Adverse events of subcutaneous recombinant human erythropoietin therapy: results of a controlled multicenter European study.
In a controlled European multicenter study, clinical tolerance of subcutaneously administered recombinant human erythropoietin (rh-EPO) therapy and its influence on the course of illness in 362 hemodialyzed patients (162 males, 200 females) from 16 European dialysis centers was studied. Of these, 181 patients served as a control group in the first year and received rh-EPO therapy in the second year. Of the 837 adverse events that occurred, 277 were classified as serious and 560 as nonserious. Thirty-two deaths have been reported for the study population: 18 in the control group and 14 in the therapy group. The individual analysis of the serious adverse events including death demonstrates a protective effect of rh-EPO on the high-risk cardiovascular situation of dialysis patients. Hypertension was no problem, and under rh-EPO therapy an increase in resistance to infection was observed. Subcutaneous rh-EPO treatment might have an even better safety profile than intravenous application.
Department of Internal Medicine, University of Rostock, Germany.
H
H
Klinkmann
L
L
Wieczorek
P
P
Scigalla
D000328:Adult; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D002318:Cardiovascular Diseases / Q000453:epidemiology; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D007279:Injections, Subcutaneous; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects*; D006435:Renal Dialysis
D011994:Recombinant Proteins; D004921:Erythropoietin