Background: Iron deficiency anemia is highly prevalent in patients with chronic kidney disease and is often treated\nwith intravenous iron. There are few trials directly comparing the safety and efficacy of different intravenous iron\nproducts.\nMethods: This post-hoc analysis pooled data from 767 patients enrolled in two randomized, controlled, open-label\ntrials of similar design comparing the treatment of iron deficiency anemia with ferumoxytol and iron sucrose across\npatients with all stages of renal function. One trial was conducted in adults with CKD either on or not on dialysis\nand the second in adults with IDA of any underlying cause and a history of unsatisfactory oral iron therapy or in\nwhom oral iron could not be used who had normal to no worse than moderately impaired renal function. Patients\nwere categorized by chronic kidney disease stage (i.e., estimated glomerular filtration rate), and the primary efficacy\nendpoint was the mean change in hemoglobin from Baseline to Week 5.\nResults: The overall incidence of adverse events was numerically lower in ferumoxytol-treated patients compared\nto those treated with iron sucrose (42.4 vs. 50.2 %, respectively); the incidence of treatment-related adverse events\nwas generally similar between the two treatment groups (13.6 vs. 16.0 %, respectively). Adverse events of Special\nInterest (i.e., hypotension, hypersensitivity) occurred at lower rates in those treated with ferumoxytol compared to\nthose treated with iron sucrose (2.5 vs. 5.3 %, respectively). Overall, mean hemoglobin increased in both treatment\ngroups, regardless of degree of renal insufficiency, although greater increases were seen among those with less\nsevere kidney damage. Mean increases in hemoglobin from Baseline to Week 5 were significantly greater with\nferumoxytol than with iron sucrose treatment in the subgroup with an estimated glomerular filtration rate �90 mL/min\n(Least Squares mean difference = 0.53 g/dL; p < 0.001). There were no other consistent, significant differences in\nhemoglobin levels between treatment groups for the other chronic kidney disease categories except for isolated\ninstances favoring ferumoxytol.\nConclusions: The efficacy and safety of ferumoxytol is at least comparable to iron sucrose in patients with varying\ndegrees of renal function.
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