AstraZeneca announced results of a sub-analysis of the PEGASUS-TIMI 54 study, which evaluated reasons and rates for discontinuation of Brilinta (ticagrelor) in patients with a history of myocardial infarction (MI), and the efficacy in those patients who stayed on therapy. Findings were presented at the 2015 American Heart Association (AHA) Scientific Sessions in Orlando, Florida.
PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group) evaluated Brilinta 60mg twice daily or 90mg twice daily plus once daily low-dose aspirin compared to placebo plus aspirin, for the long-term prevention of atherothrombotic events in patients ≥50 years old who had a history of MI (1–3 years prior to study initiation) and had one additional risk factor for thrombotic cardiovascular (CV) events. The primary efficacy endpoint was a composite of CV death, MI or stroke at 36 months. In the study, Brilinta 60mg plus aspirin significantly reduced the composite of CV death, MI, or stroke by 16% RRR (ARR 1.27%) vs. placebo plus aspirin (7.8% vs. 9% [HR: 0.84, 95% CI: 0.74–0.95]; P=0.0043) at 3 years. TIMI Major Bleeding rates were 1.7% for Brilinta 60mg plus aspirin vs. 0.8% for placebo plus aspirin. TIMI Major or Minor Bleeding rates were 2.4% vs. 1%, respectively.
Results from the pooled analysis of PEGASUS-TIMI 54 showed that in patients who stayed on therapy, Brilinta reduced the rate of the composite efficacy endpoint of CV death, MI, or stroke at 3 years (HR 0.79, 95% CI: 0.70-0.88), consistent with the results from PEGASUS study. Discontinuing Brilinta due to an Adverse Event (AE) was 8.9% in the placebo arm, 19% and 16.4% in the Brilinta 90mg and 60mg arms, respectively. The most frequent AEs causing discontinuation were bleeding and dyspnea. Rates of AEs leading to discontinuation were highest in the first year at 16% in the 90mg arm, 13% in the 60mg arm, and 6% in the placebo arm. Discontinuation rates over the subsequent 2 years in patients who stayed on therapy were 6.5% in the 90mg arm, 6% in the 60mg arm, and 4.6% in the placebo arm.
The Food and Drug Administration (FDA) recently approved a new 60mg dosage strength for Brilinta to be used in patients with a history of MI beyond the first year. With this expanded indication, Brilinta is now indicated to reduce the rate of CV death, MI, and stroke in patients with acute coronary syndrome (ACS) or a history of MI.
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