Nissenson AR, Lindsay RM, Swan S, Lambrecht LL, Seligman P
Ferric gluconate (Ferrlecit) is safe and effective in
hemodialysis patients: North American trial
Am Soc Nephrol
J Am Soc Nephrol (abstract)
(Sep) 7:1459 1996
The use of intravenous iron dextran has increased significantly in the past
year in an effort to improve anemia management for hemodialysis patients.
This drug has been associated with occasional serious adverse reactions
which
has led to an interest in using other intravenous iron formulations. Ferric
gluconate has been available in Europe for many years, and anecdotal reports
indicate that it appears to have a good safety profile. Allergic reactions
to
iron dextran have probably been due to the dextran portion of the molecule,
therefore, ferric gluconate may cause less allergy. Physical chemistry
studies, however, indicate that ferric gluconate does not bind iron as
tightly as iron dextran. Therefore, the risk of premature iron release
leading to oversaturation of plasma transferrin and parenchymal iron
deposition has been a concern. This study by Nissenson et al is the first
American evaluation of the drug.
90 iron deficient hemodialysis patients at 3 centers were randomly assigned
to a prospective study of either 500 mg or 1,000 mg of ferric gluconate over
8 hemodialysis treatments. The mean Hct increased from 29% to 33%, the mean
ferritin from 86 ng/ml to 139 ng/ml, and the mean transferrin saturation
from
16% to 21%. No changes in EPO dose was made during the study. There was one
adverse reaction probably attributable to the drug. The authors concluded
that the drug was safe and effective.
Comment: This was a well designed and performed study, indicating the
potential of this drug. Certainly an experience with a much larger number of
patients will be needed to fully evaluate the drug's efficacy and safety.
The
issue of transferrin oversaturation with this drug (and the lower risk with
iron saccharate and dextran) has recently come up in the European literature
(and this year's ASN - see
review of A1257
). This study does not
demonstrate evidence of this phenomenon.
(Stephen Fishbane, M.D., Winthrop University Hospital, Mineola, NY)
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Am Soc Nephrol
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