AstraZeneca’s drug Brilinta® met primary endpoints in Phase 3 trials, the company reported on Monday.
The trials showed that Brilinta (ticagrelor) tablets, taken in with aspirin, showed a statistically significant reduction in major adverse cardiovascular events (MACE, a composite of cardiovascular death, heart attack and stroke) compared to aspirin alone.
The trial dubbed, THEMIS, (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) was conducted in over 19,000 patients with coronary artery disease (CAD) and Type-2 diabetes with no prior heart attack or stroke.
Preliminary safety results were consistent with the known profile of BRILINTA. A full evaluation of the trial data will be presented at an upcoming medical meeting.
“The THEMIS trial is the largest randomized trial of patients with type-2 diabetes performed to date and was designed to evaluate whether more-intense antiplatelet therapy is a promising approach,” said Dr. Deepak L. Bhatt, THEMIS co-Chair and Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and a Professor at Harvard Medical School.
“The results could help us refine our understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum,” he added.
BRILINTA is not approved for use in patients with CAD and Type 2 diabetes who have not yet had a heart attack or stroke.
BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
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BRILINTA’s Phase III THEMIS Trial Met Primary Endpoint in Patients with Established Coronary Artery Disease and Type-2 Diabetes. (2019, Feb. 25) Businesswire. Retrieved: https://www.businesswire.com/news/home/20190225005273/en