High-dose parenteral iron does not seem to be associated with higher risk of infection , all-cause mortality , increased hospitalization or increased cardiovascular events on analysis of RCTs .
Observational studies show increased risk for all-cause mortality , infections and hospitalizations that were not statistically significant and were associated with significant heterogeneity
Parental iron is used to optimize hemoglobin and enhance erythropoiesis in end-stage renal disease along with erythropoietin-stimulating agents .
Safety of iron has been debated extensively and there is no definite evidence whether parenteral iron increases the risk of infections and mortality .
We performed this meta- analysis to evaluate the incidence of infectious complications , hospitalizations and mortality with use of parenteral iron .
Ferric pyrophosphate citrate (Triferic™) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients
Background Administration of ferric pyrophosphate citrate ( FPC , Triferic ™ ) via hemodialysate may allow replacement of ongoing uremic and hemodialysis-related iron losses . FPC donates iron directly to transferrin , bypassing the reticuloendothelial system and avoiding iron sequestration . Methods Two identical Phase 3 , r and omized , placebo-controlled trials ( CRUISE 1 and 2 ) were conducted in 599 iron-replete chronic hemodialysis patients . Patients were dialyzed with dialysate containing 2 µM FPC-iron or st and ard dialysate ( placebo ) for up to 48 weeks . Oral or intravenous iron supplementation was prohibited , and doses of erythropoiesis-stimulating agents were held constant . The primary efficacy end point was the change in hemoglobin ( Hgb ) concentration from baseline to end of treatment ( EoT ) . Secondary end points included reticulocyte hemoglobin content ( CHr ) and serum ferritin . Results In both trials , Hgb concentration was maintained from baseline to EoT in the FPC group but decreased by 0.4 g/dL in the placebo group ( P < 0.001 , combined results ; 95 % confidence interval [ CI ] 0.2–0.6 ) . Placebo treatment result ed in significantly larger mean decreases from baseline in CHr ( −0.9 pg versus −0.4 pg , P < 0.001 ) and serum ferritin ( −133.1 µg/L versus −69.7 µg/L , P < 0.001 ) than FPC treatment . The proportions of patients with adverse and serious adverse events were similar in both treatment groups . Conclusions FPC delivered via dialysate during hemodialysis replaces iron losses , maintains Hgb concentrations , does not increase iron stores and exhibits a safety profile similar to placebo . FPC administered by hemodialysis via dialysate represents a paradigm shift in delivering maintenance iron therapy to hemodialysis patients
High-dose parenteral iron does not seem to be associated with higher risk of infection , all-cause mortality , increased hospitalization or increased cardiovascular events on analysis of RCTs .
Observational studies show increased risk for all-cause mortality , infections and hospitalizations that were not statistically significant and were associated with significant heterogeneity
Parental iron is used to optimize hemoglobin and enhance erythropoiesis in end-stage renal disease along with erythropoietin-stimulating agents .
Safety of iron has been debated extensively and there is no definite evidence whether parenteral iron increases the risk of infections and mortality .
We performed this meta- analysis to evaluate the incidence of infectious complications , hospitalizations and mortality with use of parenteral iron .