AstraZeneca has announced results from the positive Phase III THEMIS trial, evaluating Brilinta (ticagrelor) in combination with aspirin to reduce major adverse cardiovascular events in patients with coronary artery disease and type II diabetes with no prior heart attack or stroke.
The trial found that the drug combination cut the relative risk for the composite endpoint of cardiovascular death, heart attack, or stroke by 10% compared with aspirin alone, a statistically significant reduction.
Additionally, in a clinically meaningful and pre-specified sub-analysis of patients who had previously undergone a percutaneous coronary intervention (PCI), a procedure to open a blocked or narrowed coronary artery, a 15% relative risk reduction was observed for Brilinta and aspirin for the composite of cardiovascular death, heart attack, or stroke, compared with aspirin alone.
The trial also, however, found an increased risk of bleeding events observed in both THEMIS and the THEMIS-PCI sub-analysis.
More specifically, it increased TIMI major bleeding and intracranial haemorrhage over aspirin alone, albeit without more fatal bleeding.
Brilinta “reduced the risk of cardiovascular events in patients with coronary artery disease and type II 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," noted Mene Pangalos, executive vice president, BioPharmaceuticals R&D at the firm.
"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 II diabetes who have undergone PCI.”
AstraZeneca says that it will work with regulatory authorities to explore an update to the Brilinta label based on the new results.