Iron sucrose in hemodialysis patients: safety of replacement and maintenance regimens.
BACKGROUND
Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicenter phase IV clinical trial examined the safety of iron sucrose for the treatment of iron deficiency and for the maintenance of iron sufficiency in hemodialysis patients.


METHODS
In this safety study, iron sucrose was given in two dosing regimens. Iron deficient patients were treated with intravenous iron sucrose, 100 mg, during 10 consecutive hemodialysis sessions (replacement regimen). Iron replete patients were given iron sucrose, 100 mg intravenous (iv) over 5 minutes, weekly for 10 weeks (maintenance regimen). At the end of each 10-dose cycle, iron status was reassessed, and dosing during the subsequent cycle was based on the adequacy of iron stores as per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines. With each dosing regimen, adverse events, if any, were recorded and described.


RESULTS
Six hundred and sixty-five hemodialysis patients, including 80 who had experienced previous intolerance to other parenteral iron preparations, received a total of 8583 doses of iron sucrose. One hundred eighty-eight patients received more than one iv iron cycle (replacement, maintenance, or both). There were no serious or life-threatening drug-related adverse events.


CONCLUSIONS
Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores.
Aronoff
George R
GR
University of Louisville School of Medicine, Louisville, Kentucky, USA.
Bennett
William M
WM
Blumenthal
Samuel
S
Charytan
Chaim
C
Pennell
J Phillip
JP
Reed
John
J
Rothstein
Marcos
M
Strom
James
J
Wolfe
Anthony
A
Van Wyck
David
D
Yee
Jerry
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D004342:Drug Hypersensitivity / Q000175:diagnosis; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000401:mortality / Q000628:therapy; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D018805:Sepsis / Q000401:mortality
D005290:Ferric Compounds; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid