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 .
Maintenance of elevated versus physiological iron indices in non-anaemic patients with chronic kidney disease: a randomized controlled trial.
BACKGROUND An optimal haemoglobin ( Hb ) response to erythropoietin requires elevated iron indices in dialysis patients ; however , it is unknown if the same applies in chronic kidney disease ( CKD ) . METHODS One hundred patients [ CKD Stages 3 - 5 , Hb > or= 110 g/L , iron replete , erythropoietin-stimulating agent (ESA)-naive , 47 % diabetic , median age 69.5 years ] were block-r and omized in an open-label study to receive up to 200 mg intravenous iron sucrose ( Group A , n = 52 ) bimonthly or oral iron sulphate ( Group B ) to maintain raised and normal iron indices ( respectively ) over 12 months . The primary endpoint was the change in Hb concentration at 12 months or at termination after at least 6 months of treatment . RESULTS Eighty-five patients reached the primary endpoint ( 43 , Group A ; 42 , Group B ) . Initial Hb was 119 + /- 7 vs 116 + /- 12 g/L ( mean + /- st and ard deviation ) ; ferritin 122 ( 71 - 176 ) , median ( inter-quartile range ) , vs 90 microg/L ( 58 - 150 ) ; transferrin saturation ( TSat ) 22 ( 18 - 26 ) vs 21 % ( 15 - 24 ) ; and creatinine 240 ( 195 - 313 ) vs 230 micromol/L ( 184 - 352 ) . Ferritin and TSat differed by month 2 [ 157 ( 103 - 220 ) vs 96 microg/L ( 73 - 162 ) , P = 0.003 ] and month 6 [ 25 ( 20 - 31 ) vs 21 % ( 17 - 27 ) , P = 0.02 ] , respectively . At study end , Hb did not differ between groups ( 121 + /- 10 vs 117 + /- 13 g/L ) . Ferritin was 362 ( 310 - 458 ) vs 125 microg/L ( 84 - 190 ) , P < 0.001 ; TSat 30 ( 23 - 34 ) vs 21 % ( 18 - 24 ) , P < 0.001 ; and creatinine 229 ( 188 - 326 ) vs 272 micromol/L ( 195 - 413 ) , P = NS . For patients ( Groups A and B , n = 27 in each group ) whose creatinine regression slope increased ( indicating worsening function ) , the fall in Hb over 12 months also did not differ between groups despite adequate separation in iron indices . Serious adverse events overall did not differ between groups . CONCLUSIONS Elevated iron indices did not increase Hb synthesis in ESA-naive , iron replete , pre-dialysis patients with Hb > 110
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 .