doiSerbia

Comparative study of the efficacy of different regimens of intermittent subcutaneous dosing of erythropoietin β in treatment of renal anemia in chronic dialysis patients

Nešić Vidosava (Klinički centar Srbije, Institut za nefrologiju i urologiju, Beograd)
Oštrić Vladimir (Klinički centar Srbije, Institut za nefrologiju i urologiju, Beograd)
Kovačević Zoran (Vojnomedicinska akademija, Klinika za nefrologiju, Beograd)
Dimković Nada (KBC "Zvezdara", Institut za bubrežne bolesti i metaboličke poremećaje, Beograd)
Čurić Slobodan (Klinički centar 'Novi Sad', Institut za interne bolesti, Novi Sad)
Lazarević Marina (Klinički centar 'Kragujevac' - Klinika za internu medicinu, Kragujevac)
Ratković Marina (Klinički centar Crne Gore, Klinika za urologiju i nefrologiju, Podgorica)
Bogdanović Jasmina (Zdravstveni centar Valjevo)
Jelačić Rosa (Opšta bolnica, Zrenjanin)

Introduction. 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. Material and methods. An open, comparative, multicenter study was divied 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 fig/l and transferring 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 transplanted 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 perprotocol 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. Conclusion 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. .

Keywords: erythropoietin, recombinant + administration and dosage, anemia + therapy, kidney failure, injections, subcutaneous