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Quantitative angiography methods for bifurcation lesions: a consensus statement update from the European Bifurcation Club IVUS Guidance Is Associated With Better Outcome in Patients Undergoing Unprotected Left Main Coronary Artery Stenting Compared With Angiography Guidance Alone Management of Acute Myocardial Infarction During the COVID-19 Pandemic From Nonclinical Research to Clinical Trials and Patient-registries: Challenges and Opportunities in Biomedical Research High-Risk Coronary Atherosclerosis: Is It the Plaque Burden, the Calcium, the Lipid, or Something Else? HFpEF: From Mechanisms to Therapies Prognostic Effect and Longitudinal Hemodynamic Assessment of Borderline Pulmonary Hypertension Current Interventions for the Left Main Bifurcation Comparative analysis of recurrent events after presentation with an index myocardial infarction or ischaemic stroke Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death A Systematic Review and Meta-Analysis
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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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