AstraZeneca announced positive results from the Phase III THEMIS trial which showed Brilinta plus aspirin reduced the relative risk for the composite of cardiovascular death, heart attack, or stroke by 10 percent compared with aspirin alone.
The overall THEMIS trial population was patients with coronary artery disease (CAD) and type-2 diabetes (T2D) with no prior heart attack or stroke.
Additionally, in a sub-analysis of patients who had previously undergone a procedure to open a blocked or narrowed coronary artery, a 15 percent relative risk reduction was observed for Brilinta plus aspirin for the composite of cardiovasculardeath, heart attack, or stroke, compared with aspirin alone.
The safety profile for Brilinta was consistent with the known profile of the medicine with an increased risk of bleeding events.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, 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-recognizable sub-group of stable patients who may benefit most from Brilinta – those with type-2 diabetes who have undergone PCI.”
AstraZeneca will work with regulatory authorities to explore an update to the Brilinta label based on these results, a release stated.
Brilinta works by inhibiting platelet activation. Brilinta, together with aspirin, has been shown to significantly reduce the risk of major adverse cardiovascular events (myocardial infarction, stroke or CV death) in patients with acute coronary syndrome (ACS) or a history of MI.
Brilinta, co-administered with aspirin, is indicated for the prevention of atherothrombotic
Cardiovascular, Renal & Metabolism together form one of AstraZeneca’s three therapy areas and is viewed as a key growth driver for the company, which at last report had 1,500 employees in Delaware.