AstraZeneca announces consistent safety profile for Brilinta

20th March 2019 (Last Updated March 20th, 2019 00:00)

AstraZeneca has reported favourable data from the secondary analysis of Phase III TREAT clinical trial assessing its Brilinta (ticagrelor). It stated that the drug’s safety profile was consistent with the existing data.

AstraZeneca has reported favourable data from the secondary analysis of Phase III TREAT clinical trial assessing its Brilinta (ticagrelor). It stated that the drug’s safety profile was consistent with the existing data.

TREAT evaluated ticagrelor treatment after fibrinolysis, compared to clopidogrel, at 12 months in patients with ST elevation myocardial infarction (STEMI).

The trial was intended to primarily assess non-inferiority in safety of ticagrelor and aspirin combination over clopidogrel plus aspirin at 30 days. It was not statistically driven to identify significance of any treatment effects.

However, a numerical reduction in cardiovascular events was observed with ticagrelor at 12 months.

AstraZeneca Biopharmaceuticals late Cardiovascular, Renal and Metabolism R&D head Elisabeth Björk said: “TREAT is closing the knowledge gap, showing that Brilinta can be used in conjunction with thrombolytic therapy. This is particularly important for those patients who are not able to receive surgical intervention in the immediate hours after a heart attack.”

"TREAT is closing the knowledge gap, showing that Brilinta can be used in conjunction with thrombolytic therapy."

The data from secondary efficacy analysis of TREAT showed similar ischemic risk in the ticagrelor and clopidogrel arms. The risk was measured as a composite of cardiovascular death, MI or stroke after 12 months of therapy.

Secondary safety analysis of the trial revealed consistency with the known profile. Around 1% of patients treated with ticagrelor experienced TIMI major bleeding at 12 months, compared to 1.2% in the case of clopidogrel.

This finding is said to be similar to the prior primary safety outcome report of non-inferiority compared to clopidogrel measured as TIMI major bleeding rates at 30 days.

These results have been presented as a late-breaking abstract at the American College of Cardiology’s 68th Annual Scientific Session in New Orleans, US.

Ticagrelor is an oral, reversible, direct-acting P2Y12 receptor antagonist designed to inhibit platelet activation.

Last month, AstraZeneca reported that Brilinta in combination with aspirin met the Phase III THEMIS trial primary endpoint with a statistically significant reduction in major adverse cardiovascular events.