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Anatomical plaque and vessel characteristics are associated with hemodynamic indices including fractional flow reserve and coronary flow reserve: A prospective exploratory intravascular ultrasound analysis A Novel Circulating MicroRNA for the Detection of Acute Myocarditis Nonculprit Lesion Myocardial Infarction Following Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome Optical coherence tomography findings: insights from the “randomised multicentre trial investigating angiographic outcomes of hybrid sirolimus-eluting stents with biodegradable polymer compared with everolimus-eluting stents with durable polymer in chronic total occlusions” (PRISON IV) trial Spontaneous Coronary Artery Dissection: JACC State-of-the-Art Review Canadian spontaneous coronary artery dissection cohort study: in-hospital and 30-day outcomes How Low to Go With Glucose, Cholesterol, and Blood Pressure in Primary Prevention of CVD Diagnosis and Prognosis of Coronary Artery Disease with SPECT and PET Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients Prognostic Implication of Thermodilution Coronary Flow Reserve in Patients Undergoing Fractional Flow Reserve Measurement
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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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