Long-Term Study on Brilinta Safety, Efficacy Announced
AstraZeneca announced results from the PEGASUS-TIMI 54 study that evaluated Brilinta (ticagrelor) tablets with low-dose aspirin vs. placebo for the chronic secondary prevention of atherothrombotic events in patients with a history of heart attack 1–4 years prior to study enrollment. Study findings were presented during the American College of Cardiology's 64th Annual Scientific Session and Expo, and were published in the New England Journal of Medicine.
PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome - Thrombolysis In Myocardial Infarction Study Group) was a large outcomes trial that enrolled over 21,000 patients across over 1,100 sites. Key findings showed that both the 60mg and 90mg study doses of ticagrelor with aspirin significantly reduced the primary composite endpoint of cardiovascular (CV) death, myocardial infarction (MI) or stroke vs. placebo. The rates at three years were 7.77% for ticagrelor 60mg, 7.85% for ticagrelor 90mg, and 9.04% for placebo. The effect on each of the components of the primary endpoint was consistent.
In addition, the primary safety endpoint, TIMI Major Bleeding, was higher with both ticagrelor plus aspirin vs. placebo plus aspirin. The rate at three years were 2.3% for ticagrelor 60mg, 2.6% for ticagrelor 90mg, and 1.06% for placebo. The rates of intracranial hemorrhage and fatal bleeding were low and comparable between the study groups and the placebo group.
Brilinta is a direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. It is currently approved to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina or non-ST-elevation MI or ST-elevation MI).
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