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https://hdl.handle.net/2440/17511
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Type: | Journal article |
Title: | Once-monthly administration of darbepoetin alfa for the treatment of patients with chronic heart failure and anemia - A pharmacokinetic and pharmacodynamic investigation |
Author: | Cleland, J. Sullivan, J. Ball, S. Horowitz, J. Agoram, B. Rosser, D. Yates, W. Tin, L. Fuentealba, P. Burton, P. |
Citation: | Journal of Cardiovascular Pharmacology, 2005; 46(2):155-161 |
Publisher: | Lippincott Williams & Wilkins |
Issue Date: | 2005 |
ISSN: | 0160-2446 1533-4023 |
Statement of Responsibility: | John G. F. Cleland, John T. Sullivan, Stephen Ball, John D. Horowitz, Balaji Agoram, Dylan Rosser, Wayne Yates, Lwin Tin, Paulina Fuentealba, and Paul B. J. Burton |
Abstract: | 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. |
Keywords: | anemia heart failure hemoglobin pharmacokinetics risk factors |
Description: | © 2005 Lippincott Williams & Wilkins, Inc. |
DOI: | 10.1097/01.fjc.0000167013.77092.c4 |
Published version: | http://journals.lww.com/cardiovascularpharm/pages/articleviewer.aspx?year=2005&issue=08000&article=00005&type=abstract |
Appears in Collections: | Aurora harvest 2 Medicine publications |
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