AstraZeneca reported positive phase 3 trial results of Brilinta (ticagrelor) plus aspirin, which reduced the relative risk of cardiovascular events by 10% compared with aspirin alone.
Dubbed the THEMIS trial, Brilinta plus aspirin reduced the relative risk for the composite of cardiovascular death, heart attack, or stroke by 10% (7.7% vs 8.5%) compared with aspirin alone, a statistically significant reduction.
The trial population was patients with coronary artery disease (CAD) and Type 2 diabetes with no prior heart attack or stroke.
In addition, in a 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% (7.3% vs 8.6%) relative risk reduction was observed for Brilinta plus aspirin for the composite of CV death, 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 observed in both THEMIS and the THEMIS-PCI sub-analysis.
“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,” said Mene Pangalos, executive vice president, biopharmaceuticals R&D in a statement.
“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,” Pangalos added.
Dr. Deepak L. Bhatt, THEMIS Co-Chair and Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, and Professor of Medicine at Harvard Medical School, Boston, added that so far, treatment options have been limited for patients with coronary artery disease and Type 2 diabetes.
“The results from THEMIS greatly advance our understanding of cardiovascular risk reduction and refine our understanding of the role of dual antiplatelet therapy in patients across the cardiovascular spectrum,” he said in a press release.
AstraZeneca will work with regulatory authorities to explore an update to the Brilinta label based on these results.
Results from the trials were presented at ESC Congress 2019 in Paris, France.
The results for the overall THEMIS trial were published simultaneously in the New England Journal of Medicine and results from THEMIS-PCI were published in The Lancet.
Brilinta is not approved for use in patients with CAD and T2D who have not yet had a heart attack or stroke. For more information, view the complete press release here.
- AstraZeneca. (2019, September 1). BRILINTA Reduced the Risk of Cardiovascular Events in Patients With Coronary Artery Disease and Type 2 Diabetes in Phase III THEMIS Trial. Business Wire. Retrieved September 3, 2019 from https://www.businesswire.com/news/home/20190901005029/en