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Active factor XI is associated with the risk of cardiovascular events in stable coronary artery disease patients Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis: A pooled analysis of the Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 3 and 4 trials EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion – an update Contemporary prevalence of pulmonary arterial hypertension in adult congenital heart disease following the updated clinical classification New Evidence Supporting a Novel Conceptual Framework for Distinguishing Proportionate and Disproportionate Functional Mitral Regurgitation Long-Term Outcomes of Different Two-Stent Techniques With Second-Generation Drug-Eluting Stents for Unprotected Left Main Bifurcation Disease: Insights From the FAILS-2 Study Left main coronary angioplasty: early and late results of 127 acute and elective procedures Pulmonary vascular lesions occurring in patients with chronic major vessel thromboembolic pulmonary hypertension Rotational Atherectomy in acute STEMI with heavily calcified culprit lesion is a rule breaking solution
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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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