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Ticagrelor met primary endpoint in PEGASUS-TIMI 54 trial
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AstraZeneca announced that the PEGASUS-TIMI 54 trial of ticagrelor plus low-dose aspirin for the secondary prevention of atherothrombotic events met its primary efficacy endpoint.
More than 21,000 patients aged 50 years or older who had an MI 1 year to 3 years prior to baseline and at least one additional CV risk factor were enrolled in the randomized, double blind, placebo-controlled trial, which assessed ticagrelor (Brilinta) 60 mg or 90 mg twice daily in addition to low-dose aspirin for secondary prevention of atherothrombotic events, according to a press release. The primary efficacy endpoint was a composite of CV death, MI and stroke.
According to the release, results from a preliminary analysis indicated no unexpected safety issues, and a full evaluation of the data is ongoing.
Ticagrelor is not currently approved for secondary prevention of atherothrombotic events in patients with a history of MI beyond 1 year. It is indicated to reduce the rate of thrombotic CV events in patients with ACS.
Complete results from PEGASUS-TIMI 54, which was conducted at 848 sites in 31 countries, will be submitted for presentation at a scientific meeting in 2015, according to the release.
PEGASUS-TIMI 54 is part of the PARTHENON study program, which also includes the PLATO trial — the basis for the approval of ticagrelor in more than 100 countries — as well as studies investigating the drug for prevention of CV events among patients with peripheral arterial disease, ischemic stroke or transient ischemic attack and diabetes and coronary atherosclerosis, according to the release.
“We are very pleased with the topline results of the PEGASUS-TIMI 54 study, the second positive major outcomes study in the PARTHENON program,” Elisabeth Björk, MD, PhD, vice president and head of cardiovascular and metabolic diseases, global medicines development, for AstraZeneca, said in the release. “The results build on existing understanding of the benefits of [ticagrelor] for patients with [ACS] and offer important clinical insights into its potential role for the longer term prevention of [CV] events. We look forward to presenting the data later this year.”