Dosing regimen and tolerability of methoxy polyethylene glycol-epoetin beta in Chinese dialysis patients

摘要

Abstract: Aim To investigate methoxy polyethylene glycol-epoetin beta dosing regimen in treatment na?ve subjects and dose conversion in darbepoetin alpha treated subjects, in Chinese dialysis patients. Methods Adult Chinese patients on peritoneal dialysis (PD) or haemodialysis (HD), with no prior treatment with erythropoiesis-stimulating agents and haemoglobin below 8 g/dL (Group I) or receiving darbepoetin alpha and had stable haemoglobin at 10-12 g/dL (Group II) were included in this prospective open-label study. In Group I methoxy polyethylene glycol-epoetin beta was started at 0.6 μg/kg subcutaneously fortnightly till haemoglobin reached 10 g/dL, after which it was given monthly. A dose conversion table was devised for Group II. Follow-up was 36 weeks. Results Forty-five patients were included. Haemoglobin in Group I (n = 23, PD/HD:19/4) increased from 7.5 ± 0.9 g/dL at baseline to 10.7 ± 1.0 g/dL after 16 weeks, while it remained stable at 10.4 ± 1.0 g/dL after conversion in Group II (n = 22, PD/HD:15/7). Actual dose required after stabilization was 1.7 μg/kg per month in Group I and 2.3 μg/kg per month in Group II. Median number of dose adjustment was three in Group I and one in Group II, while haemoglobin overshoot to 13 g/dL or above occurred in 4.4% and 9.1%, respectively. No significant side-effect was observed. Conclusions Our dosing regimen for methoxy polyethylene glycol-epoetin beta, for treatment na?ve subjects or for conversion from darbepoetin alpha, is safe and effective. The dose required to achieve a haemoglobin concentration of 10-11 g/dL in Chinese dialysis patients is approximately 2 μg/kg monthly. Summary at a Glance This two-part open label study establishes: (i) a safe effective initiating regime for methyl polyethylene glycol epoetin beta in ESA-naive Chinese dialysis patients; and (ii) an effective regime for dose conversion from darbepoetin alpha to methyl polyethylene glycol epoetin beta in Chinese dialysis patients.