• Jolanta Malyszko, Maciej Drozdz, Agnieszka Zolkiewicz, and Boleslaw Rutkowski.
• Department of Nephrology and Transplantology, Medical University, Zurawia 14, 15-540, Bialystok, Poland, jolmal@poczta.onet.pl.
• Int Urol Nephrol. 2014 Jan 1;46(1):71-82.

BackgroundChronic kidney disease is almost always accompanied by anaemia. Erythropoietin-stimulating agents (ESA) can increase haemoglobin concentration and thus reduce the frequency of anaemia-related complications including the cardiovascular events.AimThe aim of the study was to collect prospective data on 12-month standard ESA therapy used in haemodialyzed patients in selected CEE countries as well as on cardiovascular complications, iron status and anaemia treatment.Patients And MethodsFifty centres in 3 countries participated in the study. A group of 398 haemodialysed stable patients (M-231, F-167) aged 19-90 years (57.5 ± 14.7) on standard ESA therapy for chronic renal anaemia were recruited. Twelve-month prospective data on iron parameters, ESA therapy and cardiovascular events were collected. The use of iron, folic acid and blood transfusions were also assessed. Patient were divided into three groups according to ESA therapy start: group A-patients who received ESA after start of haemodialysis, group B-patients who received ESA within 3 months from the day of first haemodialysis and group C-patients who had received ESA more than 3 months before haemodialysis. Chi(2) test for qualitative data and Kruskall-Wallis test for quantitative data with p < 0.05 were used in statistical analysis.ResultsAt prestudy period, the mean weekly dose of ESA in group C was statistically lower than in the remaining two groups (3,823 ± 3,169 vs. 5,276 ± 2,915 and 6,427 ± 3,441 units/week, p < 0.001), but during prospective phase of the study the doses did not differ among groups A, B and C. No major fluctuation of ESA administration schedule was observed during the study in the groups; however, at majority of visits, the mean frequency of ESA administration in group C was statistically higher than in groups A and B. At baseline visit, the haemoglobin concentration in group A patients (10.86 ± 1.34 g/dL) was slightly lower than in group B (11.26 ± 1.43 g/dL) and group C (10.98 ± 1.35 g/dL) (p = 0.025), but at subsequent visits these differences disappeared and mean haemoglobin concentration was stable around 11 g/dL. Ferritin concentration increased from 280 ± 241 at baseline to 506 ± 405 at month 12, and no important differences in the groups were observed. The other haematological parameters (haematocrit, iron concentration) remained stable during the entire study. The frequency of blood transfusion and total volume of blood in group C were lower than in groups A and B. During the prospective 12-month follow-up, 23 (5.8 %) of the patients died and 35 (8.8 %) were transplanted. No differences in death or transplantation rate were observed among groups A, B and C. The number of patients with adverse events, serious adverse events or drug-related adverse events in all groups was similar. In conclusion, ESA therapy increased haemoglobin concentration and no major differences in haematological parameters among the groups were observed during the entire study irrespective of early versus late start. Mortality, cardiovascular events or other adverse events were similar among the groups during the observation period; however, the limitation of the study is the sample size.

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