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Prevalence of anginal symptoms and myocardial ischemia and their effect on clinical outcomes in outpatients with stable coronary artery disease: data from the International Observational CLARIFY Registry Epinephrine Versus Norepinephrine for Cardiogenic Shock After Acute Myocardial Infarction Association Between Collateral Circulation and Myocardial Viability Evaluated by Cardiac Magnetic Resonance Imaging in Patients With Coronary Artery Chronic Total Occlusion 4-Step Protocol for Disparities in STEMI Care and Outcomes in Women Cardiopulmonary Exercise Testing: What Is its Value? Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative Heart Regeneration by Endogenous Stem Cells and Cardiomyocyte Proliferation: Controversy, Fallacy, and Progress A Test in Context: E/A and E/e' to Assess Diastolic Dysfunction and LV Filling Pressure Chronic total occlusion intervention of the non-infarct-related artery in acute myocardial infarction patients: the Korean multicenter chronic total occlusion 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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