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Overcoming iron deficiency: An innovative oral formulation

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The human body contains about 3-4g of iron, which is mostly recycled and distributed between the bloodstream and various organs. The amount that we introduce daily with food is very low, about 1-2 mg, and derives mainly from foods such as liver, seafood, meat, fish, milk, some types of green vegetables (spinach), legumes (beans), dried fruit and cocoa.

Dietary iron can be divided into two forms: heme iron and non-heme iron. Heme iron comes in the form of a ferrous ion (Fe2+) and is bound to particular proteins (globins) that favor its entry into the bloodstream; about 15-35% is absorbed by the intestine. Heme iron represents 40% of the iron present in meat foods.

Non-heme iron, on the other hand, can be found as a ferrous ion (Fe2+) or as a ferric ion (Fe3+), according to its oxidation state, and is found in vegetables. While ferrous iron is soluble and easily passes inside duodenal enterocytes (intestinal cells), ferric iron must be transformed into Fe2+ to be absorbed by the intestine. The absorption of non-heme iron is therefore low, about 5-12%.

Once it enters the bloodstream, iron circulates bound to a specific transport protein, called transferrin, which is carried throughout the body and is partly stored in the form of ferritin mainly in the liver, spleen, bone marrow, as well as in myoglobin within muscle tissue.​This is the case not only for dietary iron, but also for iron from oral food supplements and drugs.

Iron Deficiency and Iron Deficiency Anemia have been widely investigated in patients with acute and chronic heart failure. Iron deficiency (ID), frequently associated with iron deficiency anemia (IDA), is one of the most important dietary disorders, and affects about one third of the population. Individuals at high risk of ID include children, the elderly and women, especially during pregnancy and menstruation.1

In recent years, ID and IDA have been widely investigated in patients with acute and chronic heart failure, recording an average of 50%.​ID is a condition characterized by a low level of iron in the body and, if not recovered, leads to an anaemic clinical condition. On the other hand, IDA occurs when the body is not able to satisfy the right level of haemoglobin production, which is essential to ensure the oxygenation of tissues and cells of the body.

Based on WHO3​ recommendations, the accepted values for haemoglobin are:

Man: ​≥130 g/dL

Woman:​ ≥120 g/dL

Child:​ ≥110 g/dL

When hemoglobin values are lower than those indicated, IDA is diagnosed. ID and IDA are commonly treated with oral iron salts. The real limit of oral iron supplements is their absorption, because iron receptors (e.g. DMT1, Ferroportin), in particular condition, such as inflammation, allow limited absorption and utilization of iron. This can lead to gastrointestinal side effects and as a result, reduced compliance and frequent drop outs by patients.4

Sucrosomial® Iron is an innovative oral iron formulation in which ferric pyrophosphate is protected by a matrix of phospholipids and sucrose esters of fatty acids (Sucrosome®). Sucrosome® allows the iron to pass intact by the gastrointestinal tract, and since the mineral does not in contact directly by the body, it does not cause the main adverse reaction due to the conventional iron salts. The innovation of Sucrosomial® technology is characterized by an excellent tolerability and it allows the iron intake anytime in the day (with or without food), for long periods of time, and prevents any discomfort commonly associated with iron intake, such as metallic and unpleasant aftertaste, irritation of the gastric mucosa, nausea or constipation. Overcoming the limits related to the conventional supplementation of iron, Sucrosomial® iron promotes the intake of this important nutrient in all situations of deficiency or increased needs for iron.

Scientific evidence in cardiology, such as the study Short-Term Treatment of Iron Deficiency Anemia After Cardiac Surgery​ by Dr. E. Venturini has shown that SiderAL® exhibits efficacy and possesses a high profile of tolerability in patients suffering from cardiological diseases. This demonstrates that Sucrosomial® Iron can be a viable alternative to recover iron deficiency, even after cardiac surgery, in a formulation that is administered orally.

It is important to remember that an iron deficiency can lead to a low quality of life and a prolonged post-surgery rehabilitation. It is necessary to evaluate a preventive iron supplementation in all patients undergoing surgery to improve clinical outcomes and improve their quality of life.

References

1.​ Hurrell R,; Egli I. Iron bioavailability and dietary reference values​Am J Clin Nutr 2010; 91: 1461S-7S
2.​ S. Gómez-Ramírez, E. Brilli, G. Tarantino, M. Muñoz. Sucrosomial® Iron: A New Generation
Iron for Improving Oral Supplementation. Pharmaceuticals (Basel).2018 Oct 4;11(4):97.
3​. Nutritional anaemias: tools for effective prevention and control​ (2017).
4​. Tolkien, Z.; Stecher, L.; Mander, A.P.; Pereira, D.I.; Powell, J.J. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: A systematic review and meta-analysis. PLoS ONE 2015, 10,e0117383.

Additional references

R.J. Stoltzfus. Defining Iron-deficiency Anemia in Public Health Terms: Time for Reflection, J. Nutr. 131 (2001) 565S–S567.
von Haehling S.; N. Ebner N.; R. Evertz, P,; et al. Iron Deficiency in Heart Failure: An Overview, JACC Heart Fail 7 (1) (2019) 36-46.
Cohen-Solal A.; Damy T.; Terbah M.; et al. High prevalence of Iron Deficiency in Patients with Acute Decompensated Heart Failure. Eur J Heart Fail 2014; 16:984-91.
Cleland J.G.F.; Zhang J.; Pellicori P.; et al. Prevalence and Outcomes of Anemia and Hematinic Deficiencies in Patients with Chronic Heart Failure, JAMA Cardiol. 1 (5) (2016) 539.
Venturini E;, et al. Short-Term Treatment of Iron Deficiency Anemia After Cardiac Surgery. Int J Cardiol Heart Vasc. 2022 May 2;40:101038.
Karavidas A.; et al. 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. Eur J Heart Fail. 2021 Apr;23(4):593-597.

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