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Asperti, Michela, Magdalena Gryzik, Elisa Brilli, Annalisa Castagna, Michela Corbella, Rossella Gottardo, Domenico Girelli, Germano Tarantino, Paolo Arosio, and Maura Poli. "Sucrosomial® Iron Supplementation in Mice: Effects on Blood Parameters, Hepcidin, and Inflammation." Nutrients 10, no. 10 (September 21, 2018): 1349. http://dx.doi.org/10.3390/nu10101349.
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Sucrosomial® Iron is a recently developed formulation to treat iron deficiency based on ferric pyrophosphate covered by a matrix of phospholipids plus sucrose esters of fatty acids. Previous data indicated that Sucrosomial® Iron is efficiently absorbed by iron-deficient subjects, even at low dosage, and without side effects. Its structural properties may suggest that it is absorbed by an intestinal pathway which is different to the one used by ionic iron. Although, studies in vitro showed that Sucrosomial® Iron is readily absorbed, no animal models have been established to study this important aspect. To this aim, we induced iron deficient anemia in mice by feeding them with a low-iron diet, and then we treated them with either Sucrosomial® Iron or sulfate iron by gavage for up to two weeks. Both iron formulations corrected anemia and restored iron stores in a two-week period, but with different kinetics. Ferrous Sulfate was more efficient during the first week and Sucrosomial® Iron in the second week. Of note, when given at the same concentrations, Ferrous Sulfate induced the expression of hepcidin and four different inflammatory markers (Socs3, Saa1, IL6 and CRP), while Sucrosomial® Iron did not. We conclude that anemic mice are interesting models to study the absorption of oral iron, and that Sucrosomial® Iron is to be preferred over Ferrous Sulfate because of similar absorption but without inducing an inflammatory response.
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Brilli, Elisa, Maura Poli, Asperti Michela, Giulio Giordano, Elena Pera, Francesco Equitani, and Germano Tarantino. "Effects of Sucrosomial® iron in Pre-Clinical and Clinical Conditions of Inflammation." Blood 130, Suppl_1 (December 7, 2017): 942. http://dx.doi.org/10.1182/blood.v130.suppl_1.942.942.
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Abstract Introduction: Proteins such as Ferritin (Ft), Hemoglobin (Hb) and Transferrin Receptor (TfR1) are involved in tissue iron distribution while systemiciron metabolism is regulated by Hepcidin. Interleukin-6 (IL-6) release is induced in response to an inflammatory status and enhances Hepcidin expression, as consequence, dietary iron absorption and macrophage iron recycling are inhibited. Anemia of Chronic Disease (ACD) is a form of anemia associated with many different chronic disorders. It is characterized by high hepcidin and CRP or IL-6 expression and low serum iron transferrin concentration while ferritin can be normal or elevated. Oral iron delivery is especially attractive thanks to the ease of administration, but commonly used iron salts are poorly absorbed and ineffective to increase Hb concentration in particular in patients with ACD. We have developed an oral Iron formulation named Sucrosomial® Iron, preparation of ferric pyrophosphate, covered by a phospholipids plus sucrester matrix, with high bioavailability and tolerability, which promotes ferric iron absorption thanks to gastro-resistant and matrix composition properties and showed Hb concentration improvement not inferior to intravenous iron. Objective: to showpre-clinical and clinical evidences of absorption, effectiveness and tolerability of Sucrosomial Iron using in vivo and in vitro models and in patients with ACD too. Methods: To study the effects of oral supplementation on Iron metabolism and inflammatory status, Hb, Ft, TfR1, Socs3 and Hepcidin expression were analyzed. We have supplemented wild-type (wt) and iron deficient (ID) mice, maintained in iron-free diet for 8 weeks, with 1mg/kg/die of Sucrosomial® Iron or Iron Sulfate or Placebo by oral gavage, for 2 weeks. The role of Sucrosomial® Iron on the inflammatory response, was studied in LPS induced HepG2 hepatoma cells. Cells were treated with Sucrosomial® Iron and the levels of hepcidin were assessed 6, 18 and 24 hours after treatment. To show the efficacy and compliance of Sucrosomial® Iron a multi-centric randomized study on 300 patients with ACD were performed. Patients were supplemented with iron sulfate (65 mg o.i.d.), microencapsulated iron, micronized iron, Sucrosomial® Iron, heminic-chelated bisglycinated and iron chelated bisglycinated iron (30 mg t.i.d.). Median Hb value at the beginning was 8.2 g/dl. In group of patients with high CRP value median Hb value was 7.8 g/dl. Results: In mice treated with Sucrosomial® Iron, Hb level mean increase was 4,9 g/dl while TSAT value is not significantly higher than animals treated with Sulfate Iron. Furthermore mice treated with Sucrosomial® Iron showed a preferential accumulation of iron in spleen. Hepcidin and Socs3 mRNA expression was not induced during Sucrosomial® Iron treatment while was up-regulated in mice treated with Iron Sulfate (Figure 1). In vitro experiments on HepG2 LPS-induced cells displayed that treatment with Sucrosomial Iron® is able to reduce hepcidin concentration at different time points (Figure 2). Data from the clinical study showed that Sucrosomial® Iron is well tolerate and effective ACD patients. Only patients treated with Sucrosomial® Iron showed constant increase in Hb concentration over time. In all groups Hb level achieves a plateau phase after three months and ferritin level starts to increase. At three months higher levels of Hb are present in Sucrosomial® Iron (13.2 g/dl), heminic chelated bisglycinated iron (11.7 g/dl), chelated bisglycinated iron (11.3 g/dl) treated patients. In patients with high CRP level (>30 ng/ml) only those receiving Sucrosomial® Iron showed Hb increase from the tenth week and this continue up to the sixth month (Hb 12.5 g/dl) and seems to be correlated to a significantly decrease of CRP (5 mg/L) (Figure 3). Side effects are higher in ferrous sulfate (15/50) and sunactive treated groups (6/60). Conclusions: In summary, results showed that Sucrosomial® Iron treatment could regulate iron homeostasis through an increase in Hb concentration and better tolerability during inflammatory status. These evidences may suggest that this new oral iron formulation behaves differently than other oral iron salts, perhaps due to different absorption pathways. Besides we have observed a decrease in CRP and Hepcidin concentration, these results should be further investigate. Disclosures Brilli: Pharmanutra S.p.A.: Consultancy. Pera: Pharmanutra S.p.A.: Employment. Tarantino: Pharmanutra S.p.A.: Employment.
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Brilli, Elisa, Michela Asperti, Annalisa Castagna, Claudio Cerchione, Domenico Girelli, Maura Poli, and Germano Tarantino. "Effect of Oral Iron Treatment in Tmprss6 Knock-out Mouse Model." Blood 134, Supplement_1 (November 13, 2019): 2235. http://dx.doi.org/10.1182/blood-2019-122416.
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Introduction: Iron Refractory Iron Deficiency Anemia (IRIDA) is an autosomal recessive iron metabolism disorder caused by mutations in Tmprss6 gene which encodes for Matriptase2 (MT2) that, by activating hemojuvelin (HJV), regulates the production of hepcidin, the master iron regulatory hormone. Altered MT2 cannot suppress hepatic BMP6/SMAD signaling in low iron condition, hence the resulting hepcidin excess blocks dietary iron absorption and cells release, leading to a form of iron deficiency that is typically refractory to oral iron supplementation. IRIDA is characterized by moderate/severe microcytic anemia (Hemoglobin 6-9 g/dL; MCV 45-65 fL); low transferrin saturation (<5%); impaired oral iron absorption and only a transient response to parenteral iron. Nonetheless, the current treatment is mainly based on parenteral iron therapy. A case study on a child with IRIDA showed for the first time the ability of Sucrosomial® Iron, to increase hemoglobin and MCV values over time (Capra et al., 2017). This oral iron formulation is an innovative preparation of ferric pyrophosphate, covered by a phospholipids plus sucrester matrix, with gastro-resistance properties, high bioavailability and tolerability due to alternative absorption pathways as endocytosis and M cells mediated route (Gomez-Ramirez et al., 2018). Moreover, Sucrosomial® Iron has been successfully used to treat iron deficiency in various clinical conditions, including inflammatory bowel diseases (Abbati et al., 2019). To confirm and characterize the ability of Sucrosomial® Iron to increase Hb in IRIDA disease we studied the response to Sucrosomial® Iron in a IRIDA mouse model (Mask) comparing the efficacy of Sucrosomial® Iron and Sulfate Iron at two different doses and in chronic treatment. Aim: to study Sucrosomial® Iron effect in IRIDA using the Tmprss6 knock-out mouse model Material and Methods: m/m homozygous mice (9-weeks old male mice, four mice per experimental group) were kept at iron balance diet and treated with 0.5 or 4 mg/Kg of Ferrous sulfate, Sucrosomial® Iron (patent n° PCT/IB2013/001659 owned by Alesco s.r.l, Italy), or vehicle by gavage for 35 days. Four 9-weeks old m/- male mice per experimental group were daily treated and Hb and Ht were monitored weekly. Mice were sacrificed at the end of treatments; blood, and different organs were collected for analysis. Total RNA was isolated from tissues using TRIzol Reagent (Ambion), cDNA was generated by Reverse transcription (Promega, Milan, Italy) and samples were analyzed for Hepcidin and Socs3 mRNA levels by qRT-PCR using PowerUp SYBR Green Master Mix (Life Technologies). Results: we analyzed the iron status of anemic homozygous Mask mice from 3 to 35 weeks of age by studying serological and tissue iron content. Interestingly only Sucrosomial® Iron (not Ferrous Sulfate), increased hemoglobin level from 11-12 to 13-14 g/dL in the first week with a tendency to increase until the fourth week, when it stabilized at 13 g/dL (Figure 1A-B). Serum iron concentration was higher in the Sucrosomial® Iron treated animals than in those treated with vehicle, while was lower in the Ferrous sulfate treated animals. Similar pattern was observed for spleen iron content that increased in mice treated with Sucrosomial® Iron but not in those receiving Ferrous sulfate. Liver iron concentration did not apparently varied after the treatments, but duodenal iron increased significantly only in the mice treated with the higher dose of Ferrous sulfate (Figure 1 C-F). Interestingly, we found that the mice treated with both doses of Ferrous sulfate, but not those treated with Sucrosomial® Iron, had a higher mRNA levels of hepcidin and of the inflammatory marker Socs3 (Figure 1 G-H). Conclusion: this study showed for the first time that Sucrosomial® Iron is able to increase hemoglobin level in a mouse model of IRIDA, probably due to its alternative absorption pathway. Sucrosomial® Iron could be used as effective iron supplement to improve iron status in IRIDA patients. Disclosures Girelli: La Jolla Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy; Vifor Pharma: Other: honoraria for lectures; Silence Therapeutics: Membership on an entity's Board of Directors or advisory committees.
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Giordano, Giulio, Marco Alfio Cutuli, Alessandro Lucchesi, Irene Magnifico, Noemi Venditti, Franca Vergalito, Maurizio Gasperi, and Roberto Di Marco. "Iron Support in Erythropoietin Treatment in Myelodysplastic Syndrome Patients Affected by Low-Risk Refractory Anaemia: Real-Life Evidence from an Italian Setting." Acta Haematologica 143, no. 2 (September 18, 2019): 155–62. http://dx.doi.org/10.1159/000501329.
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Refractory anaemia (RA) among myelodysplastic syndrome (MDS) is associated with a partial functional iron deficit and may require transfusions. In low-risk lymphoma and solid tumour patients, iron support improves erythropoietin (EPO) cost-effectiveness in treating anaemia. The aim of this study is to see if oral sucrosomial iron support improves the cost-effectiveness of EPO treatment in MDS patients affected by low-risk RA. We treated patients with EPO only or with EPO plus oral sucrosomial iron or intravenous (i.v.) iron. The need for transfusions was lowest in the group taking oral iron (p = 0.016) or not receiving supplementation at all (p = 0.022). We compared costs of EPO with i.v. ferric gluconate or oral sucrosomial iron supplementation or no iron supplementation. The oral iron group had fewer side effects, fewer patient medical visits in the out-patient setting, and fewer transfusions; this led to higher savings on direct hospital costs and indirect patient costs (lost days at work) and translated into a 50% abatement of overall expenditures. EPO treatment-related expenditures in MDS-RA patients were lowest with oral sucrosomial iron supplementation (Sideral®), with a longer interval between EPO administration in maintenance treatment, quicker hemoglobin recovery, lower ferritin increase and fewer blood transfusions.
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Zakrzewski, Martha, Sarah J. Wilkins, Sheridan L. Helman, Elisa Brilli, Germano Tarantino, Gregory J. Anderson, and David M. Frazer. "Supplementation with Sucrosomial® iron leads to favourable changes in the intestinal microbiome when compared to ferrous sulfate in mice." BioMetals 35, no. 1 (October 25, 2021): 27–38. http://dx.doi.org/10.1007/s10534-021-00348-3.
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AbstractIron deficiency is one of the most common nutritional deficiencies worldwide and is often treated with oral iron supplements. However, commonly used supplements, including those based on ferrous iron salts, are associated with gastrointestinal side effects and unfavorable changes in the intestinal microbiome. Sucrosomial® iron is a novel iron formulation that is effective at treating iron deficiency, and with fewer gastrointestinal side effects, yet its effect on the gut microbiome has not been examined previously. Thus, we treated mice for two weeks with diets containing either Sucrosomial® iron or ferrous sulfate as the sole iron source and examined bacterial communities in the intestine using 16S Microbial Profiling of DNA extracted from feces collected both prior to and following dietary treatment. Mice treated with Sucrosomial® iron showed an increase in Shannon diversity over the course of the study. This was associated with a decrease in the abundance of the phylum Proteobacteria, which contains many pathogenic species, and an increase in short chain fatty acid producing bacteria such as Lachnospiraceae, Oscillibacter and Faecalibaculum. None of these changes were observed in mice treated with ferrous sulfate. These results suggest that Sucrosomial® iron may have a beneficial effect on the intestinal microbiome when compared to ferrous sulfate and that this form of iron is a promising alternative to ferrous iron salts for the treatment of iron deficiency.
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Tarantino, Germano, Elisa Brilli, Giulio Giordano, Alessandro Torelli, and Francesco Equitani. "Innovative Oral Iron Supplement (Sucrosomial Iron®) Is Able to Downregulate Hepcidin Release during Inflammation: In Vitro Study." Blood 126, no. 23 (December 3, 2015): 4563. http://dx.doi.org/10.1182/blood.v126.23.4563.4563.
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Abstract Introduction: the involvement of iron in a wide range of metabolic processes make it one of the essential elements for living organisms (Inamura et al., 2005). Anemia of chronic disease (ACD), also termed anemia of chronic inflammation, is the most prevalent anemia in subjects suffering from chronic diseases such as cancer and Chronic Kidney Disease (CKD). A central mechanism by which chronic disease causes anemia is the retention of iron in the reticuloendothelial system, causing a functional iron deficiency and consequently an insufficient iron supply for erythropoiesis. Hepcidin is a primarily liver-derived peptide that orchestrates body iron homeostasis and its expression increases in response to elevated iron stores, inflammation and ER stress (Maliken et al. 2011). In those conditions produced Hepcidin bind to the cellular iron exporter, Ferroportin (Fp1), resulting in Fp1 internalization and degradation with subsequent reduction of cellular iron release (Theurl et al., 2014). Some studies showed that pharmacological inhibition of Hepcidin could reverse cellular iron retetion and improve anemia in different models of inflammatory anemia (Steinbicker et al., 2011, Theurl et al., 2011). Moreover recent scientific publications suggest also a role of other dietary supplements in regulating Hepcidin, reducing its concentration and thus increasing circulating iron in blood (Zughaier et al. 2014). Sucrosomial Iron¨ (Sideral¨) is a new and still unique preparation of ferric pyrophosphate, useful for treatment of iron deficiency related anemia. Aim: we have previously performed a clinical study in which we showed that Sucrosomial iron is able to increase Hemoglobin level in CKD patients (Pisani et al., 2014). On the basis of these results we have investigated the role of Sucrosomial Iron¨ in inflammation process. In particular, we studied the capability of Sucrosomial Iron¨ to reduce Hepcidin release in LPS -induced inflammation made in the hepatoma cell line (HepG2). Results: Cells were incubated with LPS, treated with Sucrosomial Iron¨ and then analyzed for Hepcidin production in terms of protein expression at 6 and 24h after treatment with Sucrosomial Iron¨. Results showed that Sucrosomial Iron¨ is able to significantly reduce Hepcidin level both 6 and 24 h after sucrosome treatment compare to others iron formulations (Figure 1A-B). Materilas and Methods: Sucrosomial Iron¨ preparation of ferric pyrophosphate convered by a; LPS: Lipopolysaccharides from Escherichia coli (Sigma-Aldrich); Empty matrix preparation of phospholipids plus sucrose esters of fatty acids. Conclusions: This evidence should be considered as a preliminary investigation on the effect of Sucrosomial Iron¨ on the production of Hepcidin during chronic inflammation. Bibliography Inamura J et al. Upregulation of hepcidin by interleukin-1 in human hepatoma cell lines. Hepatology Research 33 2005 198-205. Maliken BD et al., The Hepcidin Circuits Act: Balancing Iron and Inflammation, Hepatology. 2011 May ; 53(5): 1764-1766; Theurl M et al. Hepcidin as a predictive factor and therapeutic target in erythropoiesis- stimulating agent treatment for anemia of chronic disease in rats Haematologica. 2014 Sep;99(9):1516-24. Epub 2014 Jun 3. Theurl et al. Pharmacologic inhibition of hepcidin expression reverses anemia of chronic inflammation in rats. Blood. 2011;118(18): 4977-84. Steinbicker AU et al. Inhibition of bone morphogenetic protein signaling attenuates anemia associated with inflammation Blood. 2011 May 5;117(18):4915-23. doi: 10.1182/blood-2010-10-313064. Epub 2011 Mar 10. Zughaier SM et al. The role of vitamin D in regulating the iron-hepcidin-ferroportin axis in monocytes. J Clin Transl Endocrinol. 2014 Mar 21;1(1):19-25. Pisani et al. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. Epub 2014 Nov 13. Figure 1. This graph shows the level of Hepcidin produced by LPS treated HepG2 cells 6 hours after treatment with iron compounds. Figure 1. This graph shows the level of Hepcidin produced by LPS treated HepG2 cells 6 hours after treatment with iron compounds. Figure 2. This graph shows the level of Hepcidin produced by LPS- treated HepG2 cells 24 hours after treatment with iron compounds. Figure 2. This graph shows the level of Hepcidin produced by LPS- treated HepG2 cells 24 hours after treatment with iron compounds. Disclosures Tarantino: Pharmanutra s.p.a.: Employment. Brilli:Pharmanutra s.p.a.: Employment.
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Brilli, Elisa, Alessandra Romano, Angela Fabiano, Ylenia Zambito, Francesco Di Raimondo, and Germano Tarantino. "Sucrosomial Technology Is Able to Promote Ferric Iron Absorption: Pre-Clinical and Clinical Evidences." Blood 128, no. 22 (December 2, 2016): 3618. http://dx.doi.org/10.1182/blood.v128.22.3618.3618.
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Abstract Introduction: Oral iron delivery is attractive due to the ease of administration and is mainly based on immediate release formulations of ferrous iron. Commonly used ferrous iron salts are poorly absorbed. Overcoming gastrointestinal barriers, is a great challenge and there is a need for new absorption and protective enhancers. Iron DeficiencyAnemia (IDA) is a presenting symptom in approximately 40% of patients with Hodgkin's Lymphoma (HL). Usually with hemoglobin (Hb) between 10 and 12 g/dL. When considering oral iron therapy in cancer patients one must take into account the impact of worsening of existing clinical conditions due to oral iron as intolerance and non-compliance. For these reasons, effective management of iron deficiency anemia is mandatory and iron supplementation is often necessary. To avoid constant exposure of intestinal cells to insoluble iron and consequent side effects, we have developed a new oral Iron formulation named Sucrosomial¨ Iron. This oral formulation is an innovative preparation of ferric pyrophosphate, covered by a phospholipids plus sucrester matrix, with high bioavailability and tolerability and has been showed to improve Hb concentration similarly to intravenous iron but without any gastrointestinal side effects. Objective: to showpre-clinical and clinical evidences of the absorption, effectiveness and tolerability of Sucrosomial¨ Iron. Methods: to study the absorption pathway of Sucrosomial¨ Iron, gastro-resistance and permeation experiments have been performed using in vitro simulated gastric pH digestion, and isolate rat intestine ex vivo models, respectively. To show the efficacy and compliance of Sucrosomial¨ Iron (Sideral¨ Forte) in IDA patients with Hodgkin's Lymphoma (HL), 25 patients were retrospective analyzed, (median age, 35 years; range 26 to 44 years). All patients were staged 2B or higher, according to Ann Arbor classification, none of them showed bone marrow infiltration. A continued treatment with oral Sideral¨ Forte (30 mg/die) was performed for the whole period of chemotherapy administration and iron parameters were tested at the end of the planned treatment. Results: In vitro gastro-resistance experiment displays the ability of Sucrosomial¨ Iron (SRM), to avoid release of Ferric Iron from the matrix compared to phospholipid only-containing iron formulation (PCC, Figure 1). These results showed the gastro-resistance features of SRM.We have performed ex-vivo permeability experiments using Hussing chamber-like experimental model and measured ferric iron concentration in presence of bivalent iron chelator (BPDS) too. Thanks to this model we have showed that SRM is able to cross the intestinal tissue through a passive transport in respect to the other iron formulations (Figure 2). Moreover we have observed that Sucrosome components ratio is pivotal for kinetics properties of Sucrosomial¨ Iron. Data from the clinical study showed that Sideral¨ Forte is well tolerated and effective in patients with HL in advanced stage. At baseline (T0) medium Hb level was 10.2 g/dL, median serum iron and total iron-binding capacity (TIBC) were 35 μg/dL and 244 μg/dL respectively. Ferritin levels showed a wide variation with a median of 90 ng/mL. At the end of treatment (T1 6 months) medium Hb level was 12.8 g/dL (+2,2 g/dL) the median serum iron and total iron-binding capacity increased up to 95 μg/dL and 264 μg/dL and Ferritn levels increased with a median of 277 ng/mL (Figure 3). Thanks to the high compliance and tolerability, all patients were able to continue Sucrosomial¨ Iron supplementation up to the end of the chemioterapy period. CONCLUSIONS: these results showed that Sucrosomial technology is able to protect ferric iron from the gastric pH conferring the ability to reach covered the intestine for absorption and to cross intestinal epithelium through a passive route; thus minimizing the conventional oral iron side effects and increasing Hb and Ferritin levels in HL patients. SRM Iron pyrophosphate, Lecithin, Sucrester PCC phospholipid-containing carrier BPDS Bivalent Iron chelator PYR Iron pyrophosphate SLP pyr, Lecithin, low phospholipid concentration, Sucrester SRMS pyr, Lecithin, high Sucrester concentration Results are expressed as median values *p<0,05 Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Brilli: Pharmanutra S.p.A.: Employment. Tarantino:Pharmanutra S.p.A.: Employment.
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Tarantino, Germano, Elisa Brilli, Ylenia Zambito, Giulio Giordano, and Francesco Equitani. "Sucrosomial Iron®: A New Highly Bioavaible Oral Iron Supplement." Blood 126, no. 23 (December 3, 2015): 4561. http://dx.doi.org/10.1182/blood.v126.23.4561.4561.
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Abstract Introduction: Iron deficiency is one of the most widespread nutritional deficiencies. Globally two billion people are suffering from iron- deficiency anemia (Hermida et al., 2010). Oral therapy for iron deficiency is mainly based on immediate release formulations of ferrous iron. However, modified formulations have been marketed to reduce gastrointestinal side effects and to prevent iron instability in the gastrointestinal tract. Overcoming biological barriers, including the gastrointestinal epithelial barriers, is a great challenge for pharmaceutical research and thus there is a need for new absorption enhancers with more favorable profile. Sucrose esters are widely used in the food industry, and there are reports on their potential use in pharmaceutical formulations as excipients (Szuts A et al., 2008). In vitro methods using cell cultures have been proposed to assess iron bioavailability as an alternative to in vivo methods. Caco-2 cells have shown numerous morphological and biochemical characteristics of enterocytes and have been successfully used to study iron absorption (Garcia et al., 1996; Jovani et al., 2001). Caco-2 monolayers formed a good barrier as reflected by high transepithelial resistance and positive immunostaining for junctional proteins. Sucrose esters in nontoxic concentrations significantly reduced resistance and impedance, and increased permeability of some components in Caco-2 monolayers. Recent data indicate that sucrose esters can enhance drug permeability through both the transcellular and paracellular routes (Kiss et al., 2014). Aim: The strong correlation between the published human absorption data and the iron uptake by Caco-2 cells makes them an ideal in vitro model to study iron bioavailability (Au and Reddy, 2000). For this, in the present study, we compared the bioavailability of innovative Oral Iron formulation based on Sucrosomial Iron¨ (Sideral¨) with three different Iron formulations (Figure 1). Materials and Methods: Sucrosomial Iron, preparation of ferric pyrophosphate convered by a phospholipids plus sucrose esters of fatty acids matrix; Lipofer¨, a water-dispersible micronised iron; Sunactive¨ ferric pyrophosphate, lecithin and emulsifiers. Results: The data showed that Sucrosomial Iron¨ (Sideral¨), is significantly more bioavaible than microencapsulated Ferric pyrophosphate ingredients, Lipofer¨ and Sunactive¨ and Ferrous Sulfate in Caco-2 cell model (Figure 1). Bibliography Au, A. P., Reddy, M. B. (2000). Caco-2 cells can be used to assess human iron bioavailability from a semipurified meal. J Nutr 130:1329-1334. Garcia et al. (1996). The Caco-2 cell culture system can be used as a model to study food iron availability. J Nutr 126:251-258. Hermida et al., Preparation and characterization of iron-containing liposomes: their effect on soluble iron uptake by Caco-2 cells Journal of Liposome Research, 2010, 1-10, Jovani et al. (2001) Calcium, iron, and zinc uptake from digests of infant formulas by Caco-2 cells. J Agric Food Chem 49:3480-3485. Kiss et al., (2014) Sucrose esters increase drug penetration, but do not inhibit p-glycoprotein in caco-2 intestinal epithelial cells J Pharm Sci. Oct;103(10):3107-19. Szuts A et al. (2008) Study of the effects of drugs on the structures of sucrose esters and the effects of solid-state interactions on drug release J Pharm Biomed Anal. 48: Figure 1. the graph shows the Ferritin levels of Caco-2 cells after iron formulations treatment. Sucrosomial Iron treated cells display significant increase of Ferritin synthesis compared to Lipofer and SunActive treated cells. Figure 1. the graph shows the Ferritin levels of Caco-2 cells after iron formulations treatment. Sucrosomial Iron treated cells display significant increase of Ferritin synthesis compared to Lipofer and SunActive treated cells. Disclosures Tarantino: Pharmanutra s.p.a.: Employment. Brilli:Pharmanutra s.p.a.: Employment.
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Szudzik, Mateusz, Rafał Starzyński, Aneta Jończy, Rafał Mazgaj, Małgorzata Lenartowicz, and Paweł Lipiński. "Correction: Mateusz, S., et al. Iron Supplementation in Suckling Piglets: An Ostensibly Easy Therapy of Neonatal Iron Deficiency Anemia. Pharmaceuticals 2018, 11, 128." Pharmaceuticals 12, no. 1 (January 29, 2019): 22. http://dx.doi.org/10.3390/ph12010022.
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Gómez-Ramírez, Susana, Elisa Brilli, Germano Tarantino, and Manuel Muñoz. "Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation." Pharmaceuticals 11, no. 4 (October 4, 2018): 97. http://dx.doi.org/10.3390/ph11040097.
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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 treatment compliance. Intravenous (IV) iron formulations are increasingly safer, but there is still a risk of infusion and hypersensitivity reactions and the need for a 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 unique structural, physicochemical and pharmacokinetic characteristics, together with high iron bioavailability and excellent gastrointestinal tolerance. The analysis of available evidence supports oral SI iron as a valid option for ID treatment, which is more efficacious and better tolerated than oral iron salts. SI has also demonstrated 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 most valuable first option for treating ID, even more for subjects with intolerance to or inefficacy of iron salts. Moreover, SI should be also considered as an alternative to IV iron for initial and/or maintenance treatment in different patient populations.
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Michalak, Sylwia Sulimiera. "Iron deficiency anemia – new possibilities of iron supplementation in various clinical conditions." Acta Haematologica Polonica 51, no. 4 (December 1, 2020): 212–19. http://dx.doi.org/10.2478/ahp-2020-0037.
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AbstractIron deficiency anemia (IDA) treatment is done to eliminate the causes of iron deficiency, iron supplementation, and rarely red blood cell transfusion. Divalent iron salts are the first line of oral treatment, but their use lead to frequent gastrointestinal adverse reactions. Iron is administered intravenously in the event of contraindications, intolerance, or inefficiency of oral therapy, but the parenteral route of drug delivery is not easily accepted by the patients. Intravenous preparations for single administration of a large dose of iron have a good therapy safety profile, but are more expensive than oral and are usually administered in a hospital setting. The availability of new iron compounds: sucrosomial iron, ferric citrate complexes, and ferric maltol widen the possibilities of IDA therapy and enable the better selection of iron preparations in various clinical situations. The innovative structure of sucrosomial iron leads to absorption in different ways (through endocytosis, the paracellular pathway, M cells of Peyer's patches), ensures high bioavailability, and good tolerance of therapy. Ferric citrate, in addition to iron supplementation, reduces phosphate levels, and is beneficial to chronic kidney disease. Ferric maltol is currently being studied for IDA treatment with various comorbidities. Some studies indicate that new iron formulas may be used where intravenous intake has been recommended so far. So, we can expect treatment with iron nanoparticles and drugs that affect the intestinal microflora in the future. The paper presents current knowledge about new iron preparations that are already available in everyday practice, but also those that are at various stages of pre-clinical and clinical studies.
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Brilli, Elisa, Asperti Michela, Magdalena Gryzik, Alessandro Lucchesi, Giovanni Martinelli, Maura Poli, and Germano Tarantino. "Study on Sucrosomial® Iron Endocytosis-Mediated Uptake and Enterocytes Release." Blood 132, Supplement 1 (November 29, 2018): 4892. http://dx.doi.org/10.1182/blood-2018-99-114523.
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Abstract Introduction: iron homeostasis is maintained by regulating the iron levels in plasma which is maintained by four coordinated processes: duodenal iron absorption, macrophage iron recycling, hepatic iron storage and erythropoiesis. Iron in the Fe2+ form is transported across the apical duodenal membrane by DMT1 and subsequently transferred to the blood via the iron exporter, Ferroportin the only know cell membrane iron exporter. Due to the presence of two check points at cellular levels, iron absorption and release are mainly regulated, because of this iron containing oral formulations are poorly absorbed and bioavailable. To overcome cellular barriers and increasing the bioavailability of supplemented iron forms, there is a need for new carriers that work protecting the iron as well as enhancing its intestinal absorption and release into the blood stream. Moreover thus reducing dosage and side effects. Sucrosomial® Iron (SI) represents an innovative oral iron-containing carrier in which ferric pyrophosphate is protected by a phospholipid bilayer membrane plus a sucrester matrix. To date, in vitro studies have shown that SI is mostly absorbed as vesicle-like structure, bypassing the conventional iron absorption pathway. Due to its behaviour at the gastrointestinal tract, SI is well tolerated and highly bioavailable compared to conventional iron salts. To deeply understand involvement of endocytosis in SI absorption and release, in vitro experiments using endocytosis and ferroportin inhibitors were carried out Aim: to study Sucrosomial® Iron uptake and release in different in vitro systems. Materials and Methods: CACO-2 and THP1 cells were used to investigate the role of FPN in Sucorsomial Iron release from cells. For release study, CACO-2 cells were exposed for 18h to quercetin (150mmol/L) in order to downregulate FPN expression. CACO-2 quercetin pre-treated cells were co-cultured with TPH1 cells, and SI or FAC were added. However, prior to measure cell Ferritin content, the incubation medium was discarded and cells were washed to remove quercetin. Iron uptake-release analysis was performed using co-culture transwell system between CACO-2 cells and TPH1. To investigate the cellular fate of cellular iron in quercetin treated CACO-2 and TPH1 cells we measured cell ferritin content. To inhibit endocytosis absorption pathway, CACO-2, THP1 and HepG2 cells were pre-treated with PitStop2 and Dyngo 4a inhibitors and then treated with SI, or Ferrous Sulfate (FS) or ferric ammonium citrate (FAC). Cellular Ferritin content was measured. Results: in order to understand the effect of quercetin on iron storage, we used CACO2 and TPH1 cells pre-treated with quercetin and then treated with SI, FAC or nothing (control). Quercetin-SI treated CACO-2 cells showed no differences in Ferritin expression compared to control cells (3,94 ngFTL/mg proteins Vs 4,56 ngFTL/mg proteins) while in quercetin-FAC treated cells ferritin expression was decreased compare to control cells (16,3 ngFTL/mg proteins Vs 27,55 ngFTL/mg proteins). In a similar manner, quercetin-SI treated TPH1 cells didn't show increase in Ferritin expression compared to control cells (20 ngFTL/mg proteins Vs 15,15 ngFTL/mg proteins), only in quercetin-FAC treated cells we observed a Ferritin expression increase compared to control untreated cells (16 ngFTL/mg proteins Vs 24 ngFTL/mg proteins). Results from experiments using endocytosis inhibitors showed that SI absorption in CACO-2 cells is inhibited using Dyngo4a (from 4ngFTL/mg proteins to 0,36 ngFTL/ mg proteisn) while PitStop3 seems to reduce SI absorption in THP1 (from 396 ngFL/mg protein to 199,91 ngFTL/mg proteins) and HepG2 cells (from 26,86 ngFL/mg proteins to 3,93 ngFTL/mg proteins), since ferritin expression significantly decrease only in SI treated cells. Conclusions: endocytosis pathway seems to be involved in SI cellular uptake but this process is regulated in different manner probably due to different cell types. Release experiments showed that cells treated with quercetin could reduce for a negative feedback DMT1 expression as well, affecting iron uptake from cells treated with FAC but not with SI and consequently, if SI is able to bypass commonly iron uptake mechanism, FPN inhibition did not show iron release perturbation from cells treated with SI. Disclosures Brilli: Pharmanutra s.p.a.: Consultancy. Martinelli:Janssen: Consultancy; Pfizer: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Roche: Consultancy; Abbvie: Consultancy; Novartis: Speakers Bureau; Amgen: Consultancy; Ariad/Incyte: Consultancy; Jazz Pharmaceuticals: Consultancy. Tarantino:Pharmanutra s.p.a.: Employment.
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Stuklov, Nikolai I. "Iron deficiency syndromes associated with diseases of the gastrointestinal tract: state-of-the-art and new prospects for treatment." Clinical Medicine (Russian Journal) 94, no. 6 (July 5, 2016): 410–18. http://dx.doi.org/10.18821/0023-2149-2016-94-6-410-418.
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Organs of the gastrointestinal tract (GIT) are essential for iron metabolism and hematopoiesis regulation. Iron deficiency is accompanied by a large number of diseases of GIT. The article discusses the problem of diagnosis and treatment of anemia, It describes mechanisms of development of anemia associated with bleeding, malabsorption, and chronic inflammation. It provides current data on the use of oral and intravenous iron-containing drugs, discusses advantages of the new oral form of sucrosomial iron for the treatment of anemia associated with GIT diseases.
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Barakat, Mohamad F., George Amin‐Youseff, and Darlington O. Okonko. "Oral sucrosomial iron in heart failure with a reduced ejection fraction." European Journal of Heart Failure 23, no. 4 (April 2021): 598–600. http://dx.doi.org/10.1002/ejhf.2176.
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Fabiano, Angela, Elisa Brilli, Letizia Mattii, Lara Testai, Stefania Moscato, Valentina Citi, Germano Tarantino, and Ylenia Zambito. "Ex Vivo and in Vivo Study of Sucrosomial® Iron Intestinal Absorption and Bioavailability." International Journal of Molecular Sciences 19, no. 9 (September 12, 2018): 2722. http://dx.doi.org/10.3390/ijms19092722.
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The present study aimed to demonstrate that Sideral® RM (SRM, Sucrosomial® Raw Material Iron) is transported across the excised intestine via a biological mechanism, and to investigate the effect that this transport route may produce on oral iron absorption, which is expected to reduce the gastrointestinal (GI) side effects caused by the bioavailability of non-absorbed iron. Excised rat intestine was exposed to fluorescein isothiocyanate (FITC)-labeled SRM in Ussing chambers followed by confocal laser scanning microscopy to look for the presence of fluorescein-tagged vesicles of the FITC-labeled SRM. To identify FITC-labeled SRM internalizing cells, an immunofluorescence analysis for macrophages and M cells was performed using specific antibodies. Microscopy analysis revealed the presence of fluorescein positive particulate structures in tissues treated with FITC-labeled SRM. These structures do not disintegrate during transit, and concentrate in macrophage cells. Iron bioavailability was assessed by determining the time-course of Fe3+ plasma levels. As references, iron contents in liver, spleen, and bone marrow were determined in healthy rats treated by gavage with SRM or ferric pyrophosphate salt (FP). SRM significantly increased both area under the curve (AUC) and clearance maxima (Cmax) compared to FP, thus increasing iron bioavailability (AUCrel = 1.8). This led to increased iron availability in the bone marrow at 5 h after single dose gavage.
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Mazgaj, Rafał, Mateusz Szudzik, Paweł Lipiński, Aneta Jończy, Ewa Smuda, Marian Kamyczek, Beata Cieślak, Dorine Swinkels, Małgorzata Lenartowicz, and Rafał R. Starzyński. "Effect of Oral Supplementation of Healthy Pregnant Sows with Sucrosomial Ferric Pyrophosphate on Maternal Iron Status and Hepatic Iron Stores in Newborn Piglets." Animals 10, no. 7 (June 29, 2020): 1113. http://dx.doi.org/10.3390/ani10071113.
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Background: The similarities between swine and humans in physiological and genomic patterns, as well as significant correlation in size and anatomy, make pigs an useful animal model in nutritional studies during pregnancy. In humans and pigs iron needs exponentially increase during the last trimester of pregnancy, mainly due to increased red blood cell mass. Insufficient iron supply during gestation may be responsible for the occurrence of maternal iron deficiency anemia and decreased iron status in neonates. On the other hand, preventive iron supplementation of non-anemic mothers may be of potential risk due to iron toxicity. Several different regimens of iron supplementation have been applied during pregnancy. The majority of oral iron supplementations routinely applied to pregnant sows provide inorganic, non-heme iron compounds, which exhibit low bioavailability and intestinal side effects. The aim of this study was to check, using pig as an animal model, the effect of sucrosomial ferric pyrophosphate (SFP), a new non-heme iron formulation on maternal and neonate iron and hematological status, placental transport and pregnancy outcome; Methods: Fifteen non-anemic pregnant sows were recruited to the experiment at day 80 of pregnancy and randomized into the non-supplemented group (control; n = 5) and two groups receiving oral iron supplementation—sows given sucrosomial ferric pyrophosphate, 60 mg Fe/day (SFP; n = 5) (SiderAL®, Pisa, Italy) and sows given ferrous sulfate 60 mg Fe/day (Gambit, Kutno, Poland) (FeSO4; n = 5) up to delivery (around day 117). Biological samples were collected from maternal and piglet blood, placenta and piglet tissues. In addition, data on pregnancy outcome were recorded.; Results: Results of our study show that both iron supplements do not alter neither systemic iron homeostasis in pregnant sows nor their hematological status at the end of pregnancy. Moreover, we did not detect any changes of iron content in the milk and colostrum of iron supplemented sows in comparison to controls. Neonatal iron status of piglets from iron supplemented sows was not improved compared with the progeny of control females. No statistically significant differences were found in average piglets weight and number of piglets per litter between animals from experimental groups. The placental expression of iron transporters varied depending on the iron supplement.
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Mazgaj, Rafał, Paweł Lipiński, Mateusz Szudzik, Aneta Jończy, Zuzanna Kopeć, Adrian M. Stankiewicz, Marian Kamyczek, Dorine Swinkels, Beata Żelazowska, and Rafał R. Starzyński. "Comparative Evaluation of Sucrosomial Iron and Iron Oxide Nanoparticles as Oral Supplements in Iron Deficiency Anemia in Piglets." International Journal of Molecular Sciences 22, no. 18 (September 14, 2021): 9930. http://dx.doi.org/10.3390/ijms22189930.
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Iron deficiency is the most common mammalian nutritional disorder. However, among mammalian species iron deficiency anemia (IDA), occurs regularly only in pigs. To cure IDA, piglets are routinely injected with high amounts of iron dextran (FeDex), which can lead to perturbations in iron homeostasis. Here, we evaluate the therapeutic efficacy of non-invasive supplementation with Sucrosomial iron (SI), a highly bioavailable iron supplement preventing IDA in humans and mice and various iron oxide nanoparticles (IONPs). Analysis of red blood cell indices and plasma iron parameters shows that not all iron preparations used in the study efficiently counteracted IDA comparable to FeDex-based supplementation. We found no signs of iron toxicity of any tested iron compounds, as evaluated based on the measurement of several toxicological markers that could indicate the occurrence of oxidative stress or inflammation. Neither SI nor IONPs increased hepcidin expression with alterations in ferroportin (FPN) protein level. Finally, the analysis of the piglet gut microbiota indicates the individual pattern of bacterial diversity across taxonomic levels, independent of the type of supplementation. In light of our results, SI but not IONPs used in the experiment emerges as a promising nutritional iron supplement, with a high potential to correct IDA in piglets.
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Abbati, Gianluca, Federica Incerti, Chiara Boarini, Francesca Pileri, Davide Bocchi, Paolo Ventura, Elena Buzzetti, and Antonello Pietrangelo. "Safety and efficacy of sucrosomial iron in inflammatory bowel disease patients with iron deficiency anemia." Internal and Emergency Medicine 14, no. 3 (November 29, 2018): 423–31. http://dx.doi.org/10.1007/s11739-018-1993-9.
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Fabiano, Angela, Elisa Brilli, Stefano Fogli, Denise Beconcini, Sara Carpi, Germano Tarantino, and Ylenia Zambito. "Sucrosomial® iron absorption studied by in vitro and ex-vivo models." European Journal of Pharmaceutical Sciences 111 (January 2018): 425–31. http://dx.doi.org/10.1016/j.ejps.2017.10.021.
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Lupo, Maria Giovanna, Noemi Biancorosso, Elisa Brilli, Germano Tarantino, Maria Pia Adorni, Greta Vivian, Marika Salvalaio, et al. "Cholesterol-Lowering Action of a Novel Nutraceutical Combination in Uremic Rats: Insights into the Molecular Mechanism in a Hepatoma Cell Line." Nutrients 12, no. 2 (February 9, 2020): 436. http://dx.doi.org/10.3390/nu12020436.
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Appropriate nutraceutical combinations may represent a valid approach to prevent vascular calcification associated with chronic kidney disease (CKD). In the present study, we tested the effect of a new nutraceutical combination named RenaTris®, containing MK-7, magnesium carbonate, and Sucrosomial® Iron, on vascular calcification in uremic rats. Rats were randomly divided into three groups, i.e., control (high-phosphate diet), uremic (high-phosphate diet containing 0.5% adenine), and supplemented uremic diet (0.5% adenine, MK-7, magnesium carbonate, and Sucrosomial® Iron). After six weeks, sera and vascular calcification were examined. The uremic diet increased creatinine and phosphate levels and induced extensive vascular calcification. The uremic condition also induced a mild hypercholesterolemic condition (+52% of total cholesterol; p < 0.05). The supplemented uremic diet did not reduce creatinine, phosphate levels, or vascular calcification, however, we observed a significant hypocholesterolemic effect (−18.9% in supplemental uremic vs. uremic diet; p < 0.05). Similar to simvastatin, incubation of cultured human hepatoma cells (Huh7) with MK-7 significantly reduced cholesterol biosynthesis (−38%) and induced 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase and low-density lipoprotein receptor (LDLR) at both mRNA and protein levels. The effect of MK-7 on LDLR was counteracted by the co-incubation with squalene. Unlike simvastatin, MK-7 reduced PCSK9 in Huh7. These results indicated that the new nutraceutical combination significantly impacts cholesterol metabolism and its supplementation may help to control mild hypercholesterolemic conditions in CKD patients.
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Mafodda, Antonino, D. Giuffrida, A. Prestifilippo, D. Azzarello, R. Giannicola, M. Mare, and R. Maisano. "Oral sucrosomial iron versus intravenous iron in anemic cancer patients without iron deficiency receiving darbepoetin alfa: a pilot study." Supportive Care in Cancer 25, no. 9 (April 9, 2017): 2779–86. http://dx.doi.org/10.1007/s00520-017-3690-z.
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Bastida, Guillermo, Claudia Herrera-de Guise, Alicia Algaba, Yolanda Ber Nieto, Jose Manuel Soares, Virginia Robles, Fernando Bermejo, Esteban Sáez-González, Fernando Gomollón, and Pilar Nos. "Sucrosomial Iron Supplementation for the Treatment of Iron Deficiency Anemia in Inflammatory Bowel Disease Patients Refractory to Oral Iron Treatment." Nutrients 13, no. 6 (May 22, 2021): 1770. http://dx.doi.org/10.3390/nu13061770.
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Iron deficiency anemia (IDA) is a common manifestation of Inflammatory Bowel Disease (IBD). Oral iron supplements are the treatment of choice, but are not always well tolerated. Sucrosomial® iron (SI) may represent an alternative. This prospective study assessed the tolerability and effectiveness of SI, and quality of life (QoL) of IDA-IBD patients who were intolerant to oral iron salts. The study included 52 individuals treated with 1 capsule/day for 12 weeks. Tolerability was assessed through a gastrointestinal symptom severity questionnaire. Hemoglobin (Hb) levels and clinical symptoms of IDA were analyzed. QoL was assessed using IBDQ-9 and EuroQoL questionnaires. The percentage of patients with excellent/good health increased from 42.9% to 94.3%. Mean Hb concentration significantly increased at all follow-up visits (p < 0.05). Almost all participants (96.9%) were adherent to the study medication. Patients’ QoL improved (IBDQ-9: from 60.9 to 65.5). Patients also improved in mobility (71.8% to 78.1%), usual activities (51.3% to 68.7%), pain/discomfort (41.0% to 53.1%), and extreme depression/anxiety problems (7.7% to 3.2%); they worsened in self-care (100% to 90.6%), but perceived an enhancement in their global health [EQ-VAS score: 61.9 (±26.1) to 66.9 (±20.3)]. SI was well tolerated and improved IDA symptoms, IBD activity, and patients’ QoL. In conclusion, SI should be considered in IDA–IBD patients.
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Bertani, Lorenzo, Domenico Tricò, Federico Zanzi, Giovanni Baiano Svizzero, Francesca Coppini, Nicola de Bortoli, Massimo Bellini, Luca Antonioli, Corrado Blandizzi, and Santino Marchi. "Oral Sucrosomial Iron Is as Effective as Intravenous Ferric Carboxy-Maltose in Treating Anemia in Patients with Ulcerative Colitis." Nutrients 13, no. 2 (February 12, 2021): 608. http://dx.doi.org/10.3390/nu13020608.
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Anemia is a frequent complication of ulcerative colitis, and is frequently caused by iron deficiency. Oral iron supplementation displays high rates of gastrointestinal adverse effects. However, the formulation of sucrosomial iron (SI) has shown higher tolerability. We performed a prospective study to compare the effectiveness and tolerability of oral SI and intravenous ferric carboxy-maltose (FCM) in patients with ulcerative colitis in remission and mild-to-moderate anemia. Patients were randomized 1:1 to receive 60 mg/day for 8 weeks and then 30 mg/day for 4 weeks of oral SI or intravenous 1000 mg of FCM at baseline. Hemoglobin and serum levels of iron and ferritin were assessed after 4, 8, and 12 weeks from baseline. Hemoglobin and serum iron increased in both groups after 4 weeks of therapy, and remained stable during follow up, without significant treatment or treatment-by-time interactions (p = 0.25 and p = 0.46 for hemoglobin, respectively; p = 0.25 and p = 0.26 for iron, respectively). Serum ferritin did not increase over time during SI supplementation, while it increased in patients treated with FCM (treatment effect, p = 0.0004; treatment-by-time interaction effect, p = 0.0002). Overall, this study showed that SI and FCM displayed similar effectiveness and tolerability for treatment of mild-to-moderate anemia in patients with ulcerative colitis under remission.
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Briguglio, Matteo, Silvana Hrelia, Marco Malaguti, Elena De Vecchi, Giovanni Lombardi, Giuseppe Banfi, Patrizia Riso, et al. "Oral Supplementation with Sucrosomial Ferric Pyrophosphate Plus L-Ascorbic Acid to Ameliorate the Martial Status: A Randomized Controlled Trial." Nutrients 12, no. 2 (January 31, 2020): 386. http://dx.doi.org/10.3390/nu12020386.
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Altered martial indices before orthopedic surgery are associated with higher rates of complications and greatly affect the patient’s functional ability. Oral supplements can optimize the preoperative martial status, with clinical efficacy and the patient’s tolerability being highly dependent on the pharmaceutical formula. Patients undergoing elective hip/knee arthroplasty were randomized to be supplemented with a 30-day oral therapy of sucrosomial ferric pyrophosphate plus L-ascorbic acid. The tolerability was 2.7% among treated patients. Adjustments for confounding factors, such as iron absorption influencers, showed a relevant response limited to older patients (≥ 65 years old), whose uncharacterized Hb loss was averted upon treatment with iron formula. Older patients with no support lost −2.8 ± 5.1%, while the intervention group gained +0.7 ± 4.6% of circulating hemoglobin from baseline (p = 0.019). Gastrointestinal diseases, medications, and possible dietary factors could affect the efficacy of iron supplements. Future opportunities may consider to couple ferric pyrophosphate with other nutrients, to pay attention in avoiding absorption disruptors, or to implement interventions to obtain an earlier martial status optimization at the population level.
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Ciudin, Andreea, Olga Simó-Servat, Jose Maria Balibrea, Ramon Vilallonga, Cristina Hernandez, Rafael Simó, and Jordi Mesa. "Response to oral sucrosomial iron supplementation in patients undergoing bariatric surgery. The BARI-FER study." Endocrinología, Diabetes y Nutrición 65, no. 1 (January 2018): 17–20. http://dx.doi.org/10.1016/j.endinu.2017.10.007.
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Ciudin, Andreea, Olga Simó-Servat, Jose Maria Balibrea, Ramon Vilallonga, Cristina Hernandez, Rafael Simó, and Jordi Mesa. "Response to oral sucrosomial iron supplementation in patients undergoing bariatric surgery. The BARI-FER study." Endocrinología, Diabetes y Nutrición (English ed.) 65, no. 1 (January 2018): 17–20. http://dx.doi.org/10.1016/j.endien.2018.01.002.
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Elli, Luca, Francesca Ferretti, Federica Branchi, Carolina Tomba, Vincenza Lombardo, Alice Scricciolo, Luisa Doneda, and Leda Roncoroni. "Sucrosomial Iron Supplementation in Anemic Patients with Celiac Disease Not Tolerating Oral Ferrous Sulfate: A Prospective Study." Nutrients 10, no. 3 (March 9, 2018): 330. http://dx.doi.org/10.3390/nu10030330.
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giordano, G., M. napolitano, and A. lucchesi. "PB2249: SUCROSOMIAL IRON SUPPORT IN PATIENT WITH IRON DEFICIENCY ANEMIA IS HIGLY EFFECTIVE IN IMPROVING ANEMIA REDUCING ERYPTOSIS AND M1 MACROPHAGES POLARIZATION." HemaSphere 6 (June 2022): 2119–20. http://dx.doi.org/10.1097/01.hs9.0000851824.38294.2e.
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Orlando, S., F. Ferretti, F. Branchi, V. Lombardo, A. Scricciolo, L. Doneda, M. Vecchi, L. Roncoroni, and L. Elli. "P.10.13 SUCROSOMIAL IRON SUPPLEMENTATION IN ANAEMIC PATIENTS WITH CELIAC DISEASE NOT TOLERATING ORAL FERROUS SULPHATE: A PROSPECTIVE STUDY." Digestive and Liver Disease 50, no. 2 (March 2018): e233. http://dx.doi.org/10.1016/s1590-8658(18)30648-0.
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Bongiovanni, T., G. Pasta, and G. Tarantino. "Sucrosomial® iron and folic acid supplementation is able to induce Il-6 levels variation in healthy trained professional athletes, regardless of the hemoglobin and iron values." Science & Sports 34, no. 3 (June 2019): 165–72. http://dx.doi.org/10.1016/j.scispo.2019.02.002.
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Karavidas, Apostolos, Efstratios Troganis, George Lazaros, Despina Balta, Ioannis‐Nektarios Karavidas, Eftihia Polyzogopoulou, John Parissis, and Dimitrios Farmakis. "Oral sucrosomial iron improves exercise capacity and quality of life in heart failure with reduced ejection fraction and iron deficiency: a non‐randomized, open‐label, proof‐of‐concept study." European Journal of Heart Failure 23, no. 4 (January 22, 2021): 593–97. http://dx.doi.org/10.1002/ejhf.2092.
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Scardino, Marco, Berardo Di Matteo, Federica Martorelli, Dario Tanzi, Elizaveta Kon, and Tiziana D’Amato. "Improved patient blood management and cost saving in hip replacement surgery through the implementation of pre-operative Sucrosomial® iron supplementation: a quality improvement assessment study." International Orthopaedics 43, no. 1 (September 20, 2018): 39–46. http://dx.doi.org/10.1007/s00264-018-4149-7.
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Mallaci Bocchio, R., M. Lo Monaco, G. Natoli, S. Scibetta, and S. Corrao. "A Randomized Controlled Pilot Study to Compare the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, Micronized Microencapsulated Ferric Pyrophosphate, and Intravenous Ferric Gluconate." Current Topics in Nutraceutical Research 20, no. 4 (June 23, 2022): 685–90. http://dx.doi.org/10.37290/ctnr2641-452x.20:685-690.
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Despite their gastrointestinal side effects, oral iron supplements are the first-line therapy in iron deficiency anemia. This study aims to compare different iron formulations in anemic outpatients. One-hundred and six outpatients with sideropenic microcytic hypochromic anemia (Hb < 12 g/dL for women, Hb < 13 g/dL for men) were enrolled and divided into two groups (Hb > 10 g/dL and Hb < 10 g/dL). One group was randomized (1:1) to receive sucrosomal ferric pyrophosphate or micronized microencapsulated ferric pyrophosphate, while the other group was randomized (1:1:1) to receive sucrosomal ferric pyrophosphate, micronized microencapsulated ferric pyrophosphate or intravenous ferric gluconate. After 3 months of follow-up, hemoglobin was significantly higher in the micronized microencapsulated ferric pyrophosphate group than in the sucrosomal ferric pyrophosphate group (1.87 vs 1.10; P = 0.04). No significant difference in adverse events was registered between the two groups. In patients with Hb > 10 g/dL, the pyrophosphate or micronized microencapsulated ferric pyrophosphate (30 mg/day) treatment in combination with folic acid (400 mcg), lactoferrin (10 mg), and vitamin C (180 mg) we found out to bring in a significant increase in hemoglobin, without any significant side effects. The reason for this effectiveness is probably due to its favorable bioavailability. Further comparative studies are needed with other forms of iron.
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Stuklov, Nikolay I., O. V. Knyazev, A. I. Parfenov, I. G. Basiladze, and A. V. Pivnik. "Comparison of efficiency of a new sucrosomal peroral form of iron with intravenous ferrotherapy in the treatment of anemia in inflammatory bowel diseases." Clinical Medicine (Russian Journal) 95, no. 12 (March 14, 2018): 1112–17. http://dx.doi.org/10.18821/0023-2149-2017-95-12-1112-1117.
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The article describes the role of iron deficiency in the development of anemia in inflammatory bowel diseases (IBD), existing approaches to treatment. The problems of insufficient effectiveness and poor tolerance of standard iron preparations are discussed, which is associated with the presence of malabsorption and chronic inflammation of the intestinal wall. The aim of the work was to determine the effectiveness of a standard approach to treatment with intravenous iron preparations in comparison with the new sucrsomal oral form of iron Sideral Forte in patients with anemia in IBD. The materials of the study included data from 57 patients with anemia and IBD. The results of examination of 28 patients and treatment of 29 patients with anemia and IBD were analyzed, of which 14 received Sideral Forte, 15 intravenous ferrotherapy. According to the results of the study, it is proved that in the IBD hypo-normochromic and micro-normocytic anemia is always associated with a violation of iron metabolism. The results of the application of these groups of iron preparations for 3 months showed a significant increase in the concentration of hemoglobin, serum iron, a more significant effect of the sucrsomal oral iron for normalization of the hemoglobin concentration.
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Pierelli, Luca, Alessandro De Rosa, Mauro Falco, Elsie Papi, Maria Rondinelli, Franco Turani, and Luca Weltert. "Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study." Surgical Technology Online 39 (June 1, 2021). http://dx.doi.org/10.52198/21.sti.39.cv1512.
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Background: Low preoperative haemoglobin is frequently observed in heart surgery patients and is associated with a significant decrease in haemoglobin between post-operative days 2 and 3, known as haemoglobin drift. Overall, these patients tend to receive many RBC transfusions. Since iron homeostasis is often impaired in these patients, restoration of iron availability might override iron-restricted erythropoiesis. However, reduced tolerance to oral iron salts has limited this strategy to intravenous iron administration. Study Design and Methods: The purpose of this study was to assess whether preoperative supplementation with oral sucrosomial iron, a new iron-delivery technology with improved tolerance and bioavailability, might be an effective strategy for this patient population. One thousand consecutive patients were randomized and received either a one-month course of sucrosomial iron (60 mg/day) or no treatment prior to elective heart surgery at a single high-volume centre (ClinicalTrials.gov NCT03560687). Primary end-points were haemoglobin concentration on the day of hospital admittance and number of blood transfusions. Secondary end-points were haemoglobin drift, tolerance of treatment and cost-effectiveness of sucrosomial iron administration. Results: Baseline haemoglobin in the treatment group was higher (by 0.67 g/dL; p<0.001) than that in the control group. The percentage of patients in the treatment group who required transfusion (35.4%) was half that in the control group (64.6%). The average number of transfused units per operation was 0.95 vs. 2.03 in the treatment and control groups, respectively. Haemoglobin drift was substantially similar in the two groups, and the tolerability of treatment was excellent (98%). The overall cost of treatment was 156 Euros less in the treatment group, expressed as a raw cost of transfusion. Conclusion: In elective heart surgery, routine preoperative sucrosomial iron administration seems to be a safe, well-tolerated and cost-effective strategy to increase preoperative haemoglobin and reduce the need for allogeneic blood transfusions.
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Giordano, Giulio, Mariasanta Napolitano, Valeria Di Battista, and Alessandro Lucchesi. "Oral high-dose sucrosomial iron vs intravenous iron in sideropenic anemia patients intolerant/refractory to iron sulfate: a multicentric randomized study." Annals of Hematology, December 2, 2020. http://dx.doi.org/10.1007/s00277-020-04361-3.
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AbstractIron 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.
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Mircoli, L., T. Tonella, and S. Carugo. "P213 ROLE OF ANEMIA AND IRON IMPLEMENTATION ON PROGNOSIS AND MANAGEMENT OF ELDERLY STEMI PATIENTS." European Heart Journal Supplements 24, Supplement_C (May 1, 2022). http://dx.doi.org/10.1093/eurheartj/suac012.205.
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Abstract Introduction Elderly patients with S–T elevation myocardial infarction (STEMI) presented a very high risk for both in–hospital and long–term morbility and mortality. Comorbidities plays a key role in prognosis, in particular anemia (pre–existent or acquired) is a more and more emerging clinical element able to influence short– and long–term clinical outcome. Prognostic role of anemia in elderly STEMI patients in not completely clarified. Purpose of the present study is to evaluate the role of anemia and its therapy by iron implementation in a very–old population of STEMI patients followed for 1 year after index event. Methods we considered all STEMI patients admitted in our Coronary Care Unit from 2020 to 2021 and we selected only people aged > 80 years–old (n = 120). Haemoglobin (Hb, g/dl) values were considered at admission (T0), at hospital discharge (T1) and after 6 month (T2). In hospital and 1 year mortality, treatment by primary PCI, major bleedings (TIMI criteria), need of transfusion, double antiplatelet therapy (DAPT) discontinuation, were considered and compared between groups of patients without and with anemia (A, Hb < 13.5 for men and <12 for women at T1) and without (NA group). Type of iron implementation (sucrosomial or not) and its tolerability were considered only for A group. Data were expressed as means±SD or % values. Results 18 patients (15%) presented anemia at T0 (women 66%), 4 (22%) of them showed a TIMI major in–hospital bleeding (3, 20%, required blood transfusion) whereas 5 (5%) in non anemic, in–hospital mortality was similar between anemic and non–anemic (18% vs 17%). Sixteen (14%) presented mild anemia at T1 (14%, A group), mean age were similar to NA group (years, 86±4 vs 85±5, A vs NA, ns). In A 4 (25%) died during follow–up vs 11 (13%) in NA group during 1 year follow–up. Treatment with primary PTCA (31% vs 39%, A vs NA, ns) were similar. DAPT discontinuation In A group 16 patiens were discharged with indication to long–term iron implementation therapy, 6 of them with sucrosomial. Incidence of iron discontinuation was 16% (1 pt) for sucrosomial vs 50% (5 pts) for non–sucrosomial. Conclusions In elderly STEMI patients, 1) anemia at hospital admission influences in hospital major bleedings and need of blood trasfusions. 2) anemia at hospital discharge seems to affect DAPT discontinuation and long–term mortality. 3) use of sucrosomial iron reduces probability of discontinuation of implementation therapy.
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Sahebnazar, Nika, Sara Tavassoli-Hojjati, and Saba Aghaei. "Effect of Sucrosomial® Iron and Iron Drop Diluted with Natural Fruit Juice on Microhardness of Primary Enamel." Frontiers in Dentistry, December 5, 2022. http://dx.doi.org/10.18502/fid.v19i35.11247.
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Objectives: Considering the high prevalence of consumption of iron drops, and the resultant reduction in microhardness of primary enamel, this in vitro study aimed to assess the effects of Sucrosomial® iron and iron drop diluted with natural fruit juice on microhardness of primary enamel.
Materials and Methods: This in vitro, experimental study evaluated 45 extracted sound primary anterior teeth, that were randomly assigned to three groups (n=15) of Sideral, Irofant, and Irofant + natural apple juice. The titratable acidity and pH of solutions were measured. After measuring the baseline microhardness by a Vickers hardness tester, the teeth in the three groups were exposed to the respective iron drop solutions at 37°C for 5 minutes. They were then rinsed with distilled water, and their secondary microhardness was measured. Data were analyzed using the dependent Student t-test, ANOVA, and ANCOVA (alpha=0.05).
Results: Irofant had the lowest pH and the highest titratable acidity among the tested solutions. A reduction in enamel microhardness occurred in all groups after exposure to iron drops (P=0.0001). The reduction in microhardness was significantly greater in Irofant group compared with Irofant + natural apple juice (P=0.0001). Also, the reduction in microhardness was significantly greater in Irofant + natural apple juice compared with Sideral iron drop group (P=0.0001).
Conclusion: Sideral iron drop with Sucrosomial iron has minimal adverse effect on microhardness of primary enamel. Also, dilution of iron drops with natural apple juice can be suggested as an effective strategy to decrease their adverse effects on microhardness of primary enamel.
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Riccio, Eleonora, Massimo Sabbatini, Ivana Capuano, Angela Maria Pellegrino, Luigi Annicchiarico Petruzzelli, and Antonio Pisani. "Oral Sucrosomial® iron versus intravenous iron for recovering iron deficiency anaemia in ND-CKD patients: a cost- minimization analysis." BMC Nephrology 21, no. 1 (February 22, 2020). http://dx.doi.org/10.1186/s12882-020-01716-w.
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Zuccarini, Andrea, Daniela Cicognini, Richard Tancredi, Alessandra Ferrari, Gianpiero Rizzo, Angioletta Lasagna, Riccardo Caccialanza, et al. "Randomized trial of sucrosomial iron supplementation in patients with chemotherapy-related anemia treated with ESA." Supportive Care in Cancer, June 9, 2022. http://dx.doi.org/10.1007/s00520-022-07184-2.
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Szudzik, Mateusz, Rafał Mazgaj, Paweł Lipiński, Robert Staroń, Aneta Jończy, Marek Pieszka, Małgorzata Lenartowicz, et al. "Innovative oral sucrosomial ferric pyrophosphate-based supplementation rescues suckling piglets from iron deficiency anemia similarly to commonly used parenteral therapy with iron dextran." Annals of Animal Science, September 18, 2020. http://dx.doi.org/10.2478/aoas-2020-0084.
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AbstractIron deficiency is the most common mammalian nutritional deficiency during the neonatal period. However, among mammalian species neonatal iron deficiency anemia (IDA), the most severe consequence of iron scarcity, occurs regularly in pigs. Although intramuscular supplementation of piglets with high amounts of iron dextran (FeDex) is largely considered an appropriate preventive therapy for IDA prophylaxis, an increasing evidence shows that it negatively affects pig physiology. The aim of our study was to evaluate the efficacy of non-invasive supplementation of piglets with sucrosomial ferric pyrophosphate (SFP), a highly bioavailable dietary iron supplement in preventing IDA, in humans and mice. Results of our study show that SFP given to piglets per os in the amount of 6 mg Fe daily efficiently counteracts IDA at a rate comparable with the traditional FeDex-based supplementation (100 mgFe/kG b.w.; i.m. injection). This was indicated by physiological values of red blood cell indices and plasma iron parameters measured in 28-day old piglets. Moreover, SFP-supplemented piglets showed significantly lower (P ≤0.05) plasma level of 8-isoprostane, a biomarker for oxidative stress compared to FeDex-treated animals, implying lesser toxicity of this order of iron replenishment. Finally, supplementation with SFP does not increase considerably the blood plasma hepcidin, a peptide that acts to inhibit iron absorption from the diet. SFP emerges as a promising nutritional iron supplement, with a high potential to be adopted in the postnatal period.
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Torreiter, Patrick Paul, Camilla Drexler-Helmberg, Wolfgang Schimetta, Petra Krakowitzky, Wolfgang Helmberg, and Peter Schlenke. "Pilot Study to Gain First Indications for the Impact of a 3-Month’s Oral Intake of a Sucrosomial Iron Supplement on Hemoglobin in Iron-Deficient Blood Donors." Transfusion Medicine and Hemotherapy, December 6, 2022, 1–8. http://dx.doi.org/10.1159/000527577.
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<b><i>Introduction:</i></b> Regular whole blood donors often suffer from iron deficiency (ID) or iron deficiency anemia due to the loss of 200–300 mg of iron with each donation. Hemoglobin (Hb) as donor eligibility criterion reflects iron stores only poorly. ID in blood donors is typically prevented or treated with orally administered ferrous salts, which frequently cause gastrointestinal side effects. A high daily oral iron dose is counterproductive due to hepcidin upregulation. Oral sucrosomial iron (<sub>sucr</sub>iron) is encapsulated ferric pyrophosphate that may be an option for blood donors due to its supposed high bioavailability and good tolerability. <b><i>Methods:</i></b> This monocentric single-cohort pilot study included fifty whole blood donors (divided into premenopausal women, postmenopausal women, and men) who did not meet Hb donation criteria. Participants aged 18–65 years with ferritin <30 ng/mL and venous Hb <12.5 g/dL in women and Hb <13.5 g/dL in men received oral <sub>sucr</sub>iron (30 mg iron) for 90–120 days. Primary endpoints were the increase of Hb and ferritin. <b><i>Results:</i></b> Forty-seven participants completed the study. With the limitation that no control group was included, there was a substantial overall median increase of 0.94 g/dL Hb and 4.97 ng/mL ferritin (standardized on 90 days of iron intake). These value improvements were likewise observed in each of the subgroups. <sub>sucr</sub>iron was very well tolerated, with almost no gastrointestinal side effects identified. <b><i>Conclusion:</i></b> A clear increase of Hb and ferritin was observed after the intake of <sub>sucr</sub>iron, so it may be a reasonable and useful alternative to traditional oral iron therapy. The ease of administration, pleasant taste, dietary supplement status, and, most importantly, good tolerability highlight the value of <sub>sucr</sub>iron supplementation.
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Reggiani, Francesco, Graziano Colombo, Emanuela Astori, Lucia Landoni, Silvia Finazzi, Aldo Milzani, Claudio Angelini, Isabella Dalle-Donne, and David Cucchiari. "Preliminary experience on the use of sucrosomial iron in hemodialysis: focus on safety, hemoglobin maintenance and oxidative stress." International Urology and Nephrology, September 12, 2021. http://dx.doi.org/10.1007/s11255-021-02983-8.
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Elio, Venturini, Venturini Veronica, and Francesco Giallauria. "Abstract 13109: Oral and Intravenous Iron Therapy for Iron Deficiency Anemia After Cardiac Surgery." Circulation 142, Suppl_3 (November 17, 2020). http://dx.doi.org/10.1161/circ.142.suppl_3.13109.
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Introduction: cardiac surgery is associated with a high risk to develop iron deficiency anemia (IDA) with impact on the Cardiac Rehabilitation (CR) program. Sucrosomial Iron (SI) is a new oral iron with good gastrointestinal compliance and bioavailability Hypothesis: to compare SI with Ferric Carboxymaltose (FCM) i.v. the gold standard treatment for IDA. Methods: 67 consecutive patients admitted to a CR unit after cardiac surgery (27 CABG, 29 valves/aortic surgery, 11 CABG+valves) were alternately treated with SI or FCM. Blood parameters were assessed at the admission (8-10 days after surgery) (T1), at discharge (18-22 days after surgery) (T2) and 10 days from discharge (T3). The study design provides for a single dose of 1000 mg of FCM at T1 or a dose of 120 mg of SI per day for the first 8-10 days after T1; then SI was scaled to 30 mg/die up to T3. Two groups were comparable in terms of age (SI vs FCM: 67.3 ± 12.8 vs 70.2 ± 12.2) and ejection fraction (SI vs FCM: 52.7% ± 7.8 vs 53.9% ± 5.4). Because the small sample size, non-normal distributed longitudinal variables were logarithmically transformed, to guarantee the maximum possible power to the analysis. Results: data are shown in the following table. At T1, two treatment groups showed no statistically significant difference. Hemoglobin significantly increased in both groups, without significant difference at T3. Transferrin saturation and Sideremia significantly increase in both groups, although the correction is faster with FCM. Ferritin, elevated to baseline for inflammatory condition after surgery, is reduced in the SI group, while it increases significantly in FCM group. Conclusions: SI is able to correct post-surgical IDA in times and ways comparable to i.v. FCM. The hyperferritinemia observed with FCM at T2 may be due to a low-grade pro-inflammatory effect correlated to the high level of iron deposition in macrophages. SI is able to recover IDA and to achieve normal Ferritin values, avoiding the risk of hyperferritinemia.
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"Sucrosomal Iron Supplementation in Blood Donors." Case Medical Research, January 31, 2020. http://dx.doi.org/10.31525/ct1-nct04250298.
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Venturini, E., G. Masini, and F. Giallauria. "Treatment of iron deficiency anemia after cardiac surgery." European Journal of Preventive Cardiology 29, Supplement_1 (May 1, 2022). http://dx.doi.org/10.1093/eurjpc/zwac056.217.
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Abstract Funding Acknowledgements Type of funding sources: None. Background Iron deficiency anemia (IDA) after cardiac surgery (CS) increases mortality, serious adverse events and length of stay. Aim of the study was to compare the efficacy of Sucrosomal Iron (SI) on IDA and hematinic deficiencies (HD) in patients (P) after CS, compared to i.v. Ferric Carboxymaltose (FCM). SI was chosen for its peculiar intestinal absorption properties such as to overcome the hepcidin's block. Methods 106 consecutive anemic P were tested for HD after the admission in Cardiac Rehabilitation and alternately treated with SI (56) or FCM (54). The study design included a single dose of 1000 mg of FCM at T1 (8-10 days CS) or a dose of 120 mg of SI per day from T1 to T2 (on the day of discharge 10 days after T1); since then the SI was reduced to 30 mg per day until T3 (follow-up, 10 days after T2). Measures of efficacy included changes from baseline in Hb, HD, natriuretic peptides (NP), C-reactive protein (CRP), and the 6-minute-walking-test (6MWT). Results The data are shown in the Table. At T1, two treatment groups did not show statistically significant differences. Hb increased significantly (p<0.001), with no differences between SI and FCM. Transferrin saturation and sideremia significantly increased, albeit more rapidly with FCM. Ferritin, elevated at baseline for inflammation due to CS, decreases to T3 with SI, while significantly increases in the FCM group. NP were reduced with both treatments, but not significantly; CRP, on the other hand, was significantly reduced over time. At 6MWT the distance increased significantly with no difference between SI and FCM. Conclusions SI and FCM show similar efficacy on HD, starting from Hb, in P with IDA, after CS. The quick response to treatment, comparable between SI and FCM, could support the choice of oral iron, with organizational and cost benefits. In addition, was shown a positive impact on functional capacity, assessed with the 6MWT, for the first time similar between an oral and i.v. iron. Inflammation was reduced, but only SI is able to recover Hb levels, avoiding the risk of hyperferritinemia.