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Contrast-Associated Acute Kidney Injury and Serious Adverse Outcomes Following Angiography Impact of different final optimization techniques on long-term clinical outcomes of left main cross-over stenting Glucose-lowering Drugs or Strategies, Atherosclerotic Cardiovascular Events, and Heart Failure in People With or at Risk of Type 2 Diabetes: An Updated Systematic Review and Meta-Analysis of Randomised Cardiovascular Outcome Trials PCI and CABG for Treating Stable Coronary Artery Disease Classification of Deaths in Cardiovascular Outcomes Trials Known Unknowns and Unknown Unknowns Mortality Differences Associated With Treatment Responses in CANTOS and FOURIER: Insights and Implications Chronic Kidney Disease and Coronary Artery Disease Catheterization Laboratory Considerations During the Coronavirus (COVID-19) Pandemic: From the ACC’s Interventional Council and SCAI Comparative Accuracy of Focused Cardiac Ultrasonography and Clinical Examination for Left Ventricular Dysfunction and Valvular Heart Disease: A Systematic Review and Meta-analysis Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes
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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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