SAFETY AND EFFICACY OF LOW-DOSE SUBCUTANEOUS ERYTHROPOIETIN IN HEMODIALYSIS-PATIENTS

Anemia in hemodialysis patients is effectively treated by intravenous (IV) injections of recombinant human erythropoietin (rHuEPO) at each d ialysis session. Because the hormone is effective by subcutaneous (SC) administration, it was decided that this study would evaluate low-dos e weekly SC rHuEPO therapy. To determine the safety and efficacy of we ekly SC rHuEPO administration to hemodialysis patients, only one third the weekly TV dose was given and the effects were compared with those from an age-, gender-, and nephrologic disease-matched control group treated in the standard fashion. Forty-four patients entered the trial and 27 completed the protocol along with 27 control subjects. During Phase 1, experimental and control subjects received standard IV rHuEPO at dialysis for 6 months. During Phase 2, experimental patients recei ved weekly SC rHuEPO at one third the weekly IV dose for 10 months; co ntrol subjects continued to receive IV therapy. In Phase 3, both group s were treated for 6 more months with IV rHuEPO. In Phase 2, there was no significant reduction in hematocrit value, reticulocyte count, tra nsferrin saturation, or ferritin level in the experimental group, even with only one third the weekly rHuEPO IV dose over the 10-month perio d. There were no significant differences between IV and SC rHuEPO admi nistration or between experimental and control subjects in blood press ure, serum chemistries, or parameters of ''dialysis adequacy.'' It was concluded that low-dose weekly SC rHuEPO administration is a safe and effective method for maintaining the hematocrit level of stable hemod ialysis patients. This therapy could enhance the efficacy of rHuEPO an d substantially reduce costs while preserving patient care outcomes.