A pharmacodynamic model of erythropoietin therapy for uremic anemia

Clin Pharmacol Ther. 1992 Jan;51(1):76-89. doi: 10.1038/clpt.1992.10.

Abstract

Fifty-seven patients receiving chronic high-flux hemodialysis began receiving recombinant alpha-human erythropoietin (rHuEPO). The mean initial rHuEPO dose used in 54 evaluable patients was 9963 +/- 4364 U/week; the final dose was 8972 +/- 4058 U/week. Treatment over a mean period of 154 +/- 40 days (84 to 224 days) resulted in an average increase in hematocrit from 24.7% +/- 3.7% to 32.5% +/- 4.4%. We present a model for these data that describes changes in hematocrit during rHuEPO therapy and that allows simultaneous estimation of red blood cell lifespan and rHuEPO-induced increases in red blood cell production rate. Analysis of the hematocrit values of the patients with the model, by use of NONMEM, a computer program for analysis of population data, reveals a nonlinear dose-response relationship with large interindividual variability (coefficient of variation) of about 50%. The estimated mean red blood cell lifespan is 64 days, with interindividual variability of about 30% (coefficient of variation). The intraindividual random variability in hematocrit about its prediction is +/- 5% of the prediction. For clinical dose adjustment, we present a method that uses only simple calculations.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Anemia / blood
  • Anemia / drug therapy*
  • Anemia / etiology
  • Dose-Response Relationship, Drug
  • Erythrocyte Aging / drug effects
  • Erythrocytes / drug effects
  • Erythrocytes / physiology
  • Erythropoietin / pharmacokinetics
  • Erythropoietin / therapeutic use*
  • Female
  • Genetic Variation / physiology
  • Hematocrit
  • Humans
  • Male
  • Recombinant Proteins / pharmacokinetics
  • Recombinant Proteins / therapeutic use
  • Software
  • Uremia / blood
  • Uremia / complications
  • Uremia / drug therapy*

Substances

  • Recombinant Proteins
  • Erythropoietin