etermined that more than 80 percent of patients worldwide, including more than 40 percent of patients in the US, received low maintenance doses of aspirin (100 mg or less). Results for US and non-US patients taking BRILINTA with these low maintenance doses of aspirin were similar. Maintenance doses of aspirin above 100 mg reduced the effectiveness of BRILINTA, and should be avoided. After any initial dose, BRILINTA should be used with maintenance aspirin doses of 75-100 mg per day. As with any unplanned subset analysis, the post hoc analysis should be treated with caution.
IMPORTANT SAFETY INFORMATION ABOUT BRILINTA (ticagrelor) TABLETS
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 planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery.
Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA.
If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events.
ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75-100 mg per day.
Risk factors for bleeding include older age, a history of bleeding disorders, performance of percutaneous invasive procedures and concomitant use of medications that increase the risk of bleeding.
If BRILINTA must be temporarily discontinued, it should be restarted as soon as possible.
The use of BRILINTA is also contraindicated in severe hepatic impairment. BRILINTA has not been studied in patients with moderate hepatic impairment. Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.
Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients treated with clopidogrel. If dyspnea is determined to be related to BRILINTA, no specific treatment is required; continue BRILINTA without interruption.
BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers.
Avoid simvastatin and lovastatin doses greater than 40 mg. BRILINTA will result in higher serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4.
Monitor digoxin levels with initiation of or any change in BRILINTA therapy, because of inhibition of the P-glycoprotein transporter.
There is limited clinical experience in patients at increased risk of symptomatic bradycardic events. In PLATO, syncope, pre-syncope and loss of consciousness were reported by 1.7% and 1.5% of BRILINTA and clopidogrel patients, respectively. In a Holter substudy of about 3,000 patients in PLATO, more patients had ventricular pauses with BRILINTA (6%) than with clopidogrel (3.5%), in the acute phase; rates were 2.2% and 1.6% respectively after one month.
The most commonly observed adverse reactions associated with the use of BRILINTA vs. clopidogrel were bleeding (11.6% vs.11.2%) and dyspnea (14% vs. 8%).
替卡格雷的利与弊
关于替卡格雷（ticagrelor，Brilinta）的研究结果在2009年的欧 |
