Js. Virot et al., MUST ERYTHROPOIETIN BE INJECTED BY THE SUBCUTANEOUS ROUTE FOR EVERY HEMODIALYZED PATIENT, American journal of kidney diseases, 28(3), 1996, pp. 400-408
A multicenter, prospective, and controlled trial was performed to eval
uate the efficacy and tolerance of intravenous (IV) and subcutaneous (
SC) recombinant erythropoietin (rH-EPO) administration routes in 49 lo
ng-term hemodialyzed patients on maintenance phase of treatment, to de
termine the usefulness of replacing IV route by SC route in all of the
m. Each of these patients had already been treated with rH-EPO by the
IV route for at least 6 months and included in the protocol on stabili
zed consumption phase, We arbitrarily chose three strata according to
previous needs: Stratum A (>150 U/kg/week) for eight patients, Stratum
B (100 to 150 U/kg/week) for 12 patients, and Stratum C (<100 U/kg/we
ek) for 29 patients, In each stratum, the further treatment route (IV
or SC) was randomized. Finally, 25 patients continued with IV route, a
nd the other 24 changed to the SC route, The objective was to maintain
a stable hemoglobin level, ranging from 9 to 10 g/dL, Tolerance and c
onsumption in each group (IV and SC) were compared 4 months later, Glo
bally, for an identical efficacy, rH-EPO needs were lesser using SC ro
ute (84 U/kg/week) than IV route (112 U/kg/week) (P = 0.02), However,
when the strata were studied, it transpires that this benefit existed
only for consumers having the highest needs (Stratum A) and not for th
e others, With regard to tolerance, only thrombotic events might be le
ss frequent by using SC route, but the significance threshold is not r
eached (P = 0.09), Thus, replacing IV route by SC route, especially in
high consumers, reduces the cost of treatment by rH-EPO, This benefit
might be dependent on previous needs. (C) 1996 by the National Kidney
Foundation, Inc.