THEMIS Top-Line Results: Ticagrelor Cuts CV Event Risk in Diabetics With Coronary Disease

February 25, 2019

A randomized trial of the antiplatelet ticagrelor (Brilinta/Brilique, AstraZeneca) for primary prevention in type 2 diabetes has "met its primary end point" of major adverse cardiac events (MACE), implying a significant benefit, the sponsoring company announced today.

AstraZeneca released cursory top-line results from the 42-country Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS) study in advance of a planned fuller report at a conference or in a journal.

The trial had enrolled 19,271 patients with diabetes and established coronary artery disease (CAD) but no history of myocardial infarction (MI) or stroke. They had been randomized to receive ticagrelor, a P2Y12 receptor antagonist, at 60 mg twice daily or placebo, in both cases on top of aspirin.

The primary MACE end point consisted of cardiovascular death, MI, or stroke. The presence of CAD in the enrolled population was defined as angiographic occlusive coronary disease or a history of myocardial revascularization.

Ticagrelor is not approved for primary prevention in such high-risk patients, but it is approved for MACE reduction in patients with acute coronary syndromes or a history of MI, observes AstraZeneca in the press release containing the THEMIS top-line results.

Safety outcomes in the preliminary THEMIS analysis "were consistent with the known profile of Brilinta," the company states.

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