Brilinta: Additional Phase III data

Additional data from the double-blind, international Phase III PEGASUS-TIMI 54 trial in 21,162 patients ages >=50 who had experienced a heart attack 1-3 years prior to the start of the study and who had 1 additional CV risk factor showed that twice-daily 60 and 90 mg oral Brilinta plus low-dose aspirin reduced the risk of a composite of CV death, non-fatal MI and non-fatal stroke, the primary endpoint, to 7.77% and 7.85%, respectively, at 3 years vs. 9.04% for placebo plus low-dose aspirin (p=0.0043 and p=0.008, respectively). Low-and high-dose Brilinta plus low-dose aspirin each missed the secondary endpoints of reducing the rates of CV death (2.86% and 2.94%, respectively, vs. 3.39%, p=0.07 and p=0.15, respectively) and all-cause mortality (4.69% and 5.15%, respectively, vs. 5.16%, p=0.14 and p=0.99, respectively) vs. placebo plus low-dose aspirin.

Low-and high-dose Brilinta plus low-dose aspirin did lead to significantly higher Thrombolysis in Myocardial Infarction (TIMI) major bleeding rates at 3 years vs. placebo plus low-dose aspirin (2.3% and 2.6%, respectively, vs. 1.06%, p<0.001 for both). Additionally, low- and high-dose Brilinta plus low-dose aspirin led to fatal bleeding rates at 3 years of 0.25% and 0.11%, respectively, vs. 0.26% for placebo plus low-dose aspirin (p=1.0 and p=0.27, respectively) and intracranial hemorrhage rates at 3 years of 0.61% and 0.56%, respectively, vs. 0.47% for placebo plus low-dose aspirin (p=0.31 and p=0.19, respectively). Data were presented at the American College of Cardiology meeting in San Diego and published in The New England Journal of Medicine. ...