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Incidence, Predictors, and Outcomes of In-Hospital Percutaneous Coronary Intervention Following Coronary Artery Bypass Grafting Cardiorespiratory Fitness and Mortality in Healthy Men and Women Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease Double kissing crush in left main coronary bifurcation lesions: A crushing blow to the rival stenting techniques Contrast-Associated Acute Kidney Injury and Serious Adverse Outcomes Following Angiography Long-term outcomes of rotational atherectomy of underexpanded stents. A single center experience Chronic Kidney Disease and Coronary Artery Disease In-Hospital Costs and Costs of Complications of Chronic Total Occlusion Angioplasty Insights From the OPEN-CTO 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.

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