AstraZeneca announced that Brilinta (ticagrelor), an oral antiplatelet agent, has been approved to reduce the rate of thrombotic cardiovascular events in patients with ACS (unstable angina [UA] non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). The FDA approval is based upon data from PLATO (A Study of PLATelet Inhibition and Patient Outcomes), a superiority trial that compared treatment with Brilinta to clopidogrel in 18,624 ACS patients worldwide.
The study demonstrated that treatment with Brilinta led to a greater reduction in the primary end point – a composite of CV death, MI, or stroke – compared to patients who received clopidogrel (9.8% vs. 11.7% at 12 months; 1.9% absolute risk reduction [ARR]; 16% relative risk reduction [RRR]; 95% CI, 0.77, 0.92; P<0.001). The difference in treatments was driven by CV death and MI with no difference in stroke. In PLATO, the absolute difference in treatment benefit versus clopidogrel was seen at 30 days and the Kaplan-Meier survival curves continue to diverge throughout the 12 month treatment period.
The study also demonstrated that treatment with Brilinta for 12 months was associated with a 21% RRR in CV death (4% vs. 5.1%; 1.1% ARR; P=0.001) and a 16% RRR in MI compared to clopidogrel at 12 months (5.8% vs. 6.9%; 1.1% ARR; P<0.005).
Brilinta is a reversibly-binding oral adenosine diphosphate (ADP) receptor antagonist antiplatelet agent. It will be available in a 90mg dosage strength tablet.
For more information call (800) 237-8898 or visit www.astrazeneca-us.com.