Keywords
Anemia
Sucrosomial Iron
Tolerability
How to Cite
Abstract
Anemia is a highly prevalent condition worldwide, with iron deficiency (ID) being its leading etiology(1,2). IDA is usually treated with oral iron salts, but up to 50% of patients complain of gastrointestinal side effects (GI AEs), leading to reduced compliance and efficacy(8-10). Sucrosomial iron (SI) is a relatively new oral iron formulation with a high iron bioavailability and excellent gastrointestinal tolerance(11,12). This study aimed at assessing the GI tolerance and efficacy of SI compared to conventional oral iron formulations. We have analyzed the electronic medical histories of consecutive patients presenting with an IDA diagnosis and were prescribed a 12-week course of oral iron with SI (SI group; n=80) or one conventional iron formulation (Control group; n=96) from March to December 2023. Patients were followed for tolerance and hematological response every 4 weeks after treatment initiation. Data were analyzed according to the intention-to-treat (ITT) and the per-protocol (PP) principles. The incidence of GI AEs (main outcome variable) was significantly higher in the control group compared to the SI group (32% vs. 11%, respectively; p=0.001; ITT analysis). The mean of individual net Hb increment was higher in the SI group (+0.6 g/dL; P=0.025; PP analysis). Ferritin and TSAT values improved along the study period, without differences between groups. There was a trend towards a greater rate of anemia correction in the SI group (58% vs. 69%, respectively; P=0.162; ITT analysis), which was significant for patients with baseline Hb > 9 g/ dL (54% vs. 5%, respectively; p=0.01). The study results seem to confirm that oral SI showed a better GI tolerance and was at least as efficacious as conventional oral iron formulations in correcting IDA and improving iron parameters.
References
World Health Organization (WHO). Haemoglobin Concentrations for the Diagnosis of Anaemia and Assessment of Severity. WHO/NMH/NHD/MNM/11.1. vailable online at:https://apps.who.int/iris/bitstream/handle/10665/85839/WHO_NMH_NHD_MNM_11.1_eng.pdf (Accesed 22 January 2023).
Gardner W, Kassebaum N. Global, Regional, and National Prevalence of Anemia and Its Causes in 204 Countries and Territories, 1990–2019. Curr Dev Nutr. 2020; 4(Supplement_2):830. doi:10.1093/cdn/nzaa053_035.
Safiri S, Kolahi AA, Noori et al. Burden of anemia and its underlying causes in 204 countries and territories, 1990–2019: results from the Global Burden of Disease Study 2019. J Hematol Oncol. 2021; 14: 185. doi: 10.1186/s13045-021-01202-2.
Pasricha SR, Tye-Din J, Muckenthaler, MU, Swinkels DW. Iron deficiency. Lancet. 2021; 397: 233–48. doi:10.1016/S0140-6736(20)32594-0.
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
Pratt, JJ, Khan KS. Non-anaemic iron deficiency—A disease looking for recognition of diagnosis: A systematic review. Eur J Haematol. 2016; 96: 618–628.
Muñoz M, Gómez-Ramírez S, Besser M et al. Current misconceptions in diagnosis and management of iron deficiency. Blood Transfus. 2017; 15: 422–437. doi: 10.2450/2017.0113-17.
De Franceschi L, Iolascon A, Taher A, Cappellini MD. Clinical management of iron deficiency anemia in adults: Systemic review on advances in diagnosis and treatment. Eur J Intern Med. 2017; 42: 16–23. doi:1016/j.ejim.2017.04.018.
Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: A systematic review and meta-analysis. PLoS ONE. 2015; 10:
e0117383. doi: 10.1371/journal.pone.0117383.
Cancelo-Hidalgo MJ, Castelo-Branco C, Palacios S, Haya-Palazuelos J, Ciria-Recasens M, Manasanch J, Perez-Edo L. Tolerability of different oral iron supplements: A systematic review. Curr Med Res Opin. 2013;29:291–303. doi: 10.1185/03007995.2012.761599.
Gómez-Ramírez S, Brilli E, Tarantino G, Muñoz M. Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation. Pharmaceuticals (Basel). 2018 Oct 4;11(4):97. doi: 10.3390/ph11040097.
Gómez-Ramírez S, Brilli E, Tarantino G, Girelli D, Muñoz M. Sucrosomial® Iron: An Updated Review of Its Clinical Efficacy for the Treatment of Iron Deficiency. Pharmaceuticals (Basel). 2023 Jun 6;16(6):847.
Moretti D, Goede JS, Zeder C et al. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted Young women. Blood. 2015;126:1981–1989. doi: 10.1182/blood-2015-05-642223.
Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015; 372: 1832–1843. doi: 10.1056/NEJMra1401038.
Patel N, Silvey SG, Arora P, Feldman GM. Optimal Oral Iron Therapy for Iron Deficiency Anemia Among US Veterans. JAMA Netw Open. 2024 May 1;7(5):e2414305. doi: 10.1001/jamanetworkopen.2024.14305.
Pasupathy E, Kandasamy R, Thomas K, Basheer A. Alternate day versus daily oral iron for treatment of iron deficiency anemia: a randomized controlled trial. Sci Rep. 2023 Feb 1;13(1):1818. doi: 10.1038/s41598-023-29034-9.
von Siebenthal HK, Gessler S, Vallelian F et al. Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. E Clinical Medicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286.
Bertani L, Tricò D, Zanzi F et al. Oral Sucrosomial Iron Is as Effective as Intravenous Ferric Carboxy-Maltose in Treating Anemia in Patients with Ulcerative Colitis. Nutrients. 2021 Feb 12;13(2):608. doi: 10.3390/nu13020608.
Giordano G, Napolitano M, Di Battista V, Lucchesi A. Oral high-dose sucrosomial iron vs intravenous iron in sideropenic anemia patients intolerant/refractory to iron sulfate: a multicentric randomized study. Ann ematol. 2021 Sep;100(9):2173-2179. doi: 10.1007/s00277-020-04361-3. 20. Schreiner P, Martinho-Grueber M, Studerus D et al, on behalf of Swiss Ibdnet, an official working group of the Swiss Society of Gastroenterology Nutrition in inflammatory bowel disease. Digestion. 2020;101:120–135. doi: 10.1159/000505368.
All material published in the journal HEMATOLOGÍA (electronic and print version) is transferred to the Argentinean Society of Hematology. In accordance with the copyright Act (Act 11 723), a copyright transfer form will be sent to the authors of approved works, which has to be signed by all the authors before its publication. Authors should keep a copy of the original since the journal is not responsible for damages or losses of the material that was submitted. Authors should send an electronic version to the email: revista@sah.org.ar