HEALTH-RELATED QUALITY-OF-LIFE ASSOCIATED WITH RECOMBINANT-HUMAN-ERYTHROPOIETIN THERAPY FOR PREDIALYSIS CHRONIC RENAL-DISEASE PATIENTS

The investigators evaluated the impact of recombinant human erythropoi etin (r-HuEPO) therapy on health-related quality of life (HRQL) in pre dialysis chronic renal disease patients with anemia. Eighty-three pati ents were entered into a randomized, parallel-group, open-label clinic al trial with follow-up evaluations over 48 weeks. Forty-three patient s were assigned to r-HuEPO treatment, and 40 patients were assigned to an untreated control group. Hematocrit levers were measured at baseli ne and monthly. HRQL was assessed at baseline and at weeks 16, 32 and 48. The HRQL assessment included measures of physical function, energy , role function, health distress, cognitive function, social function, home management, sexual dysfunction, depression, and life satisfactio n. Significant improvements in hematocrit levels were observed in the r-HuEPO-treated group (P < 0.0001), and no changes were seen in the un treated group. Correction of anemia (hematocrit greater than or equal to 36) occurred in 79% of r-HuEPO-treated patients and 0% of control p atients. Significant improvements in assessments of energy (P < 0.05), physical function (P < 0.05), home management (P < 0.05), social acti vity (P < 0.05), and cognitive function (P < 0.05) were found for the r-HuEPO-treated group. No changes were observed in the control group, except for a decrease in physical function (P < 0.05). Between-group d ifferences favoring the r-HuEPO-treated group were found for energy (P < 0.05) and physical functioning (P < 0.05). In patients receiving r- HuEPO, significant improvements were seen in hematocrit levels, and th ese increases resulted in improvements in HRQL. (C) 1995 by the Nation al Kidney Foundation, Inc.