EFFECTIVENESS AND SAFETY OF RECOMBINANT-HUMAN-ERYTHROPOIETIN (RHUEPO)IN THE TREATMENT OF ANEMIA OF CHRONIC-RENAL-FAILURE IN NON DIALYSIS PATIENTS

Seventy-five non-dialized patients with chronic renal failure (CRF) an d severe renal anemia were enrolled in a study, receiving r-HuEPO subc utaneously thrice weekly for 6 months. In 64 patients (85%) 7 weeks of treatment with a weekly dose of 158 U/kg were required to achieve Hb concentrations within the target range of 10 to 12 g/dl. Of the 11 pat ients (15%) who failed to achieve the target Hb range, none were consi dered to be nonresponders as they were excluded for unrelated reasons prior to week 16 (8 cases), or were iron deficient (2 cases), or had b leeding complications (1 patient). Maintaining the Hb concentration at a level of 10.5 g/dl required a mean r-HuEPO dose of 92 U/kg per week . Adverse events were generally mild or moderate. The most commonly re ported were hypertension (8%), viral infection / including flu-like sy ndrome (7%), nausea (7%). and dizziness (5%). Statistically significan t increases in mean creatinine concentrations observed after 12 and 24 weeks were most likely due to the progression of renal disease. These results confirm that 50 U/kg of r-HuEPO given 3 times per week subcut aneously provide a safe and effective therapy for anemic predialysis p atients.