8/7/2023 0 Comments Pegasus brilintaCentral sleep apnea (CSA) including Cheyne-Stokes respiration (CSR) has been reported in the post-marketing setting in patients taking ticagrelor, including recurrence or worsening of CSA/CSR following rechallenge.Severe hepatic impairment is likely to increase serum concentration of ticagrelor and there are no studies of BRILINTA in these patients Avoid use of BRILINTA in patients with severe hepatic impairment.Clinical trials excluded patients at increased risk of bradyarrhythmias not protected by a pacemaker, and they may be at increased risk of developing bradyarrhythmias Bradyarrhythmias including AV block have been reported in the post-marketing setting. Ticagrelor can cause ventricular pauses.If BRILINTA must be temporarily discontinued, restart as soon as possible When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding. In patients being treated for coronary artery disease, discontinuation of BRILINTA will increase the risk of MI, stroke, and death.Dyspnea from BRILINTA is often self-limiting Dyspnea was reported more frequently with BRILINTA than in patients treated with control agents.BRILINTA is also contraindicated in patients with hypersensitivity (eg, angioedema) to ticagrelor or any component of the product BRILINTA is contraindicated in patients with a history of intracranial hemorrhage or active pathological bleeding such as peptic ulcer or intracranial hemorrhage.Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided.ASPIRIN DOSE AND BRILINTA EFFECTIVENESS IN PATIENTS WITH ACS Stopping BRILINTA increases the risk of subsequent cardiovascular eventsī. If possible, manage bleeding without discontinuing BRILINTA.Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery.Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage.BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding.The primary efficacy endpoint for the study will be time to first occurrence of any cardiovascular event (e.g., death from heart or vascular disease, heart attack, or stroke).IMPORTANT SAFETY INFORMATION FOR BRILINTA ® (ticagrelor) 60-MG AND 90-MG TABLETS WARNINGS: A. In addition to ticagrelor or placebo, patients will take once-daily, concomitant aspirin therapy (75 to 150 mg). Patients will be randomised to either ticagrelor 60 or 90 mg twice daily, or placebo. The study will be event driven and minimum treatment period for a patient is twelve months. This is a randomised, double-blind, three-arm, parallel-group, international, multi-centre study of approximately 21 000 patients in over thirty countries. Such individuals are at substantially increased risk for another cardiovascular event. The study will examine the long-term efficacy and safety of ticagrelor in patients who have sustained a heart attack from one to three years prior to enrolment. This study is being carried out to see if a new drug called ticagrelor on a background of aspirin therapy decreases the frequency of cardiovascular events (e.g., death from heart or vascular disease, heart attack, or stroke). Brief Title: Prevention of cardiovascular events (eg, death from heart or vascular disease, heart attack, or stroke) in patients with prior heart attack using ticagrelor compared to placebo on a background of aspirin.
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