AstraZeneca has reported positive results from the Phase III Themis clinical trial conducted to assess the combination of Brilinta (ticagrelor) with aspirin in coronary artery disease and type-2 diabetes patients.
Brilinta is an oral, reversible antagonist of the P2Y12 receptor that is designed to inhibit platelet activation.
When combined with aspirin, the drug was found to significantly decrease the risk of major adverse cardiovascular (CV) events in acute coronary syndrome (ACS) patients or those who had a myocardial infarction (MI).
The multi-national, randomised, double‑blind Themis trial was intended to investigate whether the combination could decrease major adverse cardiovascular events (MACE) compared to aspirin alone. MACE is measured as a composite of CV death, MI or stroke.
The study enrolled more than 19,000 patients without any history of heart attack or stroke in 42 countries across North and South America, Asia, Europe and Africa.
According to the study results, Brilinta plus aspirin led to a statistically significant reduction of 10% in the relative risk for MACE versus aspirin alone.
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A sub-analysis of patients who received a previous percutaneous coronary intervention (PCI) showed a 15% decrease in the relative risk when treated with the combination, compared to only aspirin.
The safety of AstraZeneca’s drug was also consistent with its known profile. However, a higher risk of bleeding events was found in the study and also the sub-analysis.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “These positive results show that Brilinta reduced the risk of cardiovascular events in patients with coronary artery disease and type-2 diabetes, and we hope this will make a difference because their risk of heart attack or stroke is almost twice as high as it is among diabetes patients without cardiovascular disease.
“Also, for the first time, these new data identified an easily-recognisable sub-group of stable patients who may benefit most from Brilinta, those with type-2 diabetes who have undergone PCI.”
Currently, Brilinta plus aspirin is indicated to prevent atherothrombotic events in adults with ACS or a history of MI and a high atherothrombotic event risk.
Based on the latest results, AstraZeneca intends to seek approval for expanding Brilinta’s indication.