A safety and efficacy comparison study of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery

Am J Orthop (Belle Mead NJ). 1996 Aug;25(8):544-52.

Abstract

Previous studies have demonstrated the efficacy of perioperative Epoetin alfa in decreasing allogeneic transfusion exposure in patients undergoing orthopedic surgery. A randomized, multicenter trial was conducted comparing the safety and efficacy of a weekly Epoetin alfa dosing regimen in patients with hemoglobin levels > or = 10 to < or = 13 g/dL scheduled to undergo major elective orthopedic arthroplasty, with a daily regimen previously shown to be effective. patients on the weekly regimen showed a greater baseline-to-presurgery hemoglobin increase versus the daily regimen group (1.44 +/- 1.029 g/dL versus 0.73 +/- 0.867 g/dL). Moreover, the weekly 600 IU/kg regimen was similar to the daily 300 IU/kg regimen with respect to safety and the avoidance of allogeneic transfusion. These data showed the weekly Epoetin alfa regimen to be at least as efficacious as the daily regimen and more convenient.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Blood Loss, Surgical / physiopathology*
  • Blood Transfusion*
  • Drug Administration Schedule
  • Elective Surgical Procedures
  • Epoetin Alfa
  • Erythropoietin / administration & dosage*
  • Erythropoietin / adverse effects
  • Female
  • Hematinics / administration & dosage*
  • Hematinics / adverse effects
  • Hemoglobinometry
  • Humans
  • Intraoperative Period
  • Male
  • Middle Aged
  • Orthopedics*
  • Preoperative Care
  • Recombinant Proteins

Substances

  • Hematinics
  • Recombinant Proteins
  • Erythropoietin
  • Epoetin Alfa