AstraZeneca reports meeting of primary end point by Brilinta's phase III THEMIS trial.
M2 PHARMA-February 26, 2019-AstraZeneca reports meeting of primary end point by Brilinta's phase III THEMIS trial
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AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Monday that the phase III THEMIS trial met its primary endpoint and demonstrated that Brilinta (ticagrelor), taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE), as compared to aspirin alone.
Reportedly, THEMIS was conducted in over 19,000 patients with coronary artery disease (CAD) and type-2 diabetes (T2D) with no prior heart attack (myocardial infarction, MI) or stroke. Preliminary safety results were consistent with the known profile of Brilinta.
According to the company. a full evaluation of the THEMIS data will be presented at a forthcoming medical meeting. The full results from the THEMIS trial are expected to be presented later this year.
THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) is an AstraZeneca-sponsored, multi-national, randomised, double-blinded trial in patients with CAD and T2D with no prior myocardial infarction 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, myocardial infarction or stroke, in patients with CAD and T2D with no prior myocardial infarction or stroke, vs. aspirin alone. CAD was defined as a prior percutaneous coronary intervention (PCI), bypass surgery or at least a 50% narrowing of a coronary artery.
This trial was initiated in early 2014, duration was event-driven across 42 countries and more than 19,000 patients were randomised in order to collect 1,385 independently-adjudicated primary endpoint events.
AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.
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|Date:||Feb 26, 2019|
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