A 6-MONTH STUDY OF LOW-DOSE RECOMBINANT-HUMAN-ERYTHROPOIETIN ALONE AND IN COMBINATION WITH ANDROGENS FOR THE TREATMENT OF ANEMIA IN CHRONIC-HEMODIALYSIS PATIENTS

Two previous short-term studies (12 weeks and up to 16 weeks) that use d androgens to supplement recombinant human erythropoietin (rHuEPO) fo r the treatment of the anemia associated with end-stage renal disease showed divergent results, Both studies were limited by their brief dur ation, since the hematopoietic effect of androgens does not peak until 5 months. Therefore, we conducted a 6-month, prospective, randomized trial comparing low-dose rHuEPO alone and in combination with androgen s for the treatment of the anemia of end-stage renal failure. Nineteen anemic chronic hemodialysis patients were randomized into two groups, Group A (n = 10) received 1,500 U rHuEPO intravenously three times a week for 26 weeks, Group B (n = 9) received the same dose of rHuEPO pl us nandrolone decanoate 100 mg intramuscularly weekly, Baseline transf errin saturation, serum ferritin, intact serum parathyroid hormone, pl asma aluminum, and hematocrit levels were not significantly different between the groups, At study completion, both groups showed a signific ant increase in mean hematocrit compared with baseline (group A: 24.8% +/- 1.4% to 28.3% +/- 2.8%, P = 0.003; group B: 25.1% +/- 1.5% to 33. 2% +/- 4.5%, P = 0.001), The increase in hematocrit in the rHuEPO plus androgen-treated group was statistically greater than in the rHuEPO-a lone group (8.2% +/- 4.4% v 3.5% +/- 2.8%; P = 0.012). With the except ion of mild discomfort at the injection site, there were no significan t side effects from nandrolone. We conclude that the combination of lo w-dose rHuEPO and nandrolone decanoate is effective treatment for the anemia of end-stage renal failure. (C) 1997 by the National Kidney Fou ndation, Inc.