| Once-weekly compared with three-times-weekly subcutaneous epoetin beta: results from a randomized, multicenter, therapeutic-equivalence study. | |
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MedLine Citation:
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PMID: 12087569 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The ability to reduce the administration frequency of subcutaneous (SC) epoetin could provide benefits. This multicenter open-label study investigated the therapeutic equivalence of SC epoetin beta once-weekly and thrice-weekly administration regimens in maintaining anemia correction in stable hemodialysis (HD) patients. METHODS: One hundred seventy-three patients were randomly assigned to either once-weekly epoetin beta (n = 84) or their original thrice-weekly regimen (n = 89) for 24 weeks. All patients were administered intravenous iron supplementation, as required. RESULTS: The per-protocol analysis included 134 patients (69 patients, once-weekly group; 65 patients, thrice-weekly group). Mean hematocrits in both groups remained stable throughout the study. The difference in mean time-adjusted area under the curve for hematocrits between the once-weekly and thrice-weekly groups (-0.54 vol%) and 90% confidence intervals (-1.27 to 0.19) were within the prespecified equivalence range (-2 to +2 vol%). There was no significant change in epoetin beta dose during the study. The ratio of mean weekly epoetin beta doses in the once-weekly and thrice-weekly groups (1.11) and 90% confidence interval (0.99 to 1.23) also remained within the prespecified range (0.8 to 1.25). Intention-to-treat analysis results were similar to per-protocol analysis results. Both regimens were well tolerated. CONCLUSION: Once-weekly and thrice-weekly SC epoetin beta administrations are statistically equivalent in terms of maintaining both stable hematocrits and epoetin beta dose requirements in HD patients. These findings may improve compliance among patients. |
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Authors:
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Francesco Locatelli; Conrad A Baldamus; Giuseppe Villa; Alexandru Ganea; Angel L Martín de Francisco |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: American journal of kidney diseases : the official journal of the National Kidney Foundation Volume: 40 ISSN: 1523-6838 ISO Abbreviation: Am. J. Kidney Dis. Publication Date: 2002 Jul |
Date Detail:
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Created Date: 2002-06-27 Completed Date: 2002-07-17 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8110075 Medline TA: Am J Kidney Dis Country: United States |
Other Details:
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Languages: eng Pagination: 119-25 Citation Subset: IM |
Copyright Information:
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Copyright 2002 by the National Kidney Foundation, Inc. |
Affiliation:
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Divisione di Nefrologia e Dialisi, Ospedale A. Manzoni, Lecco, Italy. nefrologia@ospedale.lecco.it |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anemia
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drug therapy Drug Administration Schedule Erythropoietin / administration & dosage*, pharmacokinetics*, therapeutic use Erythropoietin, Recombinant* Female Humans Injections, Subcutaneous Male Middle Aged Renal Dialysis / methods Therapeutic Equivalency |
| Chemical | |
Reg. No./Substance:
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0/Erythropoietin, Recombinant; 0/epoetin beta; 11096-26-7/Erythropoietin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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