AstraZeneca Announces Top Line Results From Pivotal Phase III Study for BRILINTA
AstraZeneca has announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus clopidogrel, in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death.
In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the phase II studies. Given the size of the PLATO trial, further analysis of the entire database, secondary variables, and subgroups is ongoing. AstraZeneca and the PLATO Executive Committee's aim is to submit the PLATO data to a peer-reviewed medical journal and present at the European Society of Cardiology (ESC) annual meeting in August 2009.
It is estimated that one in three ACS patients will die, have a recurrent heart attack (also known as myocardial infarction), or be readmitted to hospital within six months of their first cardiovascular event so preventing reoccurrence is vital in ACS patient treatment.
PLATO was a head-to-head outcomes study of BRILINTA versus clopidogrel to establish whether BRILINTA could achieve meaningful cardiovascular and safety endpoints in ACS patients. The study involved 18,624 ACS patients in 43 countries and was designed to provide a comprehensive analysis of efficacy, safety and tolerability of BRILINTA. The PLATO study was led by the Executive Committee co-chairs, Professor Lars Wallentin, Sweden (Uppsala Clinical Research Center) and Professor Robert Harrington, USA (Duke Clinical Research Institute).
The submission of BRILINTA to regulatory authorities remains on schedule for the fourth quarter of 2009.
BRILINTA is the first reversibly binding oral adenosine diphosphate (ADP) receptor antagonist and is chemically distinct from thienopyridines like clopidogrel. It selectively inhibits P2Y12, a key target receptor for ADP. ADP receptor blockade inhibits the action of platelets in the blood, reducing recurrent thrombotic events.
AstraZeneca has proposed the name BRILINTA. If approved by the FDA and the EMEA, it will serve as the trade name for ticagrelor/AZD6140.
BRILINTA is a trademark of the AstraZeneca group of companies.
The study design of PLATO was published in the April 2009 edition of the American Heart Journal (James, S. et al. in Am. Heart J. 2009; 157: 599-605).
BRILINTA Phase II studies include DISPERSE and DISPERSE2. DISPERSE was published by Husted, S. et al. in Eur. Heart J. 2006; 27: 1038–1047. DISPERSE2 was published by Cannon, C.P. et al in J. Am Coll. Cardiol. 2007; 50: 1844-1851 and by Storey, R.F. et al in J. Am. Coll. Cardiol. 2007; 50: 1852-1856
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