Sucrosomial Iron Supplementation in Anemic Patients with Celiac Disease Not Tolerating Oral Ferrous Sulfate: A Prospective Study

Elli, Luca; Ferretti, Francesca; Branchi, Federica; Tomba, Carolina; Lombardo, Vincenza; Scricciolo, Alice; Doneda, Luisa; Roncoroni, Leda

doi:10.3390/nu10030330

Cited by 37 publications

(35 citation statements)

References 23 publications

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“…First, one should consider the possible side effects of supplementation, such as abdominal discomfort, stomach pain, constipation, and diarrhea, which can lead to reduced iron intake. In this regard, it has been reported that some iron formulations such as sucrosomial iron (a ferric pyrophosphate covered by a phospholipid and sucrester membrane) and feralgine (a solution of ferrous bisglycinate chelate and sodium alginate) can be effective in providing iron supplementation in a celiac patient intolerant to iron sulfate, allowing for good intestinal absorption independently of the DMT-1 carrier [13,106,107]. Tea, coffee, calcium, and fiber can also reduce intestinal iron absorption.…”

Section: Discussionmentioning

confidence: 99%

Persistent Iron Deficiency Anemia in Patients with Celiac Disease Despite a Gluten-Free Diet

et al. 2020

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Celiac disease (CD) is an autoimmune disorder characterized by intolerance to dietary gluten in genetically predisposed subjects. Iron deficiency anemia (IDA) is a common sign in CD, being the only abnormality in approximately 40% of celiac patients. A multifactorial etiology leads to IDA in CD. The two main causes are the villous atrophy of the mucosa at the site of iron absorption (the duodenum) and the resulting inflammation, which triggers the mechanism that leads to the anemia of chronic disease. Until now, it has been unclear why some patients with CD continue to have IDA despite a careful gluten-free diet (GFD) and the normalization of villous atrophy. Furthermore, some celiac patients are refractory to oral iron supplementation despite the healing of the mucosa, and they thus require periodic intravenous iron administration. The Marsh classification evaluates the degree of inflammation and villous atrophy, but it does not assess the possible persistence of ultrastructural and molecular alterations in enterocytes. The latter was found in CD in remission after adopting a GFD and could be responsible for the persistently reduced absorption of iron and IDA. Even in non-celiac gluten sensitivity, anemia is present in 18.5–22% of patients and appears to be related to ultrastructural and molecular alterations in intestinal microvilli. It is possible that a genetic component may also play a role in IDA. In this review, we evaluate and discuss the main mechanisms of IDA in CD and the possible causes of its persistence after adopting a GFD, as well as their therapeutic implications.

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Section: Discussionmentioning

confidence: 99%

Persistent Iron Deficiency Anemia in Patients with Celiac Disease Despite a Gluten-Free Diet

et al. 2020

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“…Bioavailability data obtained from animals are interesting, as they indicate that different animals affected by IDA respond to oral SI supplementation in a similar manner and that the efficacy of SI is comparable with all forms of oral iron salts. Remarkably, the efficacy of SI has been demonstrated, not only in animal models of uncomplicated IDA, but also in some clinical conditions, in which the absorption of oral iron is drastically reduced (e.g., celiac disease, post-bariatric surgery, ACI, IRIDA]) [48,49,50,51,52].…”

Section: Sucrosomial® Iron: Preclinical Datamentioning

confidence: 99%

Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation

Gómez‐Ramírez

Brilli²,

Tarantino³

et al. 2018

Pharmaceuticals

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Iron deficiency (ID) is usually treated with oral iron salts, but up to 50% of patients complain of gastrointestinal side effects, leading to reduced compliance with treatment. Intravenous (IV) iron formulations are increasingly safe, but there is still a risk of infusion, hypersensitivity reactions and the need for venous access and infusion monitoring. Sucrosomial® Iron (SI) is an innovative oral iron formulation in which ferric pyrophosphate is protected by a phospholipid bilayer plus a sucrester matrix (sucrosome), which is absorbed through para-cellular and trans-cellular routes (M cells). This confers SI’s unique structural, physicochemical and pharmacokinetic characteristics, together with its high iron bioavailability and excellent gastrointestinal tolerance. The analysis of the available evidence supports oral SI iron as a valid option for ID treatment, which is more efficacious and tolerable than oral iron salts. SI has also demonstrated a similar effectiveness, with lower risks, in patients usually receiving IV iron (e.g., chronic kidney disease, cancer, bariatric surgery). Thus, oral SI emerges as a valuable first option for treating ID, especially for subjects with intolerance to iron salts or those for whom iron salts are inefficacious. Moreover, SI should also be considered as an alternative to IV iron for initial and/or maintenance treatment in different patient populations.

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“…Sucrosomial iron (Sideral® Forte), a preparation of ferric pyrophosphate conveyed within a phospholipid and sucrose esters of fatty acid membrane, is a new generation of oral iron, which shows a high intestinal absorption and high bioavailability with a low incidence of side effects, due to lack of any direct contact with intestinal mucosa [8][9][10]. In comparison with the other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy of iron replacement in several kinds of patients [11][12][13], and in particular in ND-CKD patients [8].…”

Section: Introductionmentioning

confidence: 99%

Oral Sucrosomial® iron versus intravenous iron for recovering iron deficiency anaemia in ND-CKD patients: a cost- minimization analysis

Riccio

Sabbatini²,

Capuano³

et al. 2020

BMC Nephrol

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Background: Oral iron is recommended as first line treatment of anemia in non-dialysis chronic kidney disease (ND-CKD) patients. Sucrosomial® iron, a new generation oral iron with high absorption and bioavailability and a low incidence of side effects, has shown to be not inferior to intravenous (IV) iron in the replacement of iron deficiency anemia in patients with ND-CKD. Besides the clinical benefit, it is also important to determine the comparative total costs of oral versus IV iron administrations. The aim of this study was to perform a cost-minimization analysis of oral Sucrosomial iron, compared with IV iron gluconate from an Italian societal perspective. Methods: Cost analysis was performed on the 99 patients with ND-CKD and iron-deficiency anemia of the randomized trial by Pisani et al. Human and material resources utilization was recorded during each iron administration. According to study perspective, direct and indirect costs were considered. Costs for each resource unit were taken from official Italian sources. Probabilistic sensitivity analyses were carried out to test the robustness of the results. Results: The base case analysis showed an average cost/cycle per patient of € 111 for oral iron and € 1302 for IV iron. Thus, the potential saving was equal to € 1191 per patient/cycle. The sensitivity analysis showed that the most sensitive driver is the time loss by patient and caregivers for the therapy and related-care, followed by the minutes of nursing care and the number of kilometres travelled to reach the referral centre. Discussion: This study showed that oral Sucrosomial® iron could offer specific advantages in terms of potential savings, and allowed identifying some implications for future research. Such advantages still persist with the new single dose IV iron formulation available in the market, although to a lesser extent.

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Sucrosomial Iron Supplementation in Anemic Patients with Celiac Disease Not Tolerating Oral Ferrous Sulfate: A Prospective Study

Cited by 37 publications

References 23 publications

Persistent Iron Deficiency Anemia in Patients with Celiac Disease Despite a Gluten-Free Diet

Persistent Iron Deficiency Anemia in Patients with Celiac Disease Despite a Gluten-Free Diet

Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation

Oral Sucrosomial® iron versus intravenous iron for recovering iron deficiency anaemia in ND-CKD patients: a cost- minimization analysis

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