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AstraZeneca Presents Results Of Two Phase II Trials For Brilinta

Achieved antiplatelet effect and inhibition of platelet aggregation

AstraZeneca has reported the results of the phase II studies, onset/offset and respond for Ticagrelor (Brilinta) at the annual American Heart Association (AHA) scientific sessions in Orlando, FL.

The onset/offset data showed that treatment with Ticagrelor (Brilinta) achieved a rapid onset of antiplatelet effect and inhibition of platelet aggregation (IPA) that was sustained during maintenance phase of treatment and faster offset IPA compared to Clopidogrel, in patients with stable coronary artery disease (CAD) on aspirin therapy.

Inhibition of platelet aggregation (IPA) reduces the risk of clot formation and subsequent thrombotic events. These results were achieved using Ticagrelor 180mg loading dose followed by 90mg twice daily, as studied in Plato (A Study of Platelet Inhibition and Patient Outcomes), compared to clopidogrel 600mg loading dose followed by 75mg once daily dose.

In the Phase II respond study, the antiplatelet effect of Ticagrelor on both Clopidogrel responders and non-responders were evaluated in 98 patients with stable coronary artery disease.

Among patients identified as Clopidogrel responders, switching from Clopidogrel to Ticagrelor resulted in a mean IPA increase of 26% and switching from Ticagrelor to Clopidogrel resulted in a mean IPA decrease of 24%, suggesting that patients can be switched from Clopidogrel to Ticagrelor without interruption of antiplatelet effect.

Among patients identified as Clopidogrel non-responders, the primary endpoint was not upto the mark. This result derives from the higher than expected response to Clopidogrel after 14 days of treatment in patients initially defined as Clopidogrel non-responders.

Additional ad-hoc analysis showed that at steady state (day 14), the IPA response to Ticagrelor was consistently higher compared with Clopidogrel at all post dose assessments. The findings from respond study demonstrated that due to the variability of Clopidogrel response, identification of Clopidogrel non-responders is difficult.