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Impact of Optimal Medical Therapy on 10-Year Mortality After Coronary Revascularization Utilization and programming of an automatic MRI recognition feature for cardiac rhythm management devices Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology SGLT2 Inhibitors in Patients With Heart Failure With Reduced Ejection Fraction: A Meta-Analysis of the EMPEROR-Reduced and DAPA-HF Trials Cardiorespiratory Fitness and Mortality in Healthy Men and Women Treating Multivessel Coronary Artery Disease in ST-Segment Elevation Myocardial Infarction: Why, How, and When? Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI Cholesterol-Lowering Agents The Current State of Left Main Percutaneous Coronary Intervention Know Diabetes by Heart: A Partnership to Improve Cardiovascular Outcomes in Type 2 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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