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Titre du document / Document title

Methoxy Polyethylene Glycol-Epoetin Beta : A Review of its Use in the Management of Anaemia Associated with Chronic Kidney Disease

Auteur(s) / Author(s)

CURRAN Monique P. (1) ; MCCORMACK Paul L. (1) ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

(1) Wolters Kluwer Health I Adis, Auckland, NOUVELLE-ZELANDE

Résumé / Abstract

Methoxy polyethylene glycol-epoetin beta (Mircera®) is a continuous erythropoietin receptor activator, with a long half-life (approximately 130 hours). In patients with anaemia associated with chronic kidney disease (CKD), both on and not on dialysis, who had not previously received an erythropoiesis-stimulating agent (ESA), methoxy polyethylene glycol-epoetin beta administered intravenously or subcutaneously once every 2 weeks resulted in a smooth and steady rise in haemoglobin levels. The response rates were high (up to 97.5%) in these patients at the end of the correction period; response rates with the comparator ESAs (epoetin alfa or beta, or darbepoetin alfa) were up to 96.3%. Moreover, patients with CKD on dialysis who had previously been treated with an ESA maintained stable haemoglobin levels (within ±1 g/dL of baseline and within a range of 10-13.5 g/dL) when directly converted to methoxy polyethylene glycol-epoetin beta administered intravenously or subcutaneously once every 2 or 4 weeks. Methoxy polyethylene glycol-epoetin beta is generally well tolerated, with most adverse events being of mild to moderate severity, consistent with the co-morbidities known to occur in this patient group and those reported with other ESAs. In conclusion, in patients with anaemia associated with CKD, subcutaneous or intravenous methoxy polyethylene glycol-epoetin beta achieved a high haemoglobin response rate (ESA-naive patients) when administered once every 2 weeks and maintained stable haemoglobin levels (patients previously treated with ESAs) when administered once monthly. Methoxy polyethylene glycol-epoetin beta is a continuous erythropoietin receptor activator, with a slower association with, but slightly faster dissociation from, the erythropoietin receptor than epoetin beta. Cell stimulation studies demonstrated that this agent has a reduced in vitro, but an increased in vivo, specific activity compared with epoetin beta. Subcutaneous or intravenous administration of methoxy polyethylene glycol-epoetin beta produced a dose-dependent reticulocyte response in patients with CKD that was independent of the frequency of administration. Following subcutaneous administration of methoxy polyethylene glycol-epoetin beta to anaemic patients with CKD, both on and not on dialysis, maximum serum concentrations (Cmax) occurred after a median 72.0 and 94.5 hours. Times to Cmax after intravenous administration of this agent were 2.0 and 0.25 hours. After subcutaneous administration, absolute bioavailabilities were 62% and 54%, respectively. Haemodialysis had no effect on the serum concentrations of methoxy polyethylene glycol-epoetin beta. Clearance was low (0.49-1.67 mL/h/ kg) and the mean terminal elimination half-life was long (77-142 hours) following subcutaneous or intravenous administration. Six phase III trials have demonstrated the efficacy of methoxy polyethylene glycol-epoetin beta administered subcutaneously or intravenously once every 2 weeks or once every 4 weeks in patients aged ≥18 years with anaemia associated with CKD, both on and not on dialysis.

Revue / Journal Title

Drugs    ISSN  0012-6667   CODEN DRUGAY 

Source / Source

2008, vol. 68, no8, pp. 1139-1156 [18 page(s) (article)] (66 ref.)

Langue / Language

Anglais

Editeur / Publisher

Adis International, Auckland, NOUVELLE-ZELANDE  (1962) (Revue)

Mots-clés anglais / English Keywords

Kidney disease

;

Urinary system disease

;

Renal failure

;

Hemopathy

;

Antianemia agent

;

Intravenous administration

;

Subcutaneous administration

;

Chronic kidney disease

;

Anemia

;

Clinical management

;

Bibliographic review

;

Review

;

Epoetin beta

;

Ethylene oxide polymer

;

Mots-clés français / French Keywords

Pathologie du rein

;

Pathologie de l'appareil urinaire

;

Insuffisance rénale

;

Hémopathie

;

Agent stimulant l'érythropoïèse

;

Antianémique

;

Voie intraveineuse

;

Voie souscutanée

;

Néphropathie chronique

;

Anémie

;

Conduite à tenir

;

Revue bibliographique

;

Article synthèse

;

Epoétine bêta

;

Ethylène oxyde polymère

;

Mots-clés espagnols / Spanish Keywords

Riñón patología

;

Aparato urinario patología

;

Insuficiencia renal

;

Hemopatía

;

Agente antianémico

;

Vía intravenosa

;

Vía subcutánea

;

Nefropatía crónica

;

Anemia

;

Actitud médica

;

Revista bibliográfica

;

Artículo síntesis

;

Epoetina beta

;

Etileno óxido polímero

;

Localisation / Location

INIST-CNRS, Cote INIST : 15326, 35400019758649.0090

Nº notice refdoc (ud4) : 20474832



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