The Phase III THEMIS trial of UK-based Astra Zeneca's Brilinta (ticagrelor) has met its primary endpoint and demonstrated that Brilinta, taken in conjunction with aspirin, demonstrated a statistically-significant decrease in a composite of major adverse cardiovascular events compared to aspirin alone, it was reported yesterday.
THEMIS was conducted in more than 19,000 patients with coronary artery disease and type- two diabetes with no prior heart attack (myocardial infarction, MI) or stroke. Preliminary safety results were consistent with the known profile of Brilinta. A complete assessment of the THEMIS data will be presented at a forthcoming medical meeting.
Elisabeth Bjork, 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.'
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