CBS 2019
CBSMD教育中心
English

科学研究

科研文章

荐读文献

2-Year Outcomes After Stenting of Lipid-Rich and Nonrich Coronary Plaques A VOYAGER Meta-Analysis of the Impact of Statin Therapy on Low-Density Lipoprotein Cholesterol and Triglyceride Levels in Patients With Hypertriglyceridemia Single-Molecule hsTnI and Short-Term Risk in Stable Patients With Chest Pain Qualitative Methodology in Cardiovascular Outcomes Research: A Contemporary Look Cardiac Troponin Elevation in Patients Without a Specific Diagnosis A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions Predicting Major Adverse Events in Patients With Acute Myocardial Infarction Optimal Stenting Technique for Complex Coronary Lesions Intracoronary Imaging-Guided Pre-Dilation, Stent Sizing, and Post-Dilation Cardiac monocytes and macrophages after myocardial infarction Successful catheter ablation of electrical storm after myocardial infarction

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.