Conventional treatment with epoetin (a synthetic form of human erythropoietin that promotes red-blood cell production) to manage anaemia in chronic kidney disease needs frequent administrations (at least weekly), changes of dose, and close monitoring of haemoglobin concentrations.
Dr Nathan Levin, Renal Research Institute, New York, USA, and colleagues compared the effectiveness of a long-acting erythropoieses-stimulating agent variant of epoetin (methoxy polyethylene glycol-epoetin beta), given intravenously at 2-week or 4-week intervals, with epoetin treatment one to three times per week for haemoglobin control in haemodialysis patients. The study was designed so that all patients (673 in total, from North America and Europe) received conventional epoetin treatment initially; after four weeks a third of individuals were given methoxy polyethylene glycol-epoetin beta every two weeks, another third given methoxy polyethylene glycol-epoetin beta every four weeks, with the remaining third continuing to receive conventional epoetin treatment throughout the trial..
Haemoglobin concentrations were recorded at baseline, throughout the study, and at a final assessment which took place around a mean of 42 weeks after baseline. The main result of the study showed how individuals given methoxy polyethylene glycol-epoetin beta either fortnightly or every four weeks had no statistically significant change in haemoglobin concentrations compared with those who remained on mainly a three-times-a-week regimen of epoetin treatment throughout the study. Adverse outcomes were minimal and similar between the epoetin and methoxy polyethylene glycol-epoetin beta treatment arms.
Dr Levin comments: “Errors with medication occur at an unacceptably high rate of 45%. Extrapolation to about 246000 haemodialysis patients in the USA suggests that 111000 dose errors could happen every month. Treatment with methoxy poly-ethylene glycol-epoetin beta every 4 weeks would need only 13 doses per year, compared with 52–156 doses with conventional epoetin, and would therefore allow fewer opportunities for error. Since our findings show that haemoglobin can be controlled in all dialysis patients with methoxy polyethylene glycol-epoetin beta given every 4 weeks, we advise that this drug should be introduced as an option to epoetin for simplified anaemia management.”
In an accompanying Comment, Dr Rowan Walker, Royal Melbourne Hospital and Monash University Alfred Hospital, Melbourne, Australia, and Dr Giovanni Strippoli, University of Sydney, Australia, and Mario Negri Sud Consortium, Chieti, Italy, say: “Before we can concur on a precise clinical role for this molecule, we need to explore issues other than simply the non-inferiority with other epoetins to reach certain unvalidated surrogates. Different does and molecular characteristics of epoetins may affect patient-level endpoints, independent of achieved haemoglobin. When these issues are examined, we might be truly confident that a newer molecule is non-inferior to existing ones.”
Tony Kirby | alfa
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