[Comparative study of the efficacy of different regimens of intermittent subcutaneous dosing of erythropoietin beta in treatment of renal anemia in chronic dialysis patients].
BACKGROUND
The use of erythropoietin (EPO) in the treatment of renal anemia is justified by more than 15 years of experience. Clinical trials have shown that subcutaneous erythropoietin beta (Recormon - F. Hoffmann-La Roche) therapy once weekly, or even once every two weeks has proven successful. The aim of this study was to evaluate the efficacy of different regimes of Recormon therapy in maintaining stable levels of hemoglobin (Hb) and hematocrit (HCT) in hemodialysis patients.


METHODS
An open, comparative, multicenter study was divided into three arms of patients and lasted for 24 weeks. 98 patients with stable Hb level (>100 g/l), were treated with a stable dose of Recormon, and had a ferritin level > 200 microg/l and transferrin saturation >20%. During the first 8 weeks all were on the usual 2-3 times weekly epo dosage. 8 weeks later, 70 patients received epo once weekly, while 28 patients (group 1) maintained the same regimen for the entire study period. After another 8 weeks, 21 of those 70 patients receiving epo once weekly, received it once every two weeks (group 3), while 49 patients continued once weekly regimen to the end of the trial (group 2). The primary efficacy parameter was the percentage of patients maintaining their target Hb and HCT levels (>100 g/l and >30% for HB and HCT respectively).


RESULTS
86 patients (87.75%) completed the study (25 from group 1, 42 from group 2 and 19 from group 3). One patient was excluded because he was transplated during the study, one due to uncontrolled hypertension, while 10 patients, all from the same center, were excluded due to protocol violation (4-week gap in epo therapy due to problems with epo supply). Efficacy analysis included per-protocol population (86 patients). Hb levels remained stable (>100 g/l) in all three groups. Although there were statistically significant differences in Hb levels between visits (p=0,026), there were no statistically significant differences between groups throughout the study (p=0,439). HCT levels remained stable (>30%) in all three groups throughout the study, without statistically significant differences between visits (p=0,053) and between groups (p=0,155). The average epo doses were not statistically significantly different between visits (p=0,676) or between groups (p=0,512). The main tolerability parameters: sitting systolic (SSBP) and diastolic (SDBP) blood pressures were monitored at all visits. Statistical analysis showed that there were no differences in SSBP or SDBP between visits or groups of patients throughout the study.


CONCLUSIONS
All three dosing regimens of subcutaneous epo beta were statistically equivalent in maintaining target Hb and HCT levels. Once weekly or once every two weeks administration of epo beta does not lead to dose increase, and provides greater opportunities to individualize treatment for every single patient and may lead to better compliance.
Nesić
Vidosava
V
Klinicki centar Srbije, Beograd--Institut za nefrologiju i urologiju.
Ostrić
Vladimir
V
Kovacević
Zoran
Z
Dimković
Nada
N
Curić
Slobodan
S
Lazarević
Marina
M
Ratković
Marina
M
Bogdanović
Jasmina
J
Jelacić
Rosa
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008875:Middle Aged; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000009:adverse effects
D011994:Recombinant Proteins; D004921:Erythropoietin