Premium
Adverse Events of Subcutaneous Recombinant Human Erythropoietin Therapy: Results of a Controlled Multicenter European Study
Author(s) -
Klinkmann Horst,
Wieczorek Lothar,
Scigalla Paul
Publication year - 1993
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1111/j.1525-1594.1993.tb00571.x
Subject(s) - erythropoietin , recombinant dna , adverse effect , medicine , multicenter study , intensive care medicine , randomized controlled trial , biology , biochemistry , gene
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.