CardioSource WorldNews October 2015 | Page 10

In the treatment of ACUTE CORONARY SYNDROME IMPROVING CV MORTALITY STARTS HERE BRILINTA CAN HELP Proven to save more lives than clopidogrel by reducing cardiovascular (CV) death at 12 months CV death secondary end point: relative risk reduction (RRR) with BRILINTA 90 mg plus aspirin was 21% (absolute risk reduction [ARR] 1.1%) vs clopidogrel plus aspirin1* AT 12 MONTHS, BRILINTA 90 mg PLUS ASPIRIN SIGNIFICANTLY REDUCED THE PRIMARY COMPOSITE END POINT of CV death, myocardial infarction (MI),† or stroke by 16% RRR (ARR 1.9%) vs clopidogrel plus aspirin. The difference between treatments was driven by CV death and MI with no difference in stroke.1* BLEEDING PLATO-defined Non–CABG-related Major plus Minor Bleeding for BRILINTA 90 mg plus aspirin vs clopidogrel plus aspirin (7.7% vs 6.2%) and non–CABG-related Major Bleeding (3.9% vs 3.3%), respectively. About half of the Non-CABG-related Major bleeding events were in the first 30 days. The PLATelet inhibition and patient Outcomes (PLATO) trial did not show an advantage for BRILINTA 90 mg compared with clopidogrel for CABG-related Bleeding (Total Major 81.3% vs 81.8% and Fatal/Life-threatening 43.8% vs 43.0%, respectively). Rates of Major Fatal/Life-threatening CABG-related Bleeding were similar between BRILINTA 90 mg and clopidogrel when study drug was withheld 1-5 days before CABG surgery. When antiplatelet therapy was stopped 5 days before CABG, Major Bleeding occurred in 75% of patients treated with BRILINTA 90 mg and 79% of patients on clopidogrel.1‡ INDICATIONS 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. IMPORTANT SAFETY INFORMATION FOR BRILINTA (ticagrelor) 60-MG AND 90-MG TABLETS WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS A. BLEEDING RISK •BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding •Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage •Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery •If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS •Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided CONTRAINDICATIONS • BRILINTA is contraindicated in patients with a history of intracranial hemorrhage or active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with hypersensitivity (eg, angioedema) to ticagrelor or any component of the product WARNINGS AND PRECAUTIONS • Dyspnea was reported in about 14% of patients treated with BRILINTA, more frequently than in patients treated with control agents. Dyspnea resulting from BRILINTA is often self-limiting • Discontinuation of BRILINTA will increase the risk of MI, stroke, and death. When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding. If BRILINTA must be temporarily discontinued, restart as soon as possible • Avoid use of BRILINTA in patients with severe hepatic impairment. Severe hepatic impairment is likely to increase serum concentration of ticagrelor and there are no studies of BRILINTA in these patients ADVERSE REACTIONS • The most common adverse reactions associated with the use of BRILINTA included bleeding and dyspnea: In PLATO, for BRILINTA vs clopidogrel, non-CABG PLATO-defined major bleeding (3.9% vs 3.3%) and dyspnea (14% vs 8%); in PEGASUS, BRILINTA vs aspirin alone, TIMI Total Major bleeding (1.7% vs 0.8%) and dyspnea (14% vs 6%)