AstraZeneca Posts Phase 4 Data For ACS Drug Brilinta
British big pharma AstraZeneca unveiled new data from the Phase IV ATLANTIC study investigating its oral antiplatelet drug Brilinta/Brilique (ticagrelor) in ST-segment elevation myocardial infarction (STEMI) patients.
The international, multi center, Phase IV study ATLANTIC (A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention) investigated whether administration of the drug during pre-hospital setting would result in enhanced coronary reperfusion in STEMI patients intended for primary percutaneous coronary intervention (PCI). The company reported no statistical difference between pre-hospital and in-hospital study arms in the drug’s pre-PCI efficacy. There was also no variance in the safety profile of the drug between the two study arms.
“ATLANTIC has indicated that in STEMI patients undergoing primary PCI, ticagrelor has the flexibility to be used safely in either pre-hospital or in-hospital settings with a potential benefit on the early occurrence of stent thrombosis. These results are in line with the new ESC/EACTS 2014 Guidelines on Myocardial Revascularisation that were also presented at this year’s ESC conference, which give a class I recommendation to start dual antiplatelet therapy in STEMI patients at first medical contact,” said Dr. Gilles Montalescot, lead investigator of the ATLANTIC study.
Marc Ditmarsch, global development lead for Brilinta, said, “The results from the ATLANTIC study allow us to better understand the role of Brilinta in treating STEMI patients. The data indicates that Brilinta has the flexibility to be initiated pre-hospital or in-hospital in STEMI patients with no adverse impact on bleeding.” Ditmarsch added that the results also encourage further evaluation of the drug as a tool to reduce the risk of post-PCI stent thrombosis in Brilinta-treated patients.
The results of the ATLANTIC study were published in the New England Journal of Medicine. The company presented the new data at the European Society of Cardiology congress taking place this month in Barcelona.
Ticagrelor is an oral antiplatelet therapy developed by AstraZeneca for acute coronary syndrome (ACS). The drug has received approval in 100 countries including the U.S. and Canada.