Source:http://linkedlifedata.com/resource/pubmed/id/16044026
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
2
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pubmed:dateCreated |
2005-7-26
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pubmed:abstractText |
In patients with chronic heart failure (CHF), anemia is associated with more severe symptoms and worse prognosis. Erythropoiesis-stimulating proteins (ESPs) increase hemoglobin and may be of therapeutic benefit. We investigated the pharmacokinetics and pharmacodynamics of the long-acting ESP, darbepoetin alfa, administered on 2 occasions 1 month apart to 30 healthy subjects and 33 patients with symptomatic CHF and anemia (hemoglobin<or=12.5 g/dL) in 2 randomized, double-blind, placebo-controlled studies. Subcutaneous (SC) and intravenous administration of 0.75 microg/kg of darbepoetin alfa were compared in a crossover study. The second study compared 2.0, 3.0, and 5.0 microg/kg SC doses with placebo. Darbepoetin alfa (0.75 microg/kg SC) pharmacokinetics were similar in CHF patients and healthy subjects, with a mean (+/-SD) bioavailability of 29 (+/-11)% and 37 (+/-8)%, respectively. In anemic CHF patients, mean (+/-SD) increases in hemoglobin at 4 weeks after the second monthly dose of 2.0, 3.0, and 5.0 microg/kg (SC) of darbepoetin alfa were 2.3 (+/-0.6), 1.4 (+/-1.0), and 2.4 (+/-1.9) g/dL, respectively. Darbepoetin alfa 0.75 microg/kg (SC) given twice, 1 month apart, was insufficient to increase hemoglobin in this study. No severe, drug-related adverse events occurred. Darbepoetin alfa administered once monthly elevates and maintains the hemoglobin concentration in patients with CHF and anemia.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Aug
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pubmed:issn |
0160-2446
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
46
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
155-61
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:16044026-Aged,
pubmed-meshheading:16044026-Anemia,
pubmed-meshheading:16044026-Biological Availability,
pubmed-meshheading:16044026-Cardiac Output, Low,
pubmed-meshheading:16044026-Chronic Disease,
pubmed-meshheading:16044026-Cross-Over Studies,
pubmed-meshheading:16044026-Double-Blind Method,
pubmed-meshheading:16044026-Drug Administration Schedule,
pubmed-meshheading:16044026-Erythropoietin,
pubmed-meshheading:16044026-Female,
pubmed-meshheading:16044026-Hemoglobins,
pubmed-meshheading:16044026-Humans,
pubmed-meshheading:16044026-Injections, Intravenous,
pubmed-meshheading:16044026-Injections, Subcutaneous,
pubmed-meshheading:16044026-Male,
pubmed-meshheading:16044026-Middle Aged
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pubmed:year |
2005
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pubmed:articleTitle |
Once-monthly administration of darbepoetin alfa for the treatment of patients with chronic heart failure and anemia: a pharmacokinetic and pharmacodynamic investigation.
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pubmed:affiliation |
Department of Cardiology, University of Hull, Castle Hill Hospital, Kingston upon Hull, UK. j.g.cleland@hull.ac.uk
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase I
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