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Abstract

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Impact of coronary anatomy and stenting technique on long-term outcome after drug-eluting stent implantation for unprotected left main coronary artery disease Serial intravascular ultrasound analysis of the main and side branches in bifurcation lesions treated with the T-stenting technique Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry EXCELling in Left Main Intervention Active SB-P Versus Conventional Approach to the Protection of High-Risk Side Branches: The CIT-RESOLVE Trial Apolipoprotein A-V is a potential target for treating coronary artery disease: evidence from genetic and metabolomic analyses Infective endocarditis after transcatheter aortic valve implantation: a nationwide study Leaflet immobility and thrombosis in transcatheter aortic valve replacement
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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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