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March 25, 2012

AstraZeneca reports sub-analysis outcomes from PLATO study

AstraZeneca has reported the results from a sub-analysis of the PLATO genetic sub-study that evaluated the impact of poor metabolisers of clopidogrel in patients with acute coronary syndrome (ACS).

AstraZeneca has reported the results from a sub-analysis of the PLATO genetic sub-study that evaluated the impact of poor metabolisers of clopidogrel in patients with acute coronary syndrome (ACS).

Brilinta is a reversibly binding oral platelet P2Y12 adenosine diphosphate (ADP) receptor antagonist that has been shown to reduce the rate of thrombotic cardiovascular (CV) events in patients with ACS.

The PLATO trial was a large 18,624-patient head-to-head outcomes study, designed to demonstrate whether Brilinta (ticagrelor) could achieve a clinically meaningful reduction in CV end points in ACS patients when compared to clopidogrel.

The study demonstrated that treatment with Brilinta showed greater reduction in the primary end point, a composite of CV death, myocardial infarction (MI), or stroke compared to patients who received clopidogrel.

The PLATO study also reported that treatment with Brilinta for 12 months was associated with a 21% relative risk reduction (RRR) in CV death and a 16% RRR in MI compared to clopidogrel at 12 months.

In the sub-analysis, 10,285 DNA samples from patients in the PLATO trial underwent CYP2C19 genotyping for wildtype (*1), LOF alleles *2, *3, *4, *5, *6, *7, & *8; and gain of function allele *17.

AstraZeneca Brilinta clinical development executive director Alex Gold said the study data suggested that the results in PLATO were not driven by the poor metabolisers of clopidogrel.

"In the analysis, after excluding poor metabolisers, the remaining majority of patients showed a result consistent with the overall outcome of the PLATO study," Gold added.

Brilinta is available in 90mg tablets to be administered with a single 180mg oral loading dose followed by a twice daily, 90mg maintenance dose.

AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease.

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