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†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

 

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)

PRACTICAL study

Study results

Real-world outcomes for BRILIQUE (ticagrelor) 90 mg twice daily in ACS patients support the results of randomised trials

  • In a prospective cohort study in Sweden (n=45,073), outcomes with BRILIQUE vs clopidogrel were comparable with PLATO results25, 26
    • Risk of MI, stroke or all-cause death over 12 months (sensitivity analysis):a 5.6% vs 16.8% (ARR=11.2%, adjusted HR=0.85)
    • Readmissions due to bleeding over 24 months: 5.5% vs 5.2% (adjusted HR=1.20)
  • In PLATO, the risk of MI, stroke or all-cause death over 12 months was 10.2% with BRILIQUE vs 12.3% with clopidogrel (HR=0.84, p<0.001)4
Real world outcomes
Real world outcomes

Unadjusted cumulative incidence of MI, stroke or all-cause death (KM estimate) in real-world patients discharged on DAPT with asprin and either BRILIQUE (ticagrelor) or clopidogrel following an MI. Adapted from Sahlen et al 2016 .

Brilique 90 mg twice daily is licensed for 12 months in ACS patients.1 90.9% of patients prescribed BRILIQUE had an intended treatment duration of ≤12 months, vs 75.5% for clopidogrel.25

Study design25

Prospective cohort study in 45,073 ACS patients enrolled into the Swedish Web system for Enhancement and Development of Evidence-based care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) between 1 January 2010 and 31 December 2013.

Inclusion criteria

  • Cardiac biomarker-verified acute MI (ICD code I21)
  • Age ≥18 years
  • Discharged on DAPT with aspirin (almost exclusively 75 mg daily) and BRILIQUE (n=11,954) or clopidogrel (n=33,119)

Exclusion criteria

  • Previous admission for MI Treatment with oral anticoagulant
  • Revascularisation by CABG during the index hospitalisation

Primary endpoint

  • Time from discharge to the first occurrence of a combination of death, readmission for MI or stroke over 24 months
  • The primary bleeding outcome was time from discharge to hospitalisation with bleeding over 24 months
  • A sensitivity analysis was performed at 12 months

Secondary endpoints

  • Time from discharge to each of the individual components of the primary endpoint
  • The secondary bleeding outcome was the probability of PCI-related in-hospital bleeding, defined as any of the following: puncture site haematoma or pseudoaneurysm, drop in haemoglobin or requirement for prolonged compression, transfusion or surgical intervention

ICD, International Statistical Classification of Diseases and Related Health Problems.