There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .
Phase III, randomized study of the effects of parenteral iron, oral iron, or no iron supplementation on the erythropoietic response to darbepoetin alfa for patients with chemotherapy-associated anemia.
PURPOSE Functional iron deficiency may impair response to erythropoiesis-stimulating agents ( ESAs ) in iron-replete patients with chemotherapy-associated anemia ( CAA ) . This study evaluated whether coadministration of parenteral iron improves ESA efficacy in patients with CAA . PATIENTS AND METHODS This prospect i ve , multicenter , r and omized trial enrolled 502 patients with hemoglobin ( Hb ) less than 11 g/dL who were undergoing chemotherapy for nonmyeloid malignancies . All patients received darbepoetin alfa once every 3 weeks and were r and omly assigned to receive either ferric gluconate 187.5 mg intravenously ( IV ) every 3 weeks , oral daily ferrous sulfate 325 mg , or oral placebo for 16 weeks . RESULTS There was no difference in the erythropoietic response rate ( ie , proportion of patients achieving Hb ≥ 12 g/dL or Hb increase ≥ 2 g/dL from baseline ) : 69.5 % ( 95 % CI , 61.9 % to 76.5 % ) of IV iron-treated patients achieved an erythropoietic response compared with 66.9 % ( 95 % CI , 59.1 % to 74.0 % ) who received oral iron and 65.0 % ( 95 % CI , 57.2 % to 72.3 % ) who received oral placebo ( P = .75 ) . There were also no differences in the proportion of patients requiring red cell transfusions , changes in quality of life , or the dose of darbepoetin administered . Adverse events ( AEs ) tended to be more common in the IV iron arm : grade 3 or higher AEs occurred in 54 % ( 95 % CI , 46 % to 61 % ) of patients receiving IV iron compared with 44 % ( 95 % CI , 36 % to 52 % ) who received oral iron and 46 % ( 95 % CI , 38 % to 54 % ) who received oral placebo ( P = .16 ) . CONCLUSION In patients with CAA , addition of IV ferric gluconate to darbepoetin failed to provide additional benefit compared with oral iron or oral placebo
There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .