Phase 3 study of Brilinta in acute coronary syndromes

AstraZeneca announced results from the Phase 3 head-to-head trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which compared Brilinta (ticagrelor) plus aspirin to Plavix (clopidogrel bisulfate, from Bristol-Myers Squibb and Sanofi Pharmaceuticals) plus aspirin in the reduction in risk of cardiovascular events in patients with acute coronary syndromes (ACS). PLATO, a patient outcomes study that enrolled 18,624 patients, showed that Brilinta achieved greater efficacy in the primary endpoint, reduction of cardiovascular events (ie, CV death, MI, stroke), over clopidogrel (9.8% versus 11.7%, respectively, at 12 months; p<0.001). The data demonstrated a statistically significant reduction in both CV death (4.0% versus 5.1%, p=0.001) and MI (5.8% versus 6.9%, p=0.005) in patients treated with Brilinta compared to placebo, with no difference in stroke (1.5% vs. 1.3%, p=0.22). The PLATO study confirmed no difference in major bleeding with Brilinta compared to clopidogrel (11.6% versus 11.2%; p=0.43), but did show an increase in minor bleeding (16.1% versus 14.6%; p=0.001).

Brilinta is an oral antiplatelet agent that reversibly binds to the adenosine diphosphate (ADP) receptor. It selectively inhibits P2Y12, a key target receptor for ADP, to inhibit the action of platelets in the blood, thereby reducing thrombotic events. Brilinta is a cyclo-pentyl-triazol-pyrimidine and is chemically distinct from thienopyridines (eg, clopidogrel, prasugrel).

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