Safety and Efficacy of Methoxy Polyethylene Glycol-epoetin Beta in Anemia Treatment in Patients on Hemodialysis: a Macedonian Experience.

INTRODUCTION

Anemia in patients with chronic kidney disease (CKD) is present in about 50% in pre-dialysis and over 90% of patients on hemodialysis. Erythropoiesis-stimulating agent (ESA) is a standard therapy for renal anemia, but management of anemia in CKD still remains a challenge from the treatment point of view.

AIM: To evaluate safety and efficacy of methoxy polyethylene glycol-epoetin beta as continuous erythropoietin receptor activator (C.E.R.A.) in maintenance of haemoglobin (Hb) concentrations in patients with chronic renal anemia in the routine clinical practice.

METHODS

National, multicenter, observational, prospective study in patients with CKD on hemodialysis for maintenance of Hb levels with once-monthly therapy with C.E.R.A. In 8 dialysis centers 184 adult patients were observed and followed up every month during one year. Total number of enrolled patients was 185 from whom 184 patients were observed and 147 patients were followed for 12 months as 37 dropped out from the study earlier.

RESULTS

Overall mean dose of C.E.R.A. was 115.2 μg with average 4.99 dose modifications per patient. Among 184 patients observed, total number of 121 adverse events (AEs) were identified in 49 of the patients. The most of the AEs were of mild or moderate severity. A few serious AEs were assessed and reported as not related to the drug administration. Mean Hb levels during the study varied but were maintained stable in the range of 100-120 g/l.

CONCLUSION

Safety and tolerability of C.E.R.A. was as expected as the frequency and type of AEs was similar to the known pattern from the studies done in other countries and relevant literature. Hb levels as the primary efficacy parameter of C.E.R.A. treatment were maintained stable within the target range during the study.