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Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review Outcomes After Orbital Atherectomy of Severely Calcified Left Main Lesions: Analysis of the ORBIT II Study Procedural Success and Outcomes With Increasing Use of Enabling Strategies for Chronic Total Occlusion Intervention Pulmonary hypertension is associated with an increased incidence of NAFLD: A retrospective cohort study of 18,910 patients North American Expert Review of Rotational Atherectomy The Regulation of Pulmonary Vascular Tone by Neuropeptides and the Implications for Pulmonary Hypertension Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis Coronary Calcification and Long-Term Outcomes According to Drug-Eluting Stent Generation Trends in Usage and Clinical Outcomes of Coronary Atherectomy: A Report From the National Cardiovascular Data Registry CathPCI Registry Clinical Characteristics and Long-Term Outcomes of Rotational Atherectomy-J2T Multicenter 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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