PEGASUS-TMI 54 Study: Results Released

Full results from PEGASUS-TMI 54, the large-scale trial investigating AstraZeneca’s Brilinta (ticagrelor) tablets were presented Saturday, March 14 at the American College of Cardiology annual meeting in San Diego, CA.

For patients recovering more than one year from a heart attack, the recommended standard of care has solely been aspirin.

The PEGASUS-TIMI 54 study investigated the effect of combining ticagrelor at 60 mg and 90 mg with low-dose aspirin on reducing the risks of CV death, heart attack, or stroke in patients 50 years and older who had a previous history of heart attack and one additional CV risk factor.

The team noted, both 90 mg and 60 mg doses of ticagrelor combined with aspirin significantly reduced the primary composite endpoint of CV death, MI, and stroke compared to placebo.

Furthermore, the study’s primary safety endpoint was reported higher with both doses of ticagrelor plus aspirin compared to placebo plus aspirin.

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Marc Sabatine, MD, MPH, from Brigham and Women's Hospital in Boston, MA, ommented, “As we would expect, ticagrelor increased the risk of TMI major bleeding, but not fatal bleeding or ICH.”

The researchers found “the efficacy was quite comparable between the doses — the bleeding was less in the 60 mg dose, so preferred would be the lower dosage for the long-term study”.

According to Elisabeth Bjork, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, “As a company we are committed to furthering cardiovascular research and are proud to have delivered the PEGASUS-TIMI 54 study, AstraZeneca’s largest clinical trial, involving more than 21,000 patients worldwide. Building on the landmark PLATO trial in acute coronary syndrome, the positive PEGASUS study adds to the body of evidence for Brilinta and is the first prospective trial to evaluate longer term dual antiplatelet therapy in higher risk patients with a history of a heat attack.”

AstraZeneca had just submitted regulatory filings to the European Medicines Agency and the US food and Drug Administration.