Efficacy and safety of ferric derisomaltose (FDI) compared with iron sucrose (IS) in patients with iron deficiency anemia after bariatric surgery

Maureen M. Achebe,Michael Auerbach,Richard J. Derman,Lars L. Thomsen

doi:10.1007/s11695-021-05858-0

Abstract

PurposeIron deficiency is common following bariatric surgery, and treatment with intravenous iron is often required. This post hoc analysis of data from two randomized, open-label, multicenter trials evaluated the efficacy and safety of ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS) over 4 weeks in adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery.Materials and methodsData were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery. Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia.ResultsThe analysis included 159 patients. Mean (standard deviation) cumulative iron doses were 1199 (± 347) mg for FDI and 937 (± 209) mg for IS. Compared with IS, FDI resulted in a faster and more pronounced Hb response, and a higher proportion of responders (Hb level increase ≥ 2 g/dL from baseline) at all time points. The incidence of ADRs was similar with FDI and IS (15.1% and 18.2%, respectively), with no serious ADRs or serious or severe HSRs reported. The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed.ConclusionsIn patients with IDA resulting from bariatric surgery, FDI produced a faster and more pronounced Hb response than IS. Both FDI and IS were well tolerated.Graphical abstract

Highlights

Iron deficiency (ID) is a common cause of anemia following bariatric surgery [1, 2], especially after Roux-en-Y gastric bypass (RYGB), which restricts food intake and nutrient absorption [3,4,5]
All analyses were performed using safety analysis set (SAS) software. This pooled analysis included a total of 159 patients with iron deficiency anemia (IDA) occurring after bariatric surgery: 93 received ferric derisomaltose (FDI) and 66 iron sucrose (IS)
Baseline characteristics were comparable among the treatment groups, s-ferritin and transferrin saturation (TSAT) levels were numerically higher in the FDI group compared with the IS group

Summary

Introduction

Iron deficiency (ID) is a common cause of anemia following bariatric surgery [1, 2], especially after Roux-en-Y gastric bypass (RYGB), which restricts food intake and nutrient absorption [3,4,5]. Multiple factors are associated with the development of ID post bariatric surgery, including a reduction in the surface area available for iron absorption (due to decreased stomach capacity and bypass of the duodenum), an inadequate intake of dietary iron (due to a low tolerance of red meat), and reduced gastric acid secretion [2, 4, 7, 8]. ID can have a considerable impact on an individual’s health, when the deficiency results in anemia.

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