Must erythropoietin be injected by the subcutaneous route for every hemodialyzed patient?

A multicenter, prospective, and controlled trial was performed to evaluate the efficacy and tolerance of intravenous (i.v.) and subcutaneous (s.c.) recombinant erythropoietin (rH-EPO) administration routes in 49 long-term hemodialyzed patients on maintenance phase of treatment, to determine the usefulness of replacing i.v. route by SC route in all of them. Each of these patients had already been treated with rH-EPO by the i.v. route for at least 6 months and included in the protocol on stabilized 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/week) for 29 patients. In each stratum, the further treatment route (i.v. or s.c.) was randomized. Finally, 25 patients continued with i.v. route, and the other 24 changed to the s.c. route. The objective was to maintain a stable hemoglobin level, ranging from 9 to 10 g/dL. Tolerance and consumption in each group (i.v. and s.c.) were compared 4 months later. Globally, for an identical efficacy, rH-EPO needs were lesser using s.c. route (84 U/kg/week) than i.v. 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 the others. With regard to tolerance, only thrombotic events might be less frequent by using s.c. route, but the significance threshold is not reached (P = 0.09). Thus, replacing i.v. route by SC route, especially in high consumers, reduces the cost of treatment by rH-EPO. This benefit might be dependent on previous needs.