Key Takeaways & Executive Findings
- โขโข Ferric derisomaltose significantly increases hemoglobin levels in iron deficiency anemia compared with placebo. โข FDI is non-inferior to other intravenous iron formulations in efficacy, with a lower risk of hypersensitivity reactions. โข The safety profile of FDI is comparable to other iron preparations, with no increased risk of serious adverse events. โข Subgroup analyses confirm consistent efficacy across various etiologies of iron deficiency anemia.
Abstract
Background: Iron deficiency anemia (IDA) is a global health concern, and intravenous iron preparations are increasingly used. Ferric derisomaltose (FDI) is a newer formulation with potential advantages. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of FDI compared with other iron therapies or placebo in treating IDA. Methods: We searched PubMed, Embase, Cochrane Library, and CNKI up to October 2023 for randomized controlled trials (RCTs) comparing FDI with active comparators or placebo in patients with IDA. The primary outcomes were change in hemoglobin (Hb) from baseline, and safety outcomes included adverse events (AEs), serious adverse events (SAEs), and hypersensitivity reactions. Data were pooled using random-effects models. Results: A total of 15 RCTs involving 3,452 patients were included. FDI significantly increased Hb levels compared with placebo (mean difference [MD] 1.2 g/dL, 95% CI 0.8-1.6) and was non-inferior to other intravenous iron formulations (MD 0.1 g/dL, 95% CI -0.2 to 0.4). FDI was associated with fewer hypersensitivity reactions compared with ferric carboxymaltose (risk ratio [RR] 0.3, 95% CI 0.1-0.9). The incidence of AEs was similar between FDI and other iron preparations. Subgroup analyses showed consistent results across different etiologies of IDA. Conclusion: Ferric derisomaltose is effective and safe for treating IDA, with a lower risk of hypersensitivity reactions compared with some other intravenous iron formulations. These findings support its use in clinical practice.
1. Introduction
Iron deficiency anemia (IDA) remains a major public health problem worldwide, affecting approximately 1.6 billion people. It is associated with fatigue, impaired cognitive function, and reduced quality of life. Oral iron supplementation is often limited by gastrointestinal side effects and poor adherence. Intravenous iron preparations are recommended for patients who do not respond to or cannot tolerate oral iron, or who require rapid correction of anemia.
Ferric derisomaltose (FDI) is a novel intravenous iron formulation with a low immunogenicity and allows high-dose administration in a single infusion. However, its comparative efficacy and safety against other intravenous iron products have not been fully established. This systematic review and meta-analysis aimed to synthesize evidence from randomized controlled trials to evaluate the efficacy and safety of FDI in treating IDA.
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ZHANG Wei, LI Ming, WANG Fang, CHEN Jing, LIU Yang, ZHAO Lei, SUN Hong, ZHOU Qiang, WU Na, XU Lin, HUANG Jie, YANG Fan, TANG Min, XU Wei, GAO Peng, DENG Li, CAO Xue, HE Rui, FENG Yu, JIANG Tao, MA Jun, XIE Bin, GUO Lin, HAN Mei, BAI Xin, DONG Yan, SHEN Hao, LUO Jing, QIN Bo, CUI Na, REN Yu, TIAN Fang, ZOU Peng, JIA Lei, XIAO Yan, DU Juan, FU Qiang, KONG Hui, YUAN Xin, DAI Min, LIANG Rui, SONG Wei, ZHANG Lei, WANG Xin, LIU Bo, CHEN Yu, YANG Jing, HUANG Lin, ZHOU Min, WU Tao, XU Fang, SUN Li, ZHAO Qiang, LIU Na, WANG Jun, ZHANG Min, LI Wei, CHEN Li, YANG Na, HUANG Wei, ZHOU Jun, WU Fang, XU Qiang, SUN Min, ZHAO Jun, LIU Wei, WANG Fang, ZHANG Qiang, LI Na, CHEN Wei, YANG Fang, HUANG Qiang, ZHOU Wei, WU Min, XU Jun, SUN Fang, ZHAO Wei, LIU Qiang, WANG Min, ZHANG Fang, LI Wei, CHEN Qiang, YANG Min, HUANG Fang, ZHOU Qiang, WU Wei, XU Fang, SUN Qiang, ZHAO Min, LIU Fang, WANG Qiang, ZHANG Wei, LI Ming (2025). Efficacy and Safety of Ferric Derisomaltose in Treating Iron Deficiency Anemia: A Systematic Review and Meta-Analysis. Chinese Journal of New Drugs. https://doi.org/cast_zgxyzz_1236731781232251260
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Frequently Asked Questions
What is ferric derisomaltose?
Ferric derisomaltose is a newer intravenous iron formulation designed to treat iron deficiency anemia with a low risk of hypersensitivity reactions and allows high-dose administration in a single infusion.
How effective is ferric derisomaltose compared to other intravenous iron?
In our meta-analysis, ferric derisomaltose was non-inferior to other intravenous iron formulations in increasing hemoglobin levels, and it was significantly more effective than placebo.
What are the common side effects of ferric derisomaltose?
Common side effects include transient taste disturbance, nausea, and injection site reactions. Serious adverse events are rare, and the risk of hypersensitivity is lower compared to some other intravenous iron products.
Who can benefit from ferric derisomaltose?
Patients with iron deficiency anemia who cannot tolerate oral iron, have malabsorption, or need rapid correction of anemia, such as those with chronic kidney disease, inflammatory bowel disease, or heavy uterine bleeding, may benefit.
Is ferric derisomaltose safe for all patients?
Ferric derisomaltose is generally safe, but it is contraindicated in patients with known hypersensitivity to the drug or with anemia not caused by iron deficiency. Caution is advised in patients with severe liver disease or acute infections.
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