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Comparison of safety and periprocedural complications of transfemoral aortic valve replacement under local anaesthesia: minimalist versus complete Heart Team Minimizing Permanent Pacemaker Following Repositionable Self-Expanding Transcatheter Aortic Valve Replacement Poor Long-Term Survival in Patients With Moderate Aortic Stenosis Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure Heart Failure With Improved Ejection Fraction-Is it Possible to Escape One’s Past? 2019 ACC/AHA/ASE Advanced Training Statement on Echocardiography (Revision of the 2003 ACC/AHA Clinical Competence Statement on Echocardiography): A Report of the ACC Competency Management Committee Transcatheter aortic-valve replacement with a self-expanding prosthesis Is Cardiac Diastolic Dysfunction a Part of Post-Menopausal Syndrome? Clinical Risk Factors and Atherosclerotic Plaque Extent to Define Risk for Major Events in Patients Without Obstructive Coronary Artery Disease: The Long-Term Coronary Computed Tomography Angiography CONFIRM 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.