TY - JOUR
T1 - Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta
AU - Halstenson, Charles E.
AU - Macres, Mark
AU - Katz, Stephen A.
AU - Schnieders, James R.
AU - Watanabe, Masakazu
AU - Sobota, Joseph T.
AU - Abraham, Paul A.
PY - 1991/12
Y1 - 1991/12
N2 - Different recombinant human erythropoietin products have been developed. Although they appear to have similar pharmacokinetics and function, these have not been directly compared. This randomized, double‐blind, four‐period crossover study compared the pharmacokinetics and pharmacodynamics of intravenous and subcutaneous epoetin alfa and epoetin beta in 18 normal male volunteers. As a control, three subjects received placebo treatment. After intravenous administration, the steady‐state volume of distribution and β‐phase volume of distribution of epoetin beta were 7.7% and 16.9% larger than for epoetin alfa (p <0.05). The terminal elimination half‐life after intravenous administration of epoetin beta was 20% longer than the terminal elimination half‐life of epoetin alfa. After subcutaneous administration there was a delayed drug absorption with epoetin beta compared with epoetin alfa (p <0.05). There was a small but significantly greater absolute reticulocyte response after subcutaneous epoetin beta compared with subcutaneous epoetin alfa. The findings support differences in the pharmacokinetics and function of epoetin alfa and beta that are possibly caused by differences in their glycosylation. Clinical Pharmacology and Therapeutics (1991) 50, 702–712; doi:
AB - Different recombinant human erythropoietin products have been developed. Although they appear to have similar pharmacokinetics and function, these have not been directly compared. This randomized, double‐blind, four‐period crossover study compared the pharmacokinetics and pharmacodynamics of intravenous and subcutaneous epoetin alfa and epoetin beta in 18 normal male volunteers. As a control, three subjects received placebo treatment. After intravenous administration, the steady‐state volume of distribution and β‐phase volume of distribution of epoetin beta were 7.7% and 16.9% larger than for epoetin alfa (p <0.05). The terminal elimination half‐life after intravenous administration of epoetin beta was 20% longer than the terminal elimination half‐life of epoetin alfa. After subcutaneous administration there was a delayed drug absorption with epoetin beta compared with epoetin alfa (p <0.05). There was a small but significantly greater absolute reticulocyte response after subcutaneous epoetin beta compared with subcutaneous epoetin alfa. The findings support differences in the pharmacokinetics and function of epoetin alfa and beta that are possibly caused by differences in their glycosylation. Clinical Pharmacology and Therapeutics (1991) 50, 702–712; doi:
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U2 - 10.1038/clpt.1991.210
DO - 10.1038/clpt.1991.210
M3 - Article
C2 - 1752115
AN - SCOPUS:0026355305
VL - 50
SP - 702
EP - 712
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
SN - 0009-9236
IS - 6
ER -