Transcript clopidogrel

PhenGene
P2Y12 Test
1
CLOPIDOGREL
•
A second-generation thienopyridine antiplatelet agent, an antagonist of platelet P2Y12 receptor
•
Inhibits the formation of blood clots in the coronary, peripheral & cerebrovascular arteries
METABOLISM AND ACTION OF CLOPIDOGREL
2
Problem – limited effectiveness of clopidogrel
Pharmacodynamic evidence recognized by the FDA, American College of
Cardiology, American Heart Association, and European Society of Cardiology
suggests that clopidogrel has a suboptimal effect in a substantial proportion
(“about one third”) of patients and that increasing the dose has limited efficacy
in selected patients.
Clopidogrel is not effective in about 1/3 of individuals
One of the most prevalent reasons for reduced response to
CLOPIDOGREL is inefficient conversion of the drug into its
active metabolite due to genetic variability in liver enzymes
3
No easy-to-use test for clopidogrel effectiveness
Clopidogrel effectiveness is not routinely measured due to
• current assessment of platelet function requiring testing within a
limited time of taking the blood sample
• specialised equipment and technical expertise requirements on site
• Ineffective treatment can increase the risk of a recurrent cardiac
event or stroke
• Overly effective treatment can lead to excessive bleeding
4
Our Solution
To identify patients who are not responding to Clopidogrel using PhenGene
P2Y12 Test that includes:
• Genotyping: CYP2C19 enzyme
o Involved in the metabolism of clopidogrel
o Every individual has two CYP2C19 alleles
o Depending on the combination of alleles in an individual, drugmetabolizing phenotypes associated with the CYP2C19 enzyme can vary
• Phenotyping: assessing platelet reactivity in response to stimulation with
agonists
o High on-treatment
thrombotic events
platelet
reactivity
correlates
with
recurrent
Blood samples are collected, processed using simple kit and are sent for analysis
at a central laboratory – no need for specialised equipment on site and no time
limitations to perform the analysis
5
Supporting Studies
6
Importance of CYP2C19 Genotyping
In 2009, the US Food and Drug Administration (FDA) issued a
boxed warning, recommending “consideration of CYP2C19
genotype” prior to prescribing clopidogrel.
7
OUR WORKFLOW
Assess anywhere
Sample Collection
& Processing
Sample Shipment
Sample analysed Electronic reporting
Patient on antiplatelet
therapy can be assessed
in primary care or home
setting
Blood sample taken and
processed using simple,
drug-specific kit
Processed sample is
Laboratory staff analyse
shipped to a central
sample for P-selectin
processing lab in the UK
using flow cytometry
and CYP2C19 using
Luminex Platform
Complete test results are
reported back
electronically
8
Advantages of this combined testing
• Identify at risk patients with sub-optimal response to Clopidogrel
using both genotyping and phenotyping approaches
• Results allow healthcare providers tailor the prescription of
antiplatelet agents for their patients accordingly to reduce the risk of
myocardial infarction, stent thrombosis or stroke
• No capital investment is required on site to setup the testing – all
that is needed is an easy-to-use testing kit to process and stabilise the
blood sample, which is then sent for expert analysis to a central
laboratory