Oral high-dose sucrosomial iron vs intravenous iron in sideropenic anemia patients intolerant/refractory to iron sulfate

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ORIGINAL ARTICLE

Oral high-dose sucrosomial iron vs intravenous iron in sideropenic anemia patients intolerant/refractory to iron sulfate: a multicentric randomized study Giulio Giordano 1 & Mariasanta Napolitano 2

&

Valeria Di Battista 3 & Alessandro Lucchesi 3

Received: 4 October 2020 / Accepted: 23 November 2020 # The Author(s) 2020

Abstract Iron deficiency anemia is among the most frequent causes of disability. Intravenous iron is the quickest way to correct iron deficiency, bypassing the bottleneck of iron intestinal absorption, the only true mechanism of iron balance regulation in human body. Intravenous iron administration is suggested in patients who are refractory/intolerant to oral iron sulfate. However, the intravenous way of iron administration requires several precautions; as the in-hospital administration requires a resuscitation service, as imposed in Europe by the European Medicine Agency, it is very expensive and negatively affects patient’s perceived quality of life. A new oral iron formulation, Sucrosomial iron, bypassing the normal way of absorption, seems to be cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations. In this multicentric randomized study, we analyze the cost-effectiveness of intravenous sodium ferrigluconate vs oral Sucrosomial iron in patients with iron deficiency anemia refractory/intolerant to oral iron sulfate without other interfering factors on iron absorption. Keywords Iron deficiency anemia . Intravenous sodium ferrigluconate . Oral Sucrosomial iron . High doses . Refractoriness/ intolerance to oral iron sulfate

Introduction Iron deficiency anemia (IDA) is among the five most frequent causes of disability in humans [1]. Anemia affects one-third of the world population and IDA is the first cause, regarding 1.24 billion of individuals [1, 2]. WHO estimates that 50% of anemia cases worldwide are due to IDA [3] and prevalence of iron deficiency anemia in Europe was estimated about 20% [4, 5].

Giulio Giordano and Mariasanta Napolitano equally contributed to the current study. * Mariasanta Napolitano [email protected] 1

Division of Internal Medicine, Hematology Service, Regional Hospital “A. Cardarelli”, Campobasso, Italy

2

Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), Haematology Unit, University Hospital “P. Giaccone”, University of Palermo, Via del Vespro 127, 90127 Palermo, Italy

3

Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

Iron deficiency (ID) manifests in two forms: absolute or functional. The first one is due to a total body iron stores lack. The second one is present in diseases in which total body iron stores are normal or increased, but iron supply to the bone marrow is inadequate because of reduced iron bioavailability, as in many acute and chronic inflammatory diseases. Absolute and functional iron deficiencies can coexist [6]. Sucrosom