BRILINTA’s Phase III THEMIS Trial Met Primary Endpoint in Patients with Established Coronary Artery Disease and Type-2 Diabetes
WILMINGTON, Del.--(BUSINESS WIRE)--Feb 25, 2019--The Phase III THEMIS trial met its primary endpoint which demonstrated that BRILINTA ® (ticagrelor) tablets, taken in conjunction 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.
THEMIS was conducted in over 19,000 patients with coronary artery disease (CAD) and type-2 diabetes (T2D) with no prior heart attack or stroke. Preliminary safety results were consistent with the known profile of BRILINTA . A full evaluation of the THEMIS data will be presented at a forthcoming medical meeting.
Elisabeth Björk, Senior Vice President, Head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, said: “Approaches to help reduce cardiovascular morbidity further in patients with coronary artery disease and type-2 diabetes are urgently needed. The positive result from the THEMIS trial may offer a potential benefit for this high-risk patient population.”
Deepak L. Bhatt, MD, MPH, THEMIS co-Chair and Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and a Professor at Harvard Medical School said: “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. The results could help us refine our understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum.”
Gabriel Steg, MD, THEMIS co-Chair and Professor at Université Paris-Diderot, Paris and Professor at the National Heart and Lung Institute, Imperial College, London said: “Patients who have both stable coronary artery disease and diabetes are a sizeable group which remains 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.”
BRILINTA is not approved for use in patients with CAD and T2D 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.
IMPORTANT SAFETY INFORMATION FOR BRILINTA ® (ticagrelor) 60-MG AND 90-MG TABLETS WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
A. BLEEDING RISK
B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
WARNINGS AND PRECAUTIONS
About THEMIS THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) is an AstraZeneca-sponsored, multi-national, randomized, double-blinded trial in patients with CAD and T2D with no prior MI or stroke. THEMIS was designed to test the hypothesis that BRILINTA plus aspirin would reduce major adverse cardiovascular events (MACE), a composite of CV death, MI or stroke, in patients with CAD and T2D with no prior MI or stroke, vs. aspirin alone. CAD was defined as a prior percutaneous coronary intervention (PCI), coronary artery bypass grafting or at least a 50% narrowing of a coronary artery.
The trial was initiated in early 2014, duration was event-driven across 42 countries and more than 19,000 randomized patients were recruited in order to collect 1,385 independently-adjudicated primary endpoint events.
About BRILINTA BRILINTA (ticagrelor) is an oral, reversibly binding, direct-acting P2Y 12 receptor antagonist that works by inhibiting platelet activation. BRILINTA, together with aspirin, has been shown to significantly reduce the risk of major adverse cardiovascular events (MI, stroke or CV death), in patients with acute coronary syndrome (ACS) or a history of MI.
About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
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PUB: 02/25/2019 07:00 AM/DISC: 02/25/2019 07:01 AM