AstraZeneca's Brilinta reaches primary endpoint in phase 3 trial
AstraZeneca announced on Monday that its phase 3 ‘THEMIS’ trial has met its primary endpoint, and demonstrated that ‘Brilinta’ (ticagrelor) - when taken in conjunction with aspirin - showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone.
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The FTSE 100 pharmaceuticals giant said THEMIS was conducted in more than 19,000 patients with coronary artery disease and type-2 diabetes, with no prior heart attack or stroke.
Preliminary safety results were said to have been consistent with the known profile of Brilinta.
AstraZeneca said a full evaluation of the THEMIS data would be presented at a forthcoming medical meeting.
“Approaches to help reduce cardiovascular morbidity further in patients with coronary artery disease and type-2 diabetes are urgently needed,” said Elisabeth Björk, AstraZeneca senior vice president and head of late cardiovascular, renal and metabolism research and development for biopharmaceuticals.
“The positive result from the THEMIS trial may offer a potential benefit for this high-risk patient population.”
Deepak Bhatt, THEMIS co-chair and executive director of interventional cardiovascular programmes at Brigham and Women's Hospital, and a professor at Harvard Medical School, explained that the THEMIS trial was the largest randomised trial of patients with type-2 diabetes performed to date, and was designed to evaluate whether more-intense antiplatelet therapy was a promising approach.
“The results could help us refine our understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum.”
Gabriel Steg, THEMIS co-chair and a professor at Université Paris-Diderot, Paris and professor at the National Heart and Lung Institute, Imperial College, London added that patients who had both stable coronary artery disease and diabetes were a “sizeable group”, which remained at particularly high risk of major adverse cardiac events.
“The optimal long-term antiplatelet therapy in that group is not fully established.
“We look forward to presenting the full results from the THEMIS trial later this year.”