Document Detail


Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease.
MedLine Citation:
PMID:  21722600     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Frequent dosing and requirements for dose adjustments of erythropoiesis-stimulating agents (ESAs) create significant burdens for healthcare providers and have been associated with hemoglobin (Hb) cycling, hampering maintenance of target Hb levels. We compared the frequency of dose changes in dialysis patients who received methoxy polyethylene glycolepoetin beta; (a continuous erythropoietin receptor activator (C.E.R.A.)) or a shorter-acting ESA.
METHODS: Data were analyzed from three Phase III maintenance trials, using almost identical protocols, in dialysis patients treated with C.E.R.A. every 2 weeks (q2w) or every 4 weeks (q4w) or a comparator ESA (epoetin or darbepoetin alpha; at their previous dose/administration interval). Dosage was adjusted to maintain Hb ± 1 g/dl of baseline and 10 - 13.5 g/dl during titration (28 weeks) and evaluation (8 weeks), and 11 - 13 g/dl during follow-up (16 weeks).
RESULTS: Data were analyzed from 564 patients treated with C.E.R.A. q2w, 410 with C.E.R.A. q4w and 572 with comparator ESA at their usual dosing interval. Significantly fewer dose changes were needed in patients receiving C.E.R.A. q2w (p < 0.05) or C.E.R.A. q4w (p < 0.001) than in patients treated with comparator ESAs.
CONCLUSION: This retrospective analysis suggests that C.E.R.A. q4w maintains Hb levels in dialysis patients and requires fewer dose changes compared with other ESAs.
Authors:
J F E Mann; A de Francisco; G Nassar; B Canaud
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical nephrology     Volume:  76     ISSN:  0301-0430     ISO Abbreviation:  Clin. Nephrol.     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-07-04     Completed Date:  2011-08-18     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  0364441     Medline TA:  Clin Nephrol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  9-15     Citation Subset:  IM    
Affiliation:
KfH Kidney Center, Munich, and Department of Medicine IV, University of Erlangen-Nurnberg, Germany. Johannes.mann@kms.mhn.de
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MeSH Terms
Descriptor/Qualifier:
Anemia / blood,  drug therapy*,  etiology
Chronic Disease
Clinical Trials, Phase III as Topic
Drug Administration Schedule
Erythropoietin / administration & dosage*,  analogs & derivatives
Female
Hemoglobins / analysis
Humans
Kidney Diseases / complications*
Male
Middle Aged
Polyethylene Glycols / administration & dosage*
Recombinant Proteins
Chemical
Reg. No./Substance:
0/Hemoglobins; 0/Polyethylene Glycols; 0/Recombinant Proteins; 0/continuous erythropoietin receptor activator; 11096-26-7/Erythropoietin; 113427-24-0/epoetin alfa; 15UQ94PT4P/darbepoetin alfa

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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