Ferric Carboxymaltose May Improve Outcomes For Subgroups of Iron Deficiency Anemia

Ferric carboxymaltose may improve hemoglobin and ferritin levels in people with underlying iron deficiency anemia (IDA) over iron sucrose, according to a new review and meta-analysis of randomized controlled trials.1

“This systematic review and meta-analysis provide a potential advantage of FCM over IS in improving hemoglobin and ferritin levels, particularly among patients with gynecological disorders underlying IDA. While both iron preparations demonstrated comparable efficacy in the general population, the findings underscore the importance of considering the specific etiology of anemia when choosing between these treatments,” lead investigator Lokman H Tanrıverdi, İnönü University Faculty of Medicine, Department of Medical Pharmacology, Malatya, Turkey, and colleagues wrote.1

Tanrıverdi and colleagues conducted a systematic literature search across PubMed, Ovid Medline, Web of Science, Scopus, and the Cochrane Library up to Jan 1, 2024, and identified trials directly comparing FCM and IS treatments in adult patients with IDA. They conducted meta-analyses with inverse variance random effects models to determine the primary outcome of change in hemoglobin levels during follow-up.

“Previous randomized controlled trials have examined the comparative efficacy and safety of FCM and IS, particularly in the treatment of anemia in various populations. However, the using of FCM and IS in different patient populations and clinical contexts has shown varying efficacy and safety results2,” investigators wrote.

The analysis included 14 trials with a total of 4757 patients. The investigators found that FCM resulted in a nonsignificant increase in hemoglobin levels (mean difference [MD], 0.45 g/dL; 95% CI, 0.08-0.83; P = .02) and ferritin levels (MD, 37.32 ng/mL; 95% CI, 18.98-55.65; P <.01) compared to IS.1

Additionally, they found that FCM was associated with a higher risk of hypersensitivity reactions compared to IS (relative risk [RR], 2.97; 95% CI: 1.35-6.52, P <.01) but not with severe adverse events (AE; RR, 1.03; 95% CI, 0.88-1.21; P = .70). They also found a nonsignificant increased risk of hypophosphatemia (RR, 2.84; 95% CI, 0.89-9.06; P = .08).1

The investigators also looked at FCM’s efficacy stratified by subgroups and found that FCM yielded a statistically significant improvement in Hb levels in patients with postpartum anemia (MD, 1.04 g/dL; 95% CI, 0.75-1.33; P <.01) but was statistically less effective for patients with hemodialysis (MD, -0.24 g/dL; 95% CI, -0.53-0.04; P < .01) when compared to IS.1

“Ten studies showed some concerns of risk of bias, and four studies had a high risk of bias for the change in hemoglobin levels during follow-up. Lack of standardized definitions for hypersensitivity reactions and variability in dosing protocols and follow-up durations across studies may affect the generalizability of our safety findings,” Tanrıverdi and colleagues wrote.1

The investigators used a graphical funnel plot to evaluate bias. They noted limitations of the study, including a lack of reported data on key safety outcomes, such as hypophosphatemia, as well as standardized definitions for serious or severe AEs or hypersensitivity, which may limit the generalizability of their findings. Other variability in factors across studies may also have influenced the observed treatment effects.

REFERENCES

1. Tanriverdi LH, Sarici A. Efficacy, Safety, and Tolerability of Ferric Carboxymaltose and Iron Sucrose in Iron Deficiency Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Turk J Haematol. Published online March 17, 2025. doi:10.4274/tjh.galenos.2025.2025.0034

2. Shin HW, Go DY, Lee SW, Choi YJ, Ko EJ, You HS, Jang YK. Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis. Medicine (Baltimore). 2021;100(20):e24571