AstraZeneca’s Brilinta (ticagrelor) has been found to reduce cardiovascular events in patients with coronary heart disease and diabetes but no prior heart attack or stroke.
The Phase III THEMIS trial, the largest randomised trial of patients with type II diabetes performed to date, met its primary endpoint and demonstrated that the drug showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone, when taken in conjunction with aspirin.
The study consisted of over 19,000 patients with coronary artery disease (CAD) and type II diabetes with no prior heart attack (myocardial infarction, MI) or stroke. In this instance, CAD was defined as a prior percutaneous coronary intervention (PCI), bypass surgery or at least a 50% narrowing of a coronary artery.
The results are expected to help refine understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum.
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.”
The treatment is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation, which when co-administered with aspirin is indicated for the prevention of atherothrombotic events in adult patients with ACS, or for patients with a history of MI and a high risk of developing an atherothrombotic event.