An evaluation of the efficacy and safety of the new domestically produced epoietin α produced in Russia <i>A review and report of an open multicenter study</i>
The results of observational studies and clinical trials have formed a contemporary view on the anemia correction targets in patients with chronic kidney disease. However some questions remain unsolved and are the subject of active discussion which are presented in a short review. Expansion of available drugs which stimulate erythropoiesis arise additional concern about their bioequivalence (dosing, clinical effect, adverse events). This study presents the results of transferring of 51 hemodialysis patients from treatment with original epoietin α and β to the treatment with the same doses of Eralfon - a new pharmaceutical dosage formulation of epoietin α in pre-filled syringes produced by ZAO «Sotex» out of pharmacological substance manufactured by the State Scientific Research Institute of Highly Pure Biopreparations (St.-Petersburg). Eralfon was injected intravenously. After changing the drugs the hemoglobin level in the whole group remained the same (117 ± 6 g/l vs 116 ± 6 g/l); individual changes were also not significantly different from zero: the mean hemoglobin level change was -0,46 g/l (95% CI -1,79.+0,84), р = 0,46. The mean baseline weekly epoietin dose was 5118 ± 2819 IU/week and did not differ from mean final Eralfon dose 5034 ± 2719 IU/week (р > 0,5). There was neither adverse event related to investigated new drug nor individual intolerability or allergic reactions in a short-term study. The blood pressure level was also stable.