Intravenous iron sucrose versus oral iron supplementation for the treatment of iron deficiency anemia in patients with inflammatory bowel disease--a randomized, controlled, open-label, multicenter study.
OBJECTIVE
Anemia is a frequent complication in patients with inflammatory bowel disease (IBD). The optimal route for iron supplementation to replenish iron stores has not been determined so far. We therefore evaluated the efficacy and safety of intravenous iron sucrose as compared with oral iron sulfate for the treatment of iron deficiency anemia (IDA) in patients with IBD.


METHODS
A randomized, prospective, open-label, multicenter study was performed in 46 patients with anemia and transferrin saturation <or=20% and/or serum ferritin concentrations <or=20 microg/L. The intravenous group received a single dose of iron sucrose of 7 mg iron/kg body weight, followed by five 200 mg infusions for the following 5 wks. The oral group received iron sulfate 100-200 mg per day for 6 wks.


RESULTS
While a comparable increase in hemoglobin was observed for both administration routes (median increase 0.25 g/L in the intravenous group vs 0.21 g/L in the oral group), only iron sucrose led to a rise in serum ferritin concentrations. Intractable gastrointestinal adverse events caused permanent study drug discontinuation in five patients (20.8%) receiving iron sulfate, whereas only one patient (4.5%) had to be withdrawn because of side effects due to iron sucrose.


CONCLUSIONS
Although being equal in short-term efficacy and overall tolerability our results suggest a better gastrointestinal tolerability for iron sucrose. Larger trials are mandatory to prove a possible advantage of iron sucrose in short- and long-term efficacy as well as in tolerability over iron sulfate in the management of IDA in IBD.
Schröder
Oliver
O
First Department of Internal Medicine, Division of Gastroenterology, ZAFES, Johann Wolfgang Goethe-University, Frankfurt, Germany.
Mickisch
Oliver
O
Seidler
Ursula
U
de Weerth
Andreas
A
Dignass
Axel U
AU
Herfarth
Hans
H
Reinshagen
Max
M
Schreiber
Stefan
S
Junge
Ulrich
U
Schrott
Marc
M
Stein
Jürgen
J
D015746:Abdominal Pain / Q000139:chemically induced; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077605:Ferric Oxide, Saccharated; D005293:Ferritins / Q000097:blood; D005500:Follow-Up Studies; D005937:Glucaric Acid; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000097:blood / Q000150:complications*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011446:Prospective Studies; D014168:Transferrin / Q000032:analysis; D016896:Treatment Outcome
D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; D014168:Transferrin; C024823:ferric sulfate; D005293:Ferritins; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid