A Randomized Comparison of Ferumoxytol and Iron Sucrose for Treating Iron Deficiency Anemia in Patients with CKD

Abstract

Background and objectives Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia. This study compared the efficacy and safety of two intravenous iron products (ferumoxytol [Feraheme injection] and iron sucrose [Venofer]) in patients with CKD and iron deficiency anemia.Design, setting, participants, & measurements In this phase II, randomized, open-label, active-controlled, multicenter clinical trial, patients were randomized 1:1 to either 1.02 g ferumoxytol (23510-mg injections) or 1.0 g iron sucrose administered as either a slow injection or infusion (10 doses for dialysis patients and 5 doses for nondialysis patients). Inclusion criteria included hemoglobin,11.0 g/dl, transferrin saturation,30%, and eGFR,60 ml/min per 1.73 m 2 or a diagnosis of underlying CKD (e.g., nephropathy or nephritis). The primary end point was change in hemoglobin from baseline to week 5. ResultsIn total, 162 patients were randomized. Demographics were balanced between the treatment groups. Adverse event profiles of the two regimens were fairly similar: overall adverse events, 48% ferumoxytol versus 65% iron sucrose; related adverse events, 10% ferumoxytol versus 16% iron sucrose; and adverse events leading to study discontinuation, 1% ferumoxytol versus 5% iron sucrose. Rates of serious adverse events and related serious adverse events were similar between the ferumoxytol and iron sucrose groups: serious adverse events, 9% versus 7%, respectively and related serious adverse events, 1% versus 1%, respectively. Overall, increases in hemoglobin were similar between treatment groups. Based on an ANOVA model adjusted for baseline hemoglobin level and dialysis status, the least squares mean change from baseline to week 5 was 0.860.1 g/dl in the ferumoxytol-treated group and 0.760.1 g/dl in the iron sucrose group. The difference in the mean change from baseline between the two treatment groups was 0.1 g/dl (95% confidence interval, 20.2 to 0.4). ConclusionIn this randomized, controlled trial, ferumoxytol and iron sucrose showed comparable efficacy and adverse events rates.

How we diagnose and treat iron deficiency anemia

“…The authors concluded that when HMW iron dextran is avoided, the other formulations are safe with a SAE rate of less than 1:200,000 administrations [43]. This is supported by two published prospective studies and a meta-analysis comparing LMW iron dextran and IS [44][45][46], two prospective comparisons of ferumoxytol and IS [47,48], and a retrospective observational analysis [49], all of which found no significant difference in adverse events among the various formulations. Consistent with these data, Wysoski et al, using the IMS Database (a pharmaceutical marketing research company whose data are based on sales of products moving from manufacturers into various outlets), FDA reporting system MedWatch, emergency room visits and death certificates obtained from the National Center for Health Statistics, concluded it is impossible, using current monitoring systems, to tell the relative rates of SAEs absent head-to-head trials [50].…”

On the safety of intravenous iron, evidence trumps conjecture

“…11 The only prospective trial to report a significant safety difference between any of the formulations compared the now unavailable HMWID to ferric carboxymaltose and erroneously concluded, without differentiating the high and low molecular weight formulations, that ferric carboxymaltose had a safety advantage over iron dextran.…”

“…If minor infusion reactions occur with one formulation, switching to another is appropriate and safe. Christian Breymann, 4 Steven Fishbane, 5 Anat Gafter-Gvili, 6 Christoph Gasche, 7 Jeffrey Gilreath, 8 Giuliano Grazzini, 9 David Henry, 10 Giancarlo Liumbruno, 11 Francesco Locatelli, 12 Iain Macdougall, 13 Manuel Munoz, 14 David Rampton, 15 George Rodgers, 16 and Aryeh Shander …”

Anemia; To Determine the Efficacy of Erythropoiten in Correction of Heamoglobin

“…Macrocytic is when MCV >91 fl. 18 In microcytic aneamia, serum iron is decreased and total iron binding capacity (TIBC) is increased. The serum ferritin level indicates iron stores in the body.…”