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Investigating Serious Adverse Drug Reactions in Patients Receiving Erythropoiesis-Stimulating Agents: A Root Cause Analysis Using the "ANTICIPATE" Framework.
Am J Ther
March 2019
The Southern Network on Adverse Reactions (SONAR) Program, University of South Carolina College of Pharmacy, Columbia, SC.
Background: Unexpected serious adverse drug reactions (sADRs) affecting patients with chronic kidney disease (CKD) who received erythropoiesis-stimulating agents were identified by study co-authors. These included pure red cell aplasia (PRCA) after administration of the Eprex formulation of epoetin or the epoetin biosimilar HX575 and fatal anaphylaxis associated with peginesatide, an erythropoietin receptor agonist. We developed and applied a structured framework to describe these sADRs, including root cause analyses and eradication efforts.
View Article and Find Full Text PDFDesign, synthesis, and activity evaluation of novel erythropoietin mimetic peptides.
Bioorg Med Chem Lett
October 2018
Beijing Institute of Pharmacology and Toxicology, State Key Laboratory of Toxicology and Medical Countermeasures, Beijing 100850, China. Electronic address:
The approval of the erythropoietin (EPO) mimetic peptide drug peginesatide in 2012 was a breakthrough for the treatment of secondary anemia. However, due to severe allergic reactions, peginesatide was recalled a year later. In this study, 12 novel peptides were designed and synthesized by substituting specific amino acids of the monomeric peptide in peginesatide, with the aim of obtaining new EPO mimetic peptides with higher activities and lower side effects than the parent compound.
View Article and Find Full Text PDFErythropoietin mimetic peptides and erythropoietin fusion proteins for treating anemia of chronic kidney disease.
Curr Opin Nephrol Hypertens
September 2018
Indiana University Health, Indianapolis, Indiana, USA.
Purpose Of Review: First generation erythropoiesis stimulating agents (ESAs) have short duration of action which requires administration once weekly or greater. Second generation ESAs were developed which have longer duration of action and can be administered one to two times monthly. Erythropoietin (EPO) mimetic peptides (EMPs) activate the EPO receptor but have no structural analogy to EPO, offering the potential for lower cost as they are not biologic drugs.
View Article and Find Full Text PDFPeginesatide for the treatment of anemia due to chronic kidney disease - an unfulfilled promise.
Expert Opin Drug Saf
October 2016
d Department of Renal Medicine , King's College Hospital, London , UK.
Introduction: The introduction of recombinant human erythropoietin revolutionized the management of anemia in patients with chronic kidney disease (CKD). In order to circumvent costly recombinant DNA technology, synthetic chemistry techniques were used to manufacture peginesatide, a synthetic peptide that bore no resemblance to previous erythropoiesis-stimulating agents (ESAs), and yet was capable of stimulating erythropoiesis. Compared with other ESAs, peginesatide was deemed to have advantages related to immunogenicity, administration schedule, and cost.
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