Efficacy and safety of epoetin beta in dialysis patients

Introduction . Effective treatment of renal anaemia is achieved due to the use of erythropoietin-stimulating agents, which not only increase haemoglobin levels, but also significantly improve the prognosis for cardiovascular diseases in patients on haemodialysis. Aim . To evaluate the safety and tolerability of Russian recombinant human erythropoietin beta (Epostim®) intended for intravenous administration to maintain stable haemoglobin levels in patients with chronic renal anaemia on programmed haemodialysis. Materials and methods . A retrospective study included 67 patients with end-stage kidney disease on renal replacement therapy by programmed haemodialysis. Results and discussion . Haemoglobin levels at the initiation of treatment (1 month) with epoetin beta and at the end of treatment (12 months) were 106.3 ± 9.0 and 107.4 ± 10.2 g/l, respectively, p = 0.03. The average number of patients with haemoglobin level < 110 g/l in the first 12 months during therapy with epoetin alfa was 8.5 ± 1.1. The average number of patients with haemoglobin level < 110 g/L in the following 12 months (during treatment with epoetin beta) was 6.1 ± 0.5, p = 0.04. The average number of patients with increased haemoglobin levels > 130 g/l in patients treated with epoetin alfa and epoetin beta did not differ from each other and amounted to 4.3 ± 0.6 and 5.1 ± 0.9, respectively, p = 0.46. After conversion to epoetin beta, the changes in haemoglobin levels were much smoother (Friedman test, p = 0.29). The frequency of first-year dose modifications (epoetin alfa) was 2.1 ± 0.12 episodes per year, and that of second-year dose modifications (epoetin beta) was 1.7 ± 0.16 episodes per year, p < 0.047. Epostim® showed good tolerability; no adverse effects, including serious ones, were reported. Conclusion . The use of epoetin beta (Epostim®) allows to effectively maintain a stable haemoglobin level that was achieved after the use of other erythropoietin agents in the treatment of anaemia associated with end-stage chronic renal failure.