Abstract
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.
Highlights
Data from 187 countries from 2010 revealed that anemia affected up to one-third of the global population, though prevalence varied widely across regions, and iron deficiency (ID) was responsible for about 50% of anemia cases [1]
Poor intake Inappropriate diet with deficit in bioavailable iron and/or ascorbic acid Malabsorption Medications (AntiH2, PPI, antacids, etc.) Increased hepcidin levels (e.g., IRIDA or anemia of chronic inflammation (ACI)) Molecular defects in iron transport proteins
Sucrester effects depend on both the hydrophilic-lipophilic balance and the fatty acid chain length; the choice of the appropriate raw material is crucial for developing a formulation with absorption enhancer properties
Summary
Data from 187 countries from 2010 revealed that anemia affected up to one-third of the global population, though prevalence varied widely across regions, and iron deficiency (ID) was responsible for about 50% of anemia cases [1]. In a systematic analysis in the Global Burden of Disease Study 2016, iron-deficiency anemia (IDA) was the fourth leading cause of years lived with disability, especially in women [2]. Increased demands: Body growth (infancy and childhood) Pregnancy and lactation Recovery from blood loss Treatment with erythropoiesis stimulating agents. Increased iron losses: Bleeding trauma Gastrointestinal bleeding (peptic ulceration, neoplasia, inflammatory bowel disease, vascular malformations, medications [anti-inflammatory, anti-platelet or anticoagulant agents]) Genitourinary bleeding Menses and multi-parity Multiple diagnostic phlebotomies (medical “vampirism”) Blood donation Dialysis ( hemodialysis).
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