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Guidelines in review: Comparison of the 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes and the 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation Better Prognosis After Complete Revascularization Using Contemporary Coronary Stents in Patients With Chronic Kidney Disease Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association Homeostatic Chemokines and Prognosis in Patients With Acute Coronary Syndromes Precisely Tuned Inhibition of HIF Prolyl Hydroxylases Is Key for Cardioprotection After Ischemia A Novel Familial Cardiac Arrhythmia Syndrome with Widespread ST-Segment Depression Utility and Challenges of an Early Invasive Strategy in Patients Resuscitated From Out-of-Hospital Cardiac Arrest Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions Multivessel Versus Culprit-Vessel Percutaneous Coronary Intervention in Cardiogenic Shock Coronary flow velocity reserve predicts adverse prognosis in women with angina and noobstructive coronary artery disease: resultsfrom the iPOWER study

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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.