AstraZeneca Brilinta Phase III trial meets primary goal

WILMINGTON: British drugmaker AstraZeneca Plc recently announced that 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.

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