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Abstract

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Level of Scientific Evidence Underlying the Current American College of Cardiology/American Heart Association Clinical Practice Guidelines Intravascular ultrasound-guided drug-eluting stent implantation is associated with improved clinical outcomes in patients with unstable angina and complex coronary artery true bifurcation lesions Two-Year Outcomes and Predictors of Target Lesion Revascularization for Non-Left Main Coronary Bifurcation Lesions Following Two-Stent Strategy With 2nd-Generation Drug-Eluting Stents Impact of Artificial Intelligence on Interventional Cardiology: From Decision-Making Aid to Advanced Interventional Procedure Assistance Rotational atherectomy and new-generation drug-eluting stent implantation Nonproportional Hazards for Time-to-Event Outcomes in Clinical Trials: JACC Review Topic of the Week Ticagrelor with or without Aspirin in High-Risk Patients after PCI Vascular response and healing profile of everolimus-eluting bioresorbable vascular scaffolds for percutaneous treatment of chronic total coronary occlusions: A one-year optical coherence tomography analysis from the GHOST-CTO registry
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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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