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Pulmonary vascular lesions occurring in patients with chronic major vessel thromboembolic pulmonary hypertension Survival prospects of treatment naïve patients with Eisenmenger: a systematic review of the literature and report of own experience OCT guidance during stent implantation in primary PCI: A randomized multicenter study with nine months of optical coherence tomography follow-up Parallel Murine and Human Plaque Proteomics Reveals Pathways of Plaque Rupture Flow-Regulated Endothelial S1P Receptor-1 Signaling Sustains Vascular Development Cardiovascular risk prediction in type 2 diabetes: a comparison of 22 risk scores in primary care settings Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease Feasibility and efficacy of the ultrashort side branch dedicated balloon in coronary bifurcation stenting Superficial Calcium Fracture After PCI as Assessed by OCT Restricted access Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL 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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