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DSL-011 Efficacy and Safety of Epoetin Zeta in Dialysis Patients
  1. J Bajraktar1,
  2. B Lazarova2,
  3. E Najdovska3,
  4. L Mihajlova2
  1. 1Institute of nephrology, Hospital Pharmacy, Struga, FYROM
  2. 2Clinical Hospital, Hospital Pharmacy, Stip, FYROM
  3. 3Clinical Hospital, Hospital Pharmacy, Bitola, FYROM

Abstract

Background Anaemia in chronic kidney disease (CKD) remains one of the predictable and modifiable non-traditional cardiovascular risk factors. Epoetin zeta, which is a biosimilar product, is used in the treatment of anaemia associated with chronic kidney disease.

Purpose This study was performed to evaluate the efficacy and safety of the biosimilar product epoetin zeta to maintain stable haemoglobin levels in dialysis patients.

Materials and Methods This study was conducted in 2 dialysis centres with 33 patients. Before the study 30 of the 33 patients were on various erythropoiesis-stimulating agents (ESA). After a run-in period of 2 months, all patients were switched to epoetin zeta and were followed for 6 months. The initial weekly doses as well as the frequency of use per week were kept constant (1–3 times/week). During the follow-up, haemoglobin levels, iron status, dialysis efficiency, body weight and adverse events were monitored at least once a month.

Results 33 patients were treated with biosimilar Epoetin zeta (27 men and 6 women); average age 59.1 (28–76) years; the frequency of used was 1–3 doses/week subcutaneously, over a period of 6 months. Dosing was to be adjusted to keep the Hb levels within 10.5–12 g/dl. Anaemia management and iron supplementation were at the discretion of the investigator and was to be in compliance with the current label. Throughout this study epoetin zeta was within the target range for Hb levels (10.5–11.5 g/dl ± 0.5 g/dl). The main AEs (adverse events) were in 1 patient hypotension (3%), in 1 patient in-dialyzer clotting (3%) and SAE (serious adverse event) was in 1 patient thrombosis of arteriovenous fistula (AVF) (3%). No anti-epoetin antibodies and no clinical signs of pure red cell aplasia (PRCA) were observed in any patients on the study.

Conclusions Treatment of anaemia with Epoetin zeta was shown to be effective and safe. The mean Epoetin zeta doses remained stable in patients switched from all pre-study ESAs. The observed adverse events profile was in line with expectations for the study population.

No conflict of interest.

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