Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial.
BACKGROUND
The objective was to evaluate efficacy and safety of rapid, large-dose intravenous (IV) administration of ferric carboxymaltose compared to oral iron in correcting iron deficiency anemia due to heavy uterine bleeding.


METHODS
In a randomized, controlled trial, 477 women with anemia, iron deficiency, and heavy uterine bleeding were assigned to receive either IV ferric carboxymaltose (<or=1000 mg over 15 min, repeated weekly to achieve a total calculated replacement dose) or 325 mg of ferrous sulfate (65 mg elemental iron) prescribed orally thrice daily for 6 weeks.


RESULTS
Compared to those assigned to ferrous sulfate, more patients assigned to ferric carboxymaltose responded with a hemoglobin (Hb) increase of 2.0 g/dL or more (82% vs. 62%, 95% confidence interval for treatment difference 12.2-28.3, p < 0.001), more achieved a 3.0 g/dL or more increase (53% vs. 36%, p < 0.001), and more achieved correction (Hb >or= 12 g/dL) of anemia (73% vs. 50%, p < 0.001). Patients treated with ferric carboxymaltose compared to those prescribed ferrous sulfate reported greater gains in vitality and physical function and experienced greater improvement in symptoms of fatigue (p < 0.05). There were no serious adverse drug events.


CONCLUSIONS
In patients with iron deficiency anemia due to heavy uterine bleeding, rapid IV administration of large doses of a new iron agent, ferric carboxymaltose, is more effective than oral iron therapy in correcting anemia, replenishing iron stores, and improving quality of life.
Van Wyck
David B
DB
DaVita, Inc, Tucson, Arizona, USA.
Mangione
Antoinette
A
Morrison
John
J
Hadley
Phillip Earl
PE
Jehle
Judi A
JA
Goodnough
Lawrence Tim
LT
D000284:Administration, Oral; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy*; D002118:Calcium / Q000097:blood; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005296:Ferrous Compounds / Q000008:administration & dosage / Q000009:adverse effects; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007275:Injections, Intravenous; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged; D010710:Phosphates / Q000097:blood; D011188:Potassium / Q000097:blood; D011788:Quality of Life; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000188:drug therapy*
D005290:Ferric Compounds; D005296:Ferrous Compounds; D006397:Hematinics; D006454:Hemoglobins; D010710:Phosphates; C020748:ferrous sulfate; C522335:ferric carboxymaltose; D008320:Maltose; D011188:Potassium; D002118:Calcium