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Heart Failure With Mid-Range (Borderline) Ejection Fraction: Clinical Implications and Future Directions Impact of intravascular ultrasound on the long-term clinical outcomes in the treatment of coronary ostial lesions Sex Differences in Heart Failure With Preserved Ejection Fraction Pathophysiology: A Detailed Invasive Hemodynamic and Echocardiographic Analysis Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions: Endorsed by the Chinese Society of Cardiology Novel predictor of target vessel revascularization after coronary stent implantation: Intraluminal intensity of blood speckle on intravascular ultrasound IVUS in bifurcation stenting: what have we learned? Plasma Ionized Calcium and Risk of Cardiovascular Disease: 106 774 Individuals from the Copenhagen General Population Study Initial Invasive or Conservative Strategy for Stable Coronary Disease Myocardial bridging: contemporary understanding of pathophysiology with implications for diagnostic and therapeutic strategies
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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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