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Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial.

AbstractBACKGROUND:
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.
STUDY DESIGN AND 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.
AuthorsDavid B Van Wyck, Antoinette Mangione, John Morrison, Phillip Earl Hadley, Judi A Jehle, Lawrence Tim Goodnough
JournalTransfusion (Transfusion) Vol. 49 Issue 12 Pg. 2719-28 (Dec 2009) ISSN: 1537-2995 [Electronic] United States
PMID19682342 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Ferric Compounds
  • Ferrous Compounds
  • Hematinics
  • Hemoglobins
  • Phosphates
  • ferrous sulfate
  • ferric carboxymaltose
  • Maltose
  • Potassium
  • Calcium
Topics
  • Administration, Oral
  • Adult
  • Anemia, Iron-Deficiency (drug therapy)
  • Calcium (blood)
  • Female
  • Ferric Compounds (administration & dosage, adverse effects)
  • Ferrous Compounds (administration & dosage, adverse effects)
  • Hematinics (administration & dosage, adverse effects)
  • Hemoglobins (metabolism)
  • Humans
  • Injections, Intravenous
  • Maltose (administration & dosage, adverse effects, analogs & derivatives)
  • Middle Aged
  • Phosphates (blood)
  • Potassium (blood)
  • Quality of Life
  • Treatment Outcome
  • Uterine Hemorrhage (drug therapy)

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