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Systems of Care for ST-Segment–Elevation Myocardial Infarction: A Policy Statement From the American Heart Association 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Mode of Death in Heart Failure With Preserved Ejection Fraction Current Smoking and Prognosis After Acute ST-Segment Elevation Myocardial Infarction: New Pathophysiological Insights Variation in Revascularization Practice and Outcomes in Asymptomatic Stable Ischemic Heart Disease When high‐volume PCI operators in high‐volume hospitals move to lower volume hospitals—Do they still maintain high volume and quality of outcomes? Routine Continuous Electrocardiographic Monitoring Following Percutaneous Coronary Interventions Prevalence of Angina Among Primary Care Patients With Coronary Artery Disease Switching P2Y12-receptor inhibitors in patients with coronary artery disease Generalizing Intensive Blood Pressure Treatment to Adults With Diabetes Mellitus
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FDA Updates Prescribing Information For Alirocumab

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The U.S. Food and Drug Administration (FDA) has updated prescribing information for alirocumab (Praluent) as of April 26, 2019. Specifically, the updated prescribing information states that "Praluent is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated:

  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. (1.1)
  • as adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C. (1.2)"


The FDA update follows data from the ODYSSEY OUTCOMES trial assessing the effect of adding Praluent to maximally-tolerated statins on cardiovascular outcomes in 18,924 patients who had an acute coronary syndrome (ACS) within a year of enrolling in the trial. The original results were published in theNew England Journal of Medicinein November 2018, with a recent subgroup analysis presented at ACC.19. For complete drug label information visit the FDA's DailyMed website.

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