AstraZeneca presents strong Phase 3 Brilinta data for reducing CV risk
pharmafile | September 2, 2019 | News story | Research and Development, Sales and Marketing | AstraZeneca, Brilinta, pharma
AstraZeneca has unveiled new positive Phase 3 data on the efficacy of Brilinta (ticagrelor) in combination with aspirin, showing that the therapy reduced the relative risk for the composite of cardiovascular (CV) death, heart attack, or stroke compared to aspirin alone.
In patients with coronary artery disease (CAD) and type 2 diabetes (T2D) with no prior heart attack or stroke, the combo reduced this risk by 10% compared with aspirin alone, a benefit deemed as statistically significant.
Furthermore, the therapy was observed to reduce this risk by 15% in a prespecified sub-analysis of patients who had previously undergone a percutaneous coronary intervention (PCI) compared to aspirin alone.
“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,” explained Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca. “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.”
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, also commented: “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.”
AstraZeneca is now prepared to use these data to pursue a label expansion for Brilinta.
Matt Fellows
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