|NON‒CABG-RELATED BLEEDING RATES||BRILINTA 90 MG + ASPIRIN (n=9235) % (n) PATIENTS WITH EVENT||CLOPIDOGREL + ASPIRIN (n=9186) % (n) PATIENTS WITH EVENT|
|PLATO MAJOR + MINOR||7.7 (713)||6.2 (567)|
|MAJOR||3.9 (362)||3.3 (306)|
|FATAL/LIFE-THREATENING||1.9 (171)||1.6 (151)|
|FATAL||0.2 (15)||0.2 (16)|
|0.3 (26)||0.2 (15)|
|CABG-related bleeding rates||BRILINTA 90 mg + aspirin (n=770) n (%) patients with event||Clopidogrel + aspirin (n=814) n (%) patients with event|
|PLATO total major||626 (81.3)||666 (81.8)|
|Fatal/life-threatening||337 (43.8)||350 (43.0)|
|Fatal||6 (0.8)||7 (0.9)|
|BRILINTA 90 mg + aspirin||Clopidogrel + aspirin||HR||95% CI|
|BRILINTA 90 mg + aspirin||Clopidogrel + aspirin|
*The 12-month bleeding outcome estimate was based on the assumption of similar proportions of event rates for years 1 and 2.
†Adjusted HR: 1.20 (95% CI: 1.04-1.40).
Bleeding was defined by the patient receiving treatment for at least 1 of the following: hemorrhagic stroke, gastrointestinal bleeding, anemia-related bleeding, or other bleeding.4
|BRILINTA 60 mg + aspirin (N=6958)||Placebo + aspirin (N=6996)|
|n (%) PATIENTS WITH EVENT||EVENTS/100 PATIENT-YEARS||n (%) PATIENTS WITH EVENT||EVENTS/100 PATIENT-YEARS|
|TIMI MAJOR‡||115 (1.7)||0.78||54 (0.8)||0.34|
|FATAL§||11 (0.2)||0.08||12 (0.2)||0.08|
|INTRACRANIAL HEMORRHAGE||28 (0.4)||0.19||23 (0.3)||0.14|
|TIMI MAJOR OR MINOR//||168 (2.4)||1.15||72 (1.0)||0.45|
‡TIMI major: fatal bleeding or any intracranial bleeding or clinically overt signs of hemorrhage associated with a drop in Hb of ≥5 g/dL or a fall in Hct of ≥15%.
§Fatal: a bleeding event that directly led to death within 7 days.
//TIMI minor: clinically apparent with 3-5 g/dL decrease in Hb.
BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel.
BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily. Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.