If a patient with severe kidney disease took an anti-anemia drug just once per month to raise hemoglobin concentration his/her quality of life could be significantly improved. According to an article in the medical journal The Lancet this simplified anemia management appears to give similar results to conventional therapy for treating anemia, which involves much more frequent use of a synthetic form of human erythropoietin (epoetin) the promotes red-blood cell production.

Treatment with epoetin requires at least weekly administration, changes of dose, and careful monitoring of hemoglobin concentrations.

Dr Nathan Levin, Renal Research Institute, New York, USA, and team looked at how effective a long-acting erythropoieses-stimulating agent variant of epoetin (methoxy polyethylene glycol-epoetin beta) might be when administered intravenously at two or four week intervals, and compared the treatment to epoetin treatment which was administered up to three times per week – for hemoglobin control in hemodialysis patients.

In this study, all the 673 patients received conventional epoetin treatment to start with – all the patients were from Europe and North America. Four weeks into the study one third of them received methoxy polyethylene glycol-epoetin beta once every two weeks, another third received methoxy polyethylene glycol-epoetin beta once every four weeks, while the other third continued being given conventional epoetin treatment for the rest of the trial.

Hemoglobin concentrations, which were recorded at baseline, were regularly monitored throughout a 42 week period. The researchers found that those being given methoxy polyethylene glycol-epoetin either once every two weeks or every four weeks had similar hemoglobin concentrations to those who continued having a three-times-a-week regime of epoetin treatment during the whole study. Adverse outcomes were similar in all the three groups.

“Errors with medication occur at an unacceptably high rate of 45%. Extrapolation to about 246 000 haemodialysis patients in the USA suggests that 111 000 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 hemoglobin 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 anemia management,” Dr Levin explained.

Accompanying Comment

“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 hemoglobin. When these issues are examined, we might be truly confident that a newer molecule is non-inferior to existing ones,” 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, wrote in an Accompanying Comment.

“Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis”
N W Levin and others

“A pegylated epoetin in anaemia of renal disease: non-inferiority for an unvalidated surrogate”
R G Walker, G F M Strippoli

The Lancet Volume 370 • Number 9596 • October 20-26, 2007

Written by: Christian Nordqvist