AstraZeneca Reports Results For Phase III PLATO Trial

AstraZeneca has announced results from the phase III head to head trial, PLATO, which demonstrate that ticagrelor (BRILINTA) has achieved greater efficacy in the primary endpoint, reduction of cardiovascular events over clopidogrel (Plavix/Iscover) without an increase in major bleeding.

This efficacy endpoint was driven by a statistically significant reduction in both CV death (4.0% vs. 5.1%, p=0.001) and heart attacks (5.8% vs. 6.9%, p=0.005) with no difference in stroke (1.5% vs. 1.3%, p=0.22). Primary results from the PLATO study were presented at the European Society of Cardiology congress and simultaneously published in the New England Journal of Medicine (NEJM).

The PLATO study confirmed the clinical safety profile of previous ticagrelor studies which showed no difference in major bleeding compared to clopidogrel. When PLATO minor bleeding was added to the major bleeding results, ticagrelor showed an increase versus clopidogrel (16.1% vs. 14.6%, p=0.008). There was also an increase in non-procedural related bleeding with ticagrelor. Within the patient subgroups of gender, weight, history of stroke/TIA, ticagrelor showed no increase in the incidence of major bleeding versus clopidogrel.

Anders Ekblom, executive vice-president of development at AstraZeneca said: “The PLATO study was designed to reflect how patients with ACS are currently managed in clinical practice, by including patients who underwent invasive procedures and those who were managed with medication only. The PLATO data suggest ticagrelor could be a valuable new option for a broad range of acute coronary syndromes patients. We look forward to filing BRILINTA with regulatory authorities in the fourth quarter.”