Differences in intravenous and subcutaneous application of recombinant human erythropoietin: a multicenter trial.
The aims of this clinical study were to compare the maintenance doses for intravenous (i.v.) and subcutaneous (SC) administration of recombinant human erythropoietin (rhEPO) and to investigate whether there is any difference in the increase of the packed cellular volume (PCV) per week under i.v. and SC administration of rhEPO from two production sites (Genetics Institute, Cambridge, USA; and Boehringer Mannheim, Penzberg, Germany). A total of 90 patients suffering from end-stage renal disease were included in the study. All patients had already been treated for at least 6 months with chronic hemodialysis. The study was carried out as a randomized, multicenter parallel group comparison study with a 1-week pretreatment phase, a subsequent 8-week double-blind phase, and a final open phase. The final open phase consisted of a correction phase and a maintenance phase. The production site had no influence on the PCV increase per week, and there were no differences with respect to tolerability. The median rhEPO dose required to maintain the target PCV of 30 to 35 vol.% was 33 U/kg body weight three times a week in the i.v. group compared with 22 U/kg in the SC group (i.e., an average of 30% less with SC administration). Development or aggravation of hypertension under rhEPO therapy was observed, especially during the correction phase and more frequently in the SC group than in the i.v. group. During the maintenance phase, there was no essential difference between the two groups.
Schaller
R
R
Klinik für Innere Medizin, Friedrich-Schiller-Universität, Jena, Germany.
Sperschneider
H
H
Thieler
H
H
Dutz
W
W
Hans
S
S
Voigt
D
D
Marx
M
M
Engelmann
J
J
Schöter
K H
KH
Scigalla
P
P
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000740:Anemia / Q000097:blood / Q000209:etiology / Q000628:therapy; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects / Q000096:biosynthesis; D005260:Female; D005858:Germany; D006400:Hematocrit; D006801:Humans; D006973:Hypertension / Q000209:etiology; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000096:biosynthesis; D006435:Renal Dialysis
D011994:Recombinant Proteins; D004921:Erythropoietin