Safety and efficacy of low-dose subcutaneous erythropoietin in hemodialysis patients

• Published in: Journal of the American Society of Nephrology Vol. 8; no. 2; pp. 288 - 293
• Main Authors: PARKER, K. P, MITCH, W. E, STIVELMAN, J. C, MACON, E. J, BAILEY, J. L, SANDS, J. M
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01.02.1997
• Subjects: Anemia - blood; Anemia - drug therapy; Anemia - etiology; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Dose-Response Relationship, Drug; Drug Administration Schedule; Emergency and intensive care: renal failure. Dialysis management; Erythropoietin - administration & dosage; Erythropoietin - adverse effects; Female; Ferritins - blood; Hematocrit; Humans; Injections, Intravenous; Injections, Subcutaneous; Intensive care medicine; Male; Medical sciences; Middle Aged; Recombinant Proteins; Renal Dialysis - adverse effects; Reticulocyte Count; Safety; Time Factors; Transferrin - metabolism; Human; Extrarenal dialysis; Erythropoietin; Anemia; Hemodialysis; Treatment efficiency; Clinical trial; Subcutaneous administration; Hemopathy; Cost benefit ratio
• ISSN: 1046-6673; 1533-3450
• DOI: 10.1681/asn.v82288

Anemia in hemodialysis patients is effectively treated by intravenous (IV) injections of recombinant human erythropoietin (rHuEPO) at each dialysis session. Because the hormone is effective by subcutaneous (SC) administration, it was decided that this study would evaluate low-dose weekly SC rHuEPO therapy. To determine the safety and efficacy of weekly SC rHuEPO administration to hemodialysis patients, only one third the weekly IV 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 received weekly SC rHuEPO at one third the weekly IV dose for 10 months; control subjects continued to receive IV therapy. In Phase 3, both groups were treated for 6 more months with IV rHuEPO. In Phase 2, there was no significant reduction in hematocrit value, reticulocyte count, transferrin saturation, or ferritin level in the experimental group, even with only one third the weekly rHuEPO IV dose over the 10-month period. There were no significant differences between IV and SC rHuEPO administration or between experimental and control subjects in blood pressure, 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 hemodialysis patients. This therapy could enhance the efficacy of rHuEPO and substantially reduce costs while preserving patient care outcomes.