Successful PEGASUS-TIMI 54 study for Brilinta for prevention of atherothrombotic events - AstraZeneca

AstraZeneca announced full results from the PEGASUS-TIMI 54 study, a large-scale outcomes trial that investigated Brulinta (ticagrelor) tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrolment. Both 90mg and 60mg study doses of ticagrelor with aspirin significantly reduced the primary composite endpoint of cardiovascular (CV) death, myocardial infarction (MI) or stroke compared to placebo.

As expected with an oral antiplatelet and consistent with studies in similar patient populations, TIMI Major Bleeding, the study’s primary safety endpoint, was higher with both doses of ticagrelor plus aspirin compared to placebo plus aspirin. Importantly, the rates of intracranial haemorrhage (bleeding within the skull) and fatal bleeding were low and were similar between study groups and the placebo arm. The data were presented during the opening late-breaking clinical trial session of the American College of Cardiology’s 64th Annual Scientific Session and Expo, and also simultaneously published in the New England Journal of Medicine online.

In this trial, both study doses of ticagrelor significantly reduced the primary endpoint of CV death, MI or stroke compared to placebo. The rates at 3 years were 7.85% in the ticagrelor 90mg arm, 7.77% in the ticagrelor 60mg arm, and 9.04% in the placebo arm (Hazard Ratio (HR) for ticagrelor 90mg vs placebo 0.85, 95% CI 0.75 – 0.96, P=0.0080; HR for ticagrelor 60mg vs placebo 0.84, 95% CI 0.74 – 0.95, P=0.0043).

See; "Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction."- Marc P. Bonaca, M.D., M.P.H.,et.,al. for the PEGASUS-TIMI 54 Steering Committee and Investigators -March 14, 2015DOI: 10.1056/NEJMoa1500857.