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Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study Outcomes of off- and on-hours admission in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention: A retrospective observational cohort study Complete Versus Culprit-Only Revascularization in STEMI: a Contemporary Review Acute Myocardial Infarction after Laboratory-Confirmed Influenza Infection Inflammation: A New Target For CAD Treatment and Prevention Relation between door-to-balloon times and mortality after primary percutaneous coronary intervention over time: a retrospective study Recurrent Cardiovascular Events in Survivors of Myocardial Infarction with St-Segment Elevation (From the AMI-QUEBEC Study) Effect of Shorter Door-to-Balloon Times Over 20 Years on Outcomes of Patients With Anterior ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention Prognostic significance of QRS fragmentation and correlation with infarct size in patients with anterior ST-segment elevation myocardial infarction treated with percutaneous coronary intervention: Insights from the INFUSE-AMI trial Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3—PRIMULTI): an open-label, randomised controlled trial
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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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