title: Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin.
abstract: The Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study demonstrated the efficacy of intravenous ferric gluconate to improve hemoglobin levels in anemic hemodialysis patients who were receiving adequate epoetin doses and who had ferritin levels between 500 and 1200 ng/ml and transferrin saturation (TSAT) < or = 25%. The DRIVE-II study reported here was a 6-wk observational extension designed to investigate how ferric gluconate impacted epoetin dosage after DRIVE. During DRIVE-II, treating nephrologists and anemia managers adjusted doses of epoetin and intravenous iron as clinically indicated. By the end of observation, patients in the ferric gluconate group required significantly less epoetin than their DRIVE dose (mean change of -7527 +/- 18,021 IU/wk, P = 0.003), whereas the epoetin dose essentially did not change for patients in the control group (mean change of 649 +/- 19,987 IU/wk, P = 0.809). Mean hemoglobin, TSAT, and serum ferritin levels remained higher in the ferric gluconate group than in the control group (P = 0.062, P < 0.001, and P = 0.014, respectively). Over the entire 12-wk study period (DRIVE plus DRIVE-II), the control group experienced significantly more serious adverse events than the ferric gluconate group (incidence rate ratio = 1.73, P = 0.041). In conclusion, ferric gluconate maintains hemoglobin and allows lower epoetin doses in anemic hemodialysis patients with low TSAT and ferritin levels up to 1200 ng/ml.
authors.affiliation: Department of Medicine, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, USA. tkapoian@verizon.net
authors.forename: Toros
authors.initials: T
authors.lastname: Kapoian
authors.forename: Neeta B
authors.initials: NB
authors.lastname: O'Mara
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Singh
authors.forename: John
authors.initials: J
authors.lastname: Moran
authors.forename: Adel R
authors.initials: AR
authors.lastname: Rizkala
authors.forename: Robert
authors.initials: R
authors.lastname: Geronemus
authors.forename: Robert C
authors.initials: RC
authors.lastname: Kopelman
authors.forename: Naomi V
authors.initials: NV
authors.lastname: Dahl
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Coyne
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D005293:Ferritins / Q000097:blood; D006397:Hematinics / Q000008:administration & dosage*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007275:Injections, Intravenous; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D006435:Renal Dialysis; D014168:Transferrin / Q000378:metabolism
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D014168:Transferrin; D004921:Erythropoietin; D005293:Ferritins; C035552:ferric gluconate