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Ticagrelor (Brilinta) Meets Pivotal Trial’s Primary Endpoint at 60-mg and 90-mg Doses

Treatment reduces thrombotic events in patients with heart attack history

The PEGASUS-TIMI 54 study, a large-scale outcomes trial involving more than 21,000 patients, has successfully met its primary efficacy endpoint.

The study assessed ticagrelor (Brilinta, AstraZeneca) tablets administered at a dosage of either 60 mg twice daily or 90 mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack 1 to 3 years before the start of the study. The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke.

The study investigated the two doses of ticagrelor on a background of low-dose aspirin compared with placebo plus low-dose aspirin in patients 50 years of age and older with a history of heart attack and one additional CV risk factor. The trial was designed to better understand the management of patients more than 12 months after their heart attack, who remain at high risk for major thrombotic events.

Ticagrelor is not approved for the secondary prevention of atherothrombotic events in patients with a history of heart attack beyond 1 year.

The PEGASUS-TIMI 54 (PrEvention With TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients With Prior AcUte Coronary Syndrome –– Thrombolysis in Myocardial Infarction 54) trial involved more than 21,000 patients in Europe, the Americas, Africa, and Australia/Asia. It was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group at Brigham and Women’s Hospital in Boston, Massachusetts.

Ticagrelor is a direct-acting P2Y12 receptor antagonist in the cyclo-pentyl-triazolo-pyrimidine (CPTP) chemical class. The drug works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with acute coronary syndrome (ACS).

Brilinta (ticagrelor) 90 mg is indicated to reduce the rate of thrombotic CV events in patients with ACS (i.e., unstable angina, non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). Ticagrelor has been shown to reduce the rate of a combined endpoint of CV death, MI, or stroke compared with clopidogrel. The difference between treatments was driven by CV death and MI, with no difference in stroke. Ticagrelor also reduces the rate of stent thrombosis in patients treated with percutaneous coronary intervention.

Source: AstraZeneca; January 14, 2015.

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