BRILIQUE® (ticagrelor)
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†6
*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)
†BRILIQUE (ticagrelor) 90mg b.d. in combination with ASA is indicated for patients with Acute Coronary Syndromes (ACS) for up to 12 months. BRILIQUE (ticagrelor) 90mg b.d. 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
Clinical Studies
BRILIQUE demonstrated acute and long-term CV protection across two large studies: PLATO and PEGASUS-TIMI 54.24,3
The PLATO study compared BRILIQUE (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 with ACS (UA, NSTEMI, STEMI). Patients were treated for at least 6 months and up to 12 months.24
BRILIQUE 90mg – the only OAP to significantly reduce CV mortality at 12 months compared with clopidogrel.24,28
The PEGASUS-TIMI 54 study compared BRILIQUE (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.3
*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)
PLATO
Study design
The PLATO study was a large, multicentre, double-blind, randomised trial.24
aSTEMI patients for primary PCI were randomised, however, they may not have received PCI
bA loading dose of 300mg clopidogrel was permitted in patients not previously treated with clopidogrel, with an additional 300mg allowed at the discretion of the investigator
cThe PLATO study expanded the definition of major bleeding to be more inclusive compared with previous studies in ACS patients. The primary safety endpoint was the first occurrence of any major bleeding event
Major fatal or life-threatening bleed: Clinically apparent with >50g/L decrease in haemoglobin or ≥4 red cell units transfused; or fatal; or intracranial; or intrapericardial with cardiac tamponade; or with hypovolaemic shock or severe hypotension requiring pressors or surgery. Major other: Clinically apparent with 30–50g/L decrease in haemoglobin or 2–3 red cell units transfused; or significantly disabling
BRILIQUE 90mg significantly reduced CV events vs. clopidogrel24
More CV events can be avoided using BRILIQUE 90mg instead of clopidogrel in ACS patients.24
More than half of the absolute risk reduction with BRILIQUE 90mg occurred after 30 days treatment, and continued to diverge from that of clopidogrel over 12 months of continuous therapy.24
BRILIQUE 90mg significantly reduced CV mortality vs. clopidogrel24
BRILIQUE 90mg demonstrated a reduction in CV mortality vs. clopidogrel24
PLATO bleeding rates
There was no increase in total major and fatal bleeding despite improved efficacy vs. clopidogrel24
Non-CABG related major bleeding was higher with BRILIQUE 90mg than with clopidogrel (PLATO criteria: 4.5% vs 3.8%, p=0.03)24
Bleeding definitions in the PLATO study
Major fatal/life threatening bleed: Clinically apparent with >50g/L decrease in haemogloblin or ≥4 red cell units transfused; or fatal; or intracranial; or intrapericardial with cardiac tamponade; or with hypovolaemic shock or severe hypotension requiring pressors or surgery.6
Major other: Clinically apparent with 30–50g/L decrease in haemoglobin or 2–3 red cell units transfused; or significantly disabling.6
Major bleed: Requires medical intervention to stop or treat bleeding.6
Minor bleeding: Any bleeding episode requiring medical intervention but not meeting the criteria for major bleeding.11
Minimal bleeding: Bleeding not requiring intervention or treatment.11