title: Safety and efficacy of sodium ferric gluconate complex in patients with chronic kidney disease.
abstract: BACKGROUND
  We hypothesized that intravenous iron will improve hemoglobin (Hgb) concentrations in anemic patients with chronic kidney disease (CKD), and the response would be greater if the underlying erythropoietin deficiency also was treated.
  
  
  METHODS
  Charts of 58 CKD veterans (glomerular filtration rate < 80 mL/min) administered at least 125 mg of sodium ferric gluconate complex in sucrose (SFGC) during a period of 1 year for the primary outcome of an increase in Hgb level by at least 0.5 g/dL were reviewed.
  
  
  RESULTS
  Mean Hgb level at baseline was 10.5 +/- 1.4 (SD) g/dL (105 +/- 14 g/L) in the 30 patients administered recombinant human erythropoietin (rHuEPO) plus SFGC and 10.1 +/- 1.3 g/dL (101 +/- 13 g/L) in the 28 patients administered SFGC alone (P = not significant). The primary event occurred in 83% of the rHuEPO-plus-SFGC group at 31 days compared with 60% at 62 days in the group administered SFGC alone (P = 0.037, Cox F test). In patients administered SFGC alone, mean maximal Hgb level was 11.4 +/- 0.9 g/dL (114 +/- 9 g/L) in contrast to 12.4 +/- 1.7 g/dL (124 +/- 17 g/L) in the combination group, which remained significantly different even after adjustment for biologically important covariates (P = 0.01, analysis of covariance). Of the 240 doses of SFGC administered for which infusion records were available, 237 doses were well tolerated; three hypotensive episodes occurred in 2 patients, which did not result in discontinuation of the drug in either case.
  
  
  CONCLUSIONS
  Correction of anemia with parenteral iron alone suggests a high prevalence of iron deficiency in patients with CKD. Treatment of concomitant iron deficiency with SFGC was well tolerated in patients with CKD and appears to optimize management of anemia.
authors.affiliation: Richard L. Roudebush Veterans Affairs Medical Center, and Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Atinder
authors.initials: A
authors.lastname: Panesar
authors.forename: Rajiv
authors.initials: R
authors.lastname: Agarwal
mesh_terms: D000284:Administration, Oral; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy; D016303:Clinical Pharmacy Information Systems; D019992:Databases as Topic; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007501:Iron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000188:drug therapy*; D008297:Male; D008499:Medical Records; D011994:Recombinant Proteins; D012189:Retrospective Studies; D013395:Sucrose / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014728:Veterans
chemical_list: D005290:Ferric Compounds; D011994:Recombinant Proteins; D004921:Erythropoietin; D013395:Sucrose; D007501:Iron; C035552:ferric gluconate