title: Efficacy and tolerability of recombinant human erythropoietin treatment in pre-dialysis patients: results of a multicenter study.
abstract: Chronic renal failure is characterized by a normochromic normocytic anemia, the severity of which generally increases during progression toward uremia. The purpose of the study was to evaluate the efficacy and safety of recombinant human erythropoietin (rHu-EPO) given subcutaneously (s.c.), the dose required to reach and maintain Hb levels within 10 and 11 g% and its effects, if any, on the progression of chronic renal failure. Eighty-four pre-dialysis patients (46 F, 38M, age 61.7+/-13.9 years) with Hb levels between 6 and 9 g% and serum creatinine ranging from 3 to 9 mg/dl were treated with s.c. rHu-EPO (2000 U/twice weekly). After 6 weeks, if Hb increase was below 1 g%, 1000 U of s.c. rHu-EPO were added at each administration (3000 U twice weekly). Once the Hb target was reached (10-11 g%), the rHu-EPO weekly dose was halved and administration reduced to once weekly. The patients showed a significant rise in mean Hb values (p<0.001) after 3 months. Mean Hb values were as follows: 8.00+/-0.77 g% (pretreatment), 9.35+/-1.0 (3rd month), 10.06+/-1.04 (6th month), 10.25+/-0.62 g% (12th month). The mean rHu-EPO doses were 4000 U/w (start of the study), 3592+/-1685 U/w (6th month), 2840-/+1178 U/w (12th month). Renal function was evaluated by plotting the reciprocal of serum creatinine values vs time with a two period comparison: period A (retrospective-8 mo); period B (prospective-12 mo). The residual renal function was not impaired by rHu-EPO therapy. Meanwhile, no relevant modifications were observed in mean blood pressure values. Low doses of s.c. rHu-EPO were well tolerated, safe and effective; this therapeutic approach should therefore be considered for the improvement of anemia in pre-dialysis patients. A slow and gradual correction of anemia induces an improved sense of well being and a more active of life style.
authors.affiliation: Department of Nephrology and Dialysis, University G. D'Annunzio, Chieti, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Albertazzi
authors.forename: L
authors.initials: L
authors.lastname: Di Liberato
authors.forename: F
authors.initials: F
authors.lastname: Daniele
authors.forename: V
authors.initials: V
authors.lastname: Battistel
authors.forename: L
authors.initials: L
authors.lastname: Colombi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000150:complications / Q000188:drug therapy*; D001794:Blood Pressure / Q000187:drug effects; D003404:Creatinine / Q000097:blood; D016903:Drug Monitoring; D004361:Drug Tolerance; D004921:Erythropoietin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D007279:Injections, Subcutaneous; D007676:Kidney Failure, Chronic / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D006435:Renal Dialysis
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D003404:Creatinine