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The (R)Evolution of the CICU - Better for the Patient, Better for Education Hospital Readmission After Perioperative Acute Myocardial Infarction Associated With Noncardiac Surgery Canadian SCAD Cohort Study: Shedding Light on SCAD From a United Front Selection of stenting approach for coronary bifurcation lesions Decreased inspired oxygen stimulates de novo formation of coronary collaterals in adult heart Update in the Percutaneous Management of Coronary Chronic Total Occlusions Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents Association of the PHACTR1/EDN1 Genetic Locus With Spontaneous Coronary Artery Dissection BMI, Infarct Size, and Clinical Outcomes Following Primary PCI Patient-Level Analysis From 6 Randomized Trials Reappraisal of Reported Genes for Sudden Arrhythmic Death: An Evidence-Based Evaluation of Gene Validity for Brugada Syndrome
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FDA Updates Prescribing Information For Alirocumab

ACC News Story


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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