Dialysis patients treated with Epoetin alfa show improved anemia symptoms: A new
analysis of the Canadian Erythropoietin Study Group trial.
Author(s): Keown PA, Churchill DN, Poulin-Costello M, Lei L, Gantotti S, Agodoa I, Gitlin M,
Gandra SR, Mayne TJ.
Affiliation(s): University of British Columbia, Vancouver, Canada. keown@interchange.ubc.ca
Publication date & source: 2010, Hemodial Int. , 14(2):168-73
The health-related quality of life (HRQOL) claims in the current Epoetin alfa
label are based on the reanalyses of the exercise and physical function data from
the Canadian Erythropoietin Study Group trial. The reanalysis was done to comply
with the Food and Drug Administration's requirement of using statistical methods
that are currently standard in evaluating clinical trial data. Presented here are
HRQOL results associated with anemia. The Canadian Erythropoietin Study Group
trial was a multicenter, double blind, randomized, placebo-controlled trial
evaluating the effects of Epoetin alfa on HRQOL in anemic hemodialysis patients.
A total of 118 patients who were 18-75 years old, on hemodialysis for >3 months,
who had a hemoglobin <9.0 g/dL, and did not have coronary artery disease or
diabetes mellitus, were randomized to either receive placebo (n=40), or receive
intravenous Epoetin alfa to achieve a target hemoglobin of 9.5-11.0 g/dL (n=40)
or a target of 11.5-13.0 g/dL (n=38). Patients were followed for 6 months. The
two Epoetin alfa-treatment groups were combined for all analyses performed. This
post hoc analysis was conducted using an intent-to-treat repeated measures mixed
model analysis of variance using Bonferroni's multiplicity correction. The
Epoetin alfa-treated group showed a statistically significant improvement in the
Kidney Disease Questionnaire symptom of fatigue in comparison with placebo.
Additionally, the change in hemoglobin at 2 months was correlated with change in
fatigue, energy, shortness of breath, and weakness, but had minimal effect on
depression. These analyses confirm previously reported results, which indicate
that treating hemodialysis patients with an erythropoiesis-stimulating agent
improves HRQOL.
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