Monday, 16 November 2009
AstraZeneca today announced results of a PLATO sub-analysis in the most serious type of Acute Coronary Syndrome (ACS) patients, those with ST Segment Elevation Myocardial Infarction (STEMI). In this setting, ST segment elevation indicates total obstruction of a coronary artery which warrants emergency surgery with angioplasty, a procedure termed primary Percutaneous Coronary Intervention or “PCI,” in order to restore flow, salvage the heart muscle (myocardium) from infarction and reduce mortality.
The sub-analysis showed that, compared to clopidogrel (Plavix/Iscover), treatment with ticagrelor (BRILINTA) resulted in a reduction of cardiovascular events (composite of CV death, heart attack and stroke) for up to a year (ticagrelor vs. clopidogrel, 9.3% vs. 11.0%, P=0.02), without an increase in major bleeding (9.0% vs. 9.3%, P=0.63). These efficacy findings were driven by a statistically significant reduction in heart attacks (myocardial infarction) (4.7% vs. 6.1%, P=0.01). For these STEMI patients, the benefit observed with ticagrelor increased over time.
Ticagrelor also demonstrated effects across several secondary efficacy endpoints including, MI, stent thrombosis, and the composite of MI, stroke and all-cause mortality. There was an 18% relative reduction in all cause mortality at one year from 6.0 to 4.9% (P=0.04) with ticagrelor over clopidogrel.
The pre-specified sub-analysis of the ACS STEMI patients looked at approximately 45% (8,430 patients) of the overall PLATO study population. These data were presented today during the late-breaker session at the annual American Heart Association (AHA) Scientific Sessions in Orlando, FL.
“Patients with STEMI need to undergo emergency PCI. They are particularly at risk of serious complications, so also require rapidly active antithrombotic agents,” commented Professor Gabriel Steg, Cardiologist at Hopital Bichat, Assistance Publique - Hôpitaux de Paris (AP-HP), Professor of Cardiology at the University Paris 7, Paris, France and Principal Investigator of the PLATO STEMI sub-analysis. “In PLATO, we studied a broad patient population to investigate ticagrelor’s efficacy in patients that are typical of those we see in clinical practice. As previously shown in patients undergoing invasive procedures, and now in STEMI patients, these results are consistent with the reduction of CV events without an increase in major bleeding, seen in the overall PLATO trial”.
NOTES TO EDITORS:
About ACS STEMI
There are three types of ACS events: ST Segment Elevation Myocardial Infarction (STEMI) usually reflecting complete blockage of coronary artery, non-ST Segment Myocardial Infarction (N-STEMI), usually reflecting partial blockage of coronary artery, and unstable angina. Patients with STEMI represent a high-risk subgroup of ACS patients and a large number of these patients will undergo rapid PCI treatment and are particularly at risk of serious, and potentially deadly, complications.
About PLATO STEMI sub-analysis
In the PLATO study, 4,201 STEMI patients were allocated to ticagrelor 180 mg loading dose followed by 90 mg twice daily plus aspirin, and 4,229 to clopidogrel 300 mg loading dose (with provision for 300 mg clopidogrel at PCI) followed by 75 mg daily for 6–12 months, plus aspirin.
About Coronary Artery Disease (CAD)
Coronary artery disease, also called coronary heart disease, is most often caused by atherosclerosis, and can lead to acute coronary syndrome (ACS).
BRILINTA (ticagrelor) is an investigational oral antiplatelet treatment for ACS. Ticagrelor is a reversibly binding oral adenosine diphosphate (ADP) receptor antagonist. 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.
BRILINTA is the first in a new chemical class, the CPTPs (cyclo-pentyl-triazolo-pyrimidines) and is chemically distinct from the thienopyridines, such as clopidogrel and prasugrel.
AstraZeneca has proposed the name BRILINTA in the US. If approved by the FDA, it will serve as the trade name for ticagrelor. BRILINTA is a trademark of the AstraZeneca group of companies.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com
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