BRILIQUE (ticagrelor) is the only P2Y12 inhibitor licensed in combination with aspirin to protect patients with prior MI and a high risk* of atherothrombotic events against subsequent CV events in both the acute and long-term treatment settings†1
*High risk is defined as ≥1 additional atherothrombotic risk factor (age ≥65 years, >1 prior MI, multivessel coronary artery disease, diabetes requiring medication, chronic non-end-stage renal dysfunction)1
†BRILIQUE (ticagrelor) 90mg twice daily in combination with acetylsalicylic acid (ASA) is indicated for patients with Acute Coronary Syndromes (ACS) for up to 12 months. BRILIQUE (ticagrelor) 90mg twice daily is not indicated for use in patients beyond 12 months. There are limited data on the efficacy and safety of BRILIQUE (ticagrelor) 60mg beyond 3 years of extended treatment
Brilique Clinical Studies
BRILIQUE (ticagrelor) demonstrated acute and long-term CV protection across two large studies: PLATO and PEGASUS-TIMI 54 respectively.4,15
The PLATO study compared BRILIQUE (ticagrelor) (180-mg loading dose, 90mg twice daily thereafter) and clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter) for the prevention of thrombotic CV events (CV death, MI, or stroke) in 18,624 patients admitted to hospital with an ACS with or without ST-segment elevation. Patients were treated for at least 6 months and up to 12 months.4
BRILIQUE (ticagrelor) – the only oral antiplatelet with evidence demonstrating a statistically and clinically significant reduction in CV mortality at 12 months compared to clopidogrel in patients with ACS.4,16
The PEGASUS-TIMI 54 study compared BRILIQUE (ticagrelor) (90 mg twice daily or 60 mg twice daily) vs. placebo, each given with low-dose aspirin, for the prevention of thrombotic CV events (CV death, MI, or stroke) in 21,162 patients ≥50 years of age with a history of MI (1 to 3 years prior to randomisation) and at high risk* of another atherothrombotic event.15
*High risk is defined as ≥1 additional atherothrombotic risk factor (age ≥65 years, >1 prior MI, multivessel coronary artery disease, diabetes requiring medication, chronic non-end-stage renal dysfunction)
PEGASUS-TIMI 54 study: Landmark analysis33
Prespecified subgroup analysis of PEGASUS-TIMI 54 investigating the pattern of ischaemic risk and the consistency of the efficacy and safety of BRILIQUE over time.
- Landmark analyses were performed at yearly intervals from randomisation in patients who were alive and event-free at the start of the landmark period
- Additional sensitivity analyses explored efficacy over time in patients stratified based on the time from qualifying MI to randomisation and the timing of discontinuation of P2Y12 inhibitor therapy before randomisation
Prolonged treatment with Brilique (ticagrelor) 60 mg twice daily + ASA vs placebo + ASA provides consistent benefits over 3 yearsa
A landmark analysis of PEGASUS-TIMI 54 evaluated the pattern of ischaemic risk over time33
The efficacy of Brilique (ticagrelor) 60 mg twice daily with low dose ASA (75-100mg daily) was similar over each sequential year of follow-up33
Risk (KM estimate) of CV death, MI, or stroke (primary endpoint) in patients from the PEGASUS-TIMI 54 trial, analysed year by year. Adapted from Bonaca et al 2017
a There are limited data on the efficacy and safety of BRILIQUE 60 mg beyond 3 years of extended treatment.
PEGASUS-TIMI 54 study: Landmark analysis - Safety33
The risk of bleeding with Brilique (ticagrelor) 60 mg twice daily with low dose ASA (75-100mg daily) vs placebo with low dose ASA is constant after the first year
- There was no significant increase in fatal bleeding or ICH vs placebo at any point
TIMI major bleeding in the PEGASUS-TIMI 54 trial analysed year by year. Only patients who were alive and event-free at the start of each time period were included (on-treatment analysis).
Safety analyses by definition are in patients still on study drugs and therefore, select for a cohort who has tolerated therapy. Thus, the trend for a diminished bleeding risk over time likely reflects selection of patients who have maintained therapy without intolerable bleeding.