Ferric Derisomaltose Compared to Iron Sucrose in Iron Deficiency Anemia: A Meta-Analysis of Randomized Controlled Trials.

Background/

Objectives

There are conflicting results on the effects of ferric derisomaltose (FDM) vs. iron sucrose (IS) for treatment of iron deficiency anemia (IDA). We systematically assessed the efficacy and safety of these treatments.

Methods

We searched Ovid MEDLINE, Web of Science, Pubmed, and Cochrane Central for randomized controlled trials (RCTs) comparing the efficacy and/or safety of FDM vs. IS in patients with IDA. The primary efficacy outcome was the change in hemoglobin (Hb) levels at week 4, and the safety outcome was serious or severe hypersensitivity reactions, as defined by a standardized set of Medical Dictionary for Regulatory Activities (MedDRA) terms. Inverse-variance random effects models were used for meta-analyses.

Results

Five RCTs were included: two in general IDA (n = 1994), two in non-dialysis chronic kidney disease (n = 1542), and one in hemodialysis patients (n = 344). The evidence was very uncertain about the effect of FDM vs. IS for Hb change at week 4 (mean difference [MD] 0.09 g/dL, 95% CI -0.33 to 0.52; I2 = 84%, very low CoE), serious or severe hypersensitivity reactions (MedDRA A + B + C + D, relative risk [RR] 0.83, 95% CI 0.25 to 2.68; I2 = 0%, very low CoE), Hb change at week 8 (MD 0.04 g/dL, 95% CI -0.08 to 0.15; I2 = 0%, very low CoE), Hb increase of ≥2 g/dL at week 4 (RR 1.16, 95% CI 0.97 to 1.38; I2 = 70%, very low CoE), and anaphylactic reactions (MedDRA A, RR 0.38, 95% CI 0.08 to 1.72; I2 = 0%, very low CoE).

Conclusions

We found that FDM vs. IS had little to no effect on outcomes for the treatment of IDA.