A safety and efficacy comparison study of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery.
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.
Goldberg
M A
MA
Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.
McCutchen
J W
JW
Jove
M
M
Di Cesare
P
P
Friedman
R J
RJ
Poss
R
R
Guilfoyle
M
M
Frei
D
D
Young
D
D
D000368:Aged; D016063:Blood Loss, Surgical / Q000503:physiopathology*; D001803:Blood Transfusion; D004334:Drug Administration Schedule; D017558:Elective Surgical Procedures; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006452:Hemoglobinometry; D006801:Humans; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D009985:Orthopedics; D011300:Preoperative Care; D011994:Recombinant Proteins
D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa