A multicenter, randomized, active‐controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia

Onken, Jane E.; Bregman, David B.; Harrington, Robert A.; Morris, David; Ács, Péter; Akright, Bruce; Barish, Charles F.; Bhaskar, Birbal S.; Smith‐Nguyen, Gioi N.; Butcher, Angelia; Koch, Todd A.; Goodnough, Lawrence T.

doi:10.1111/trf.12289

Cited by 135 publications

(137 citation statements)

References 15 publications

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“…Trial 2 was designed to evaluate FCM in subjects with IDA of any etiology who did not demonstrate a 1 g/dl increase in Hgb after the 14-day oral iron run-in period (with documented oral iron compliance ≥67%) [Onken et al 2013a]. It also provided the opportunity to test whether baseline hepcidin level could be used to prospectively identify subjects unlikely to respond adequately to oral iron ].…”

Section: Transient Reductions In Blood Phosphate Levelsmentioning

confidence: 99%

Experience with intravenous ferric carboxymaltose in patients with iron deficiency anemia

Bregman

Goodnough

2014

Therapeutic Advances in Hematology

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Erythropoiesis may be limited by absolute or functional iron deficiency or when chronic inflammatory conditions lead to iron sequestration. Intravenous iron may be indicated when oral iron cannot address the deficiency. Ferric carboxymaltose (FCM) is a nondextran iron preparation recently approved in the United States for intravenous treatment of iron deficiency anemia (IDA) in adult patients with intolerance or unsatisfactory response to oral iron or with nondialysis-dependent chronic kidney disease. The full dose is two administrations of up to 750 mg separated by at least 7 days (up to 1500 mg total). FCM can be injected in 7-8 min or diluted in saline for slower infusion. The efficacy and safety of this dose was established in two prospective trials that randomized over 3500 subjects, 1775 of whom received FCM. One trial showed similar efficacy of FCM to an approved intravenous iron regimen (1000 mg of iron sucrose) in 2500 subjects with chronic kidney disease and additional cardiovascular risk factors. The other trial showed superior efficacy of FCM to oral iron in subjects with IDA due to various etiologies (e.g. gastrointestinal or uterine bleeding). In these trials, there was no significant difference between FCM and comparator with respect to an independently adjudicated composite safety endpoint, including death, myocardial infarction, or stroke. A database of 5799 subjects exposed to FCM provided a safety profile acceptable for regulatory approval. Mechanistic studies demonstrated that the transient, asymptomatic reduction in serum phosphate observed following FCM administration results from induction of fibroblast growth factor 23, which in turn induces renal phosphate excretion. An elevated hepcidin level may identify patients with IDA who will not respond to oral iron but will respond to FCM. The ability to administer FCM in two rapid injections or infusions will likely be viewed favorably by patients and healthcare providers.

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Section: Transient Reductions In Blood Phosphate Levelsmentioning

confidence: 99%

Experience with intravenous ferric carboxymaltose in patients with iron deficiency anemia

Bregman

Goodnough

2014

Therapeutic Advances in Hematology

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“…The intravenous formulations of iron are more effective and correct anemia more rapidly than oral preparations as they circumvent the problem of iron absorption in the gut [Macdougall et al 2014;Onken et al 2014;Vadhan-Raj et al 2014]. It also overcomes the problem of low adherence associated with oral therapy [Bayraktar and Bayraktar, 2010].…”

Section: Intravenous Iron Replacementmentioning

confidence: 99%

The role of ferric carboxymaltose in the treatment of iron deficiency anemia in patients with gastrointestinal disease

Koduru

Abraham

2015

Therap Adv Gastroenterol

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Iron deficiency anemia (IDA) is the most common form of nutritional anemia worldwide. Iron plays a pivotal role in vital functioning of almost every organ system. IDA affects both physical and psychological functioning of humans. Oral iron is considered as first-line therapy for the treatment of IDA due to low cost, good safety profile and ease of administration. However, the absorption of oral iron is affected by several factors and incidence of gastrointestinal side effects can lead to lack of adherence to therapy as well as poor efficacy. This has led to the emergence of intravenous iron therapy which is clearly superior to oral iron with higher increment of hemoglobin levels and rapid replenishment of iron stores. Ferric carboxymaltose (FCM) is a novel non-dextran intravenous iron form which has been approved for use in patients with iron deficiency who have had inadequate response to oral iron therapy, intolerance to oral iron, or nondialysis-dependent chronic kidney disease. The safety and efficacy of using FCM for the treatment of IDA has been demonstrated in several clinical trials. One dose can provide a large amount of iron and has a very short infusion time. It should be considered as first-line therapy in patients with active inflammation like inflammatory bowel disease when gastrointestinal absorption of oral iron may be compromised. It should also be given to patients who have inadequate response to oral iron therapy. It has been shown to be noninferior to other intravenous iron formulations with a good safety profile and produced fewer anaphylactic reactions.

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“…Они более эффективны, безопасны и хорошо переносятся как для коррекции ЖДА, так и для поддержания запасов железа [26,27]. Основными препа-ратами железа для внутривенного введения считаются железа сахарат, железа карбоксимальтозат, железа гидрок-сид декстран, железа изомальтозат [28].…”

Section: лечение анемииunclassified

“…нормализация гемоглобина наблюдалась у 72,8% паци-ентов при введении максимум 3 инфузий по 1000 или 500 мг железа против 61,8% при введении 11 инфузий по 200 мг железа [27].…”

Section: при отсутствии клинических эндоскопических или биохимическиunclassified

Features of the anemia at patients with Crohn’s disease

Ахмедов¹,

Иванюк²,

Бикбавова³

et al. 2018

Med. sov.

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A multicenter, randomized, active‐controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia

Abstract: Two 750-mg FCM infusions are safe and superior to oral iron in increasing Hb levels in IDA patients with inadequate oral iron response.

Cited by 135 publications

References 15 publications

Experience with intravenous ferric carboxymaltose in patients with iron deficiency anemia

Experience with intravenous ferric carboxymaltose in patients with iron deficiency anemia

The role of ferric carboxymaltose in the treatment of iron deficiency anemia in patients with gastrointestinal disease

Features of the anemia at patients with Crohn’s disease

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