Label expansion for P2Y12 inhibitor to treat CAD patients without history of stroke or MI
The FDA has approved the P2Y12 inhibitor ticagrelor for the treatment of coronary artery disease (CAD) patients without a history of myocardial infarction (MI) or stroke. This approval was based on results from the phase III THEMIS trial. THEMIS showed that therapy of aspirin plus ticagrelor reduced the primary composite endpoint of major adverse CV events (MACE) in patients with CAD and T2DM compared to aspirin alone. These patients had a high risk of MI or stroke.
The THEMIS trial showed a relative risk reduction of the composite endpoint of MI, stroke and CV death by 10% with aspirin plus ticagrelor compared to aspirin alone in patients with CAD and T2DM, but without a history of MI or stroke. Efficacy of ticagrelor was established in a patient population of T2DM patients in the THEMIS trial, but the indication is not limited to this setting. Safety profile was consistent with that observed in previous studies with an increased risk of bleeding.
Regulatory review of submissions to expand the indication for ticagrelor based on data from the THEMIS trial is currently ongoing in the EU, Japan and China.
Ticagrelor is approved for the prevention of atherothrombotic events in adult patient with acute coronary syndrome (ACS) and for the secondary prevention of CV events in high-risk patients who have a history of prior MI.
The THEMIS trial is a multi-national, randomized, double-blinded phase 3 trial in >19,000 patients with CAD and T2DM with no history of MI or stroke. CAD was defined as PCI, bypass surgery or at least a 50% narrowing of a coronary artery. THEMIS-PCI is a prespecified subanalysis of patients who had previously undergone PCI.