CBS 2019
CBSMD教育中心
English

科学研究

科研文章

荐读文献

Optimal Fluoroscopic Projections of Coronary Ostia and Bifurcations Defined by Computed Tomographic Coronary Angiography Long-term outcomes after treatment of bare-metal stent restenosis with paclitaxel-coated balloon catheters or everolimus-eluting stents: 3-year follow-up of the TIS clinical study ‘Small bifurcation?’ CT myocardial mass volume measurements change therapeutic strategy in coronary artery disease Prognostic Implications of Plaque Characteristics and Stenosis Severity in Patients With Coronary Artery Disease Optical coherence tomography-guided percutaneous coronary intervention in ST-segmentelevation myocardial infarction: a prospective propensity-matched cohort of the thrombectomy versus percutaneous coronary intervention alone trial Classification and treatment of coronary artery bifurcation lesions: putting the Medina classification to the test T and small protrusion (TAP) vs double kissing crush technique: Insights from in-vitro models Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting) One Versus 2-stent Strategy for the Treatment of Bifurcation Lesions in the Context of a Coronary Chronic Total Occlusion: A Multicenter Registry The Natural History of Nonculprit Lesions in STEMI: An FFR Substudy of the Compare-Acute Trial

Original Research

JOURNAL:ACC Article Link

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.