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Permanent pacemaker use among patients with heart failure and preserved ejection fraction: Findings from the Acute Decompensated Heart Failure National Registry (ADHERE) National Registry Frailty and Bleeding in Older Adults Undergoing TAVR or SAVR: Insights From the FRAILTY-AVR Study Sleep quality and risk of coronary heart disease-a prospective cohort study from the English longitudinal study of ageing Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial Primary Prevention of Sudden Cardiac Death Coronary plaque redistribution after stent implantation is determined by lipid composition: A NIRS-IVUS analysis Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures Expert Recommendations on Cardiac Computed Tomography for Planning Transcatheter Left Atrial Appendage Occlusion Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers: The ULTIMATE trial Health Status after Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis

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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.