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      Clinical Outcomes Associated with Conversion from Epoetin alfa to Darbepoetin alfa in Hospitalized Hemodialysis Patients

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          Background/Aims: Hemodialysis patients are often hospitalized, during which time they require continuity of care in the inpatient setting. The goal of the present study was to evaluate the clinical outcomes associated with a conversion algorithm from outpatient epoetin alfa to inpatient darbepoetin alfa in hospitalized hemodialysis patients at the St. Elizabeth Health Center. Methods: We conducted a retrospective chart review of hemodialysis patient hospital admissions after a therapeutic interchange from epoetin alfa to darbepoetin alfa was implemented at St. Elizabeth Health Center. Chronic hemodialysis patients admitted from December 2002 to October 2003 were identified as part of a therapeutic interchange cohort receiving inpatient darbepoetin alfa after conversion from outpatient epoetin alfa according to the Aranesp® package insert during their hospitalization. After discharge, these patients were returned to their preadmission outpatient epoetin alfa dosages and frequencies. Patients admitted prior to implementation of the therapeutic interchange (January 2002 to April 2002) received epoetin alfa during hospitalization and served as a historical control. Hemoglobin values were recorded prior to hospital admission, at the time of discharge, and 30 days after discharge. Results: Mean hemoglobin levels declined from preadmission to discharge, in both the interchange and historical cohorts (6.6 and 2.5%, respectively) and rebounded at 30 days after discharge. Using a linear regression model, the only variables significantly associated with the hemoglobin level at discharge were the hemoglobin level before admission and receipt of a blood transfusion. Conclusion: An algorithm-based conversion from outpatient epoetin alfa to inpatient darbepoetin alfa for hospitalized chronic hemodialysis patients utilizing the dose conversion table specified in the Aranesp® package insert is associated with hemoglobin outcomes similar to inpatient epoetin alfa.

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          Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin.

          Experiments on human erythropoietin (EPO) demonstrated that there is a direct relationship between the sialic acid-containing carbohydrate content of EPO, its circulating half-life, and in vivo bioactivity. This led to the hypothesis that an EPO analogue engineered to contain additional oligosaccharide chains would have enhanced biological activity. Darbepoetin alfa, a hyperglycosylated recombinant human EPO (rHuEPO) analogue with two extra carbohydrate chains, was designed and developed to test this hypothesis. Comparative pharmacokinetic and pharmacodynamic studies and biochemical analyses of darbepoetin alfa and rHuEPO were performed to define the consequences of the increased carbohydrate content. Due to its increased sialic acid-containing carbohydrate content, darbepoetin alfa has a higher molecular weight, a greater negative charge, and a approximately fourfold lower EPO receptor binding activity than rHuEPO. It also has a threefold longer circulating half-life than rHuEPO in rats and dogs. In spite of its lower receptor binding, and perhaps counterintuitively, darbepoetin alfa is significantly more potent in vivo than rHuEPO. Due to the pharmacokinetic differences, the relative potency of the two molecules varies as a function of the dosing frequency. Darbepoetin alfa is 3.6-fold more potent than rHuEPO in increasing the hematocrit of normal mice when each is administered thrice weekly, but when the administration frequency is reduced to once weekly, darbepoetin alfa is approximately 13-fold to 14-fold more potent than rHuEPO. Increasing the sialic acid-containing carbohydrate content beyond the maximum found in EPO leads to a molecule with a longer circulating half-life and thereby an increased in vivo potency that can be administered less frequently.
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            Long-term cardiorespiratory effects of amelioration of renal anaemia by erythropoietin

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              Erythropoietin Requirements Increase following Hospitalization in End-Stage Renal Disease Patients

              The effect of hospitalization on an ESRD patient’s hemoglobin (Hgb) level and erythropoietin (Epo) requirement has not been investigated. We postulated patients with end stage renal disease required an increased Epo dose to maintain stable Hgb during hospitalization and for a period following discharge. To evaluate this hypothesis, we conducted a retrospective chart review on 65 hemodialysis patients. All hemodialysis patients admitted for more than 2 days who did not have more than the index hospitalizations for 2 months prior to and following discharge were included. Multiple parameters including Hgb, Epo dose, intravenous iron dose, serum iron, TIBC, and ferritin during the 2 months before and the two months after hospitalization, Hgb at admission and discharge, Hgb trough, surgery, blood transfusions and co-morbid factors were evaluated. Statistical significance was evaluated using ANOVA or rank-sum testing, as appropriate. In 65 hemodialysis patients (24 M/41 F, age 58 ± 2.2 years, mean ± SEM), Hgb levels following discharge and for 2 subsequent months were significantly lower than 2 months prior to admission (11.4 ± 0.25 vs. 10.7 ± 0.22 g/dl, p 0.05). There were also no apparent effects of comorbid factors, including surgery, or discharge diagnosis on the changes in Hgb or Epo requirements. However, patients who required a blood transfusion during the hospitalization had lower Hgb levels and higher Epo doses both prior to and after hospitalization, as well as lower Hgb trough levels. In addition, females had lower Hgb levels than males both prior to and after hospitalization, and were receiving a higher Epo dose 191 ± 18 vs. 129 ± 20 U/kg/week at 1 month and 215 ± 18 U/kg/week vs. 134 ± 22, p < 0.005 at 2 months after hospitalization. Conclusion: This study points out that hemodialysis patients experience a significant and prolonged decrease in Hgb levels after hospitalization, even despite a moderate increase in Epo dosing.

                Author and article information

                Am J Nephrol
                American Journal of Nephrology
                S. Karger AG
                January 2007
                19 January 2007
                : 26
                : 6
                : 571-578
                Departments of aInternal Medicine, bPharmacy and cResearch, St. Elizabeth Health Center, dCollege of Health and Human Services, Youngstown State University, Youngstown, Ohio, eDepartment of Internal Medicine, Northeastern Ohio Universities College of Medicine, Rootstown, Ohio, and fAmgen Inc., Thousand Oaks, Calif., USA
                98027 Am J Nephrol 2006;26:571–578
                © 2006 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 3, Tables: 5, References: 21, Pages: 8
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                Original Report: Patient-Oriented, Translational Research


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