AstraZeneca has announced detailed results from the positive Phase III THEMIS trial, which showed BRILINTA (ticagrelor) plus aspirin reduced the relative risk for the composite of cardiovascular (CV) death, heart attack, or stroke by 10% (7.7% vs. 8.5%) compared with aspirin alone, a statistically significant reduction.
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 clinically meaningful and prespecified 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.
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-recognisable sub-group of stable patients who may benefit most from BRILINTA—those with type 2 diabetes who have undergone PCI.”
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, USA, said: “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.”
Gabriel Steg, THEMIS co-chair and professor at Université de Paris, said: “Patients with type 2 diabetes who had undergone a percutaneous coronary intervention face a similar risk of a cardiovascular event as those who have had a heart attack. The PCI population is a sizeable and easily identifiable group of patients that we hope in the future will be considered for long-term therapy with BRILINTA and aspirin.”
AstraZeneca will work with regulatory authorities to explore an update to the BRILINTA label based on these results.
Results from THEMIS and THEMIS-PCI were presented on 1 September 2019 at ESC Congress 2019 (the annual meeting of the European Society of Cardiology) 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.