther. 1998;284(1):356‐61.
- Giusti B, et al. Am J Cardiol. 2009; 103(6):806–811.
- Gladding P, et al. JACC Cardiovasc Interv. 2008;1(6):620‐7.
- Ibeanu GC, et al. Pharmacogenetics. 1998;8(2):129‐35.
- Ibeanu GC, et al. J Pharmacol Exp Ther. 1998;286(3):1490‐5.
- Ibeanu GC, et al. J Pharmacol Exp Ther. 1999;290(2):635‐40.
- Mega JL, et al. N Engl J Med. 2009;360(4):354‐62.
- Mega JL, et al. JAMA. 2010;304; 1821-1830.
- Paré G, et al. NEJM. 2010 Aug 29; online.
- Rogan PK, et al. Pharmacogenetics. 2003;13(4):207‐18.
- Shuldiner AR, et al. JAMA. 2009;302(8):849‐57.
- Sibbing D, et al. Eur Heart J. 2009;30(8):916‐22.
- Sibbing D, et al. Circulation. 2010;121(4):512‐8.
- Sim SC, et al. Clin Pharmacol Ther. 2006;79(1):103‐13.
- Simon T, et al. N Engl J Med. 2009;360(4):363‐75.
- Tiroch KA, et al. Am Heart J. 2010 Sep;160(3):506‐12.
- Trenk D, et al. J Am Coll Cardiol. 2008;51(20):1925‐34.
- Varenhorst C, et al. Eur Heart J. 2009;30(14):1744‐52.
- Wallentin L, et al. Lancet. 2010 Aug 27. [Epub ahead of print]
Test Methodology
Saliva samples were collected using Oragene DNA Collection Kits (DNA Genotek) and
DNA was extracted manually according to the manufacturer’s instructions or automatically
using a DNAdvance Kit (Agencourt). Purified DNA was quantified using UV absorbance
at 260 nm. One microgram of the resulting DNA from each sample was used as template
in the Affymetrix DMET Plus GeneChip assay. Data analysis was performed using Affymetrix
DMET Console software.
To view your clinical report,
click here.
The clinical report contains the lab generated testing information and does not
include all the content in the research study report.
[Risk interpretation based on Coriell's CYP2C19 Clopidogrel Metabolizer Type Genotype Translation Version
1
(March 2011)]
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