A Comparison Between Epoetin Omega and Epoetin Alfa in the Correction of Anemia in Hemodialysis Patients: A Prospective, Controlled Crossover Study

Abstract

The objective of the study was to evaluate and compare the safety and effectiveness of epoetin omega (produced in baby hamster kidney cells) and epoetin alfa (produced in Chinese hamster ovary cells) in sustaining the correction of anemia in maintenance hemodialysis patients. The study, a prospective and controlled crossover, was completed in 38 stable patients treated with both epoetins for 24 weeks. Group A (17 patients) started with epoetin omega, and Group B (21 patients) started with epoetin alfa. After 24 weeks, a 4 week crossover (wash out) was made: Group A was switched to epoetin alfa and group B to epoetin omega for the next test period of 24 weeks. Both epoetins were administered subcutaneously after each dialysis. Doses were adjusted with the aim of maintaining a target hemoglobin level between 10 and 12 g/dl (hematocrit 30% to 35%). The mean weekly dose of epoetin omega/kg body weight (BW) was 67 +/- 43 U. The mean weekly dose of epoetin alfa/kg BW was 86 +/- 53 U. The average of all mean values of hemoglobin (Hb) during treatment with epoetin omega was 11.4 +/- 0.7 g/dl (hematocrit 34 +/- 2%), and during treatment with epoetin alfa was 11.3 +/- 0.7 g/dl (hematocrit 33 +/- 2%) (not significant). Thromboses of vascular access occurred in 3 patients during an epoetin omega treatment and in 3 patients during epoetin alfa treatment. At the site of injection, only 1 patient described a mild pain when treated with epoetin omega and only 6 patients when treated with epoetin alfa. In conclusion, both epoetin omega and epoetin alfa were effective in correcting the anemia of all studied patients. However, lower doses of epoetin omega were needed to maintain the same target hemoglobin level. No serious side effects with either epoetin were noted. The authors believe that additional comparisons of different epoetin preparations should be performed and will provide better insight into their biological activity and clinical responsiveness.

Emerging erythropoiesis-stimulating agents

“…52 Although only a small number of patients with CKD treated with epoetin omega have been evaluated within long-term controlled trials, the experience to date suggests that epoetin omega is as effective in correcting anemia as epoetin alfa and epoetin beta. [53][54][55] recombinant human erythropoietin isoforms with a greater number of sialic residues have longer half-lives and greater biological activity in vivo than those with fewer resi dues. 56 Most sialic acid residues are attached to the three N-linked glycosylation chains; thus, site-directed mutagenesis targeting amino acids not involved in erythropoietin receptor binding has been used to synthesize analogues with increased amounts of sialic acid.…”

Development of Recombinant Erythropoietin and Erythropoietin Analogs

“…Other epoetins that have recently become available or are still being developed include epoetin omega (Acharya et al, 1995;Bren et al, 2002;Sikole et al, 2002) and epoetin delta (Spinowitz and Pratt, 2006;Kwan and Pratt, 2007;Martin, 2007). As with all recombinant human erythropoietins, these products share the same amino acid sequence as for epoetin alfa and epoetin beta, as well as the endogenous hormone.…”

The development of erythropoietic agents in oncology

“…The results will determine the feasibility and expense of generic ESP development. A new rHuEPO preparation recently acquired by Baxter, expressed in young hamster kidney cells, named epoetin-ω, has undergone clinical trials in nephrology [80,81] and is being marketed in a small number of eastern European countries; given the upcoming patent expiration, this preparation may be the first agent to test western Europe's new generic development guidelines. There has not been a patent ruling in the US regarding this agent.…”