title: Efficiency of Original versus Generic Intravenous Iron Formulations in Patients on Haemodialysis.
abstract: OBJECTIVE
  The appropriate use of intravenous (i.v.) iron is essential to minimise the requirements for erythropoiesis-stimulating agents (ESAs). The clinical efficacy of generic i.v. iron compared to the original formulation is controversial. We evaluated the changes that were induced after switching from a generic i.v. iron to an original formulation in a stable, prevalent haemodialysis (HD) population.
  
  
  METHODS
  A total of 342 patients were included, and the follow-up period was 56 weeks for each formulation. Anaemia parameters and doses of ESA and i.v. iron were prospectively recorded before and after the switch from generic to original i.v. iron.
  
  
  RESULTS
  To maintain the same haemoglobin (Hb) levels after switching from the generic to the original formulation, the requirements for i.v. iron doses were reduced by 34.3% (from 52.8±33.9 to 34.7±31.8 mg/week, p<0.001), and the ESA doses were also decreased by 12.5% (from 30.6±23.6 to 27±21 μg/week, p<0.001). The erythropoietin resistance index declined from 8.4±7.7 to 7.4±6.7 IU/kg/week/g/dl after the switch from the generic to the original drug (p = 0.001). After the switch, the transferrin saturation ratio (TSAT) and serum ferritin levels rose by 6.8% (p<0.001) and 12.4% (p = 0.001), respectively. The mortality rate was similar for both periods.
  
  
  CONCLUSIONS
  The iron and ESA requirements are lower with the original i.v. iron compared to the generic drug. In addition, the uses of the original formulation results in higher ferritin and TSAT levels despite the lower dose of i.v. iron. Further studies are necessary to analyse the adverse effects of higher i.v. iron dosages.
authors: Servicio de Nefrología. Hospital Universitario Reina Sofía, Córdoba, Spain; Instituto Maimónides de investigación biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain; RedInRen, Instituto de salud Carlos III, Spain.
authors: Maria Luisa
authors: ML
authors: Agüera
authors: Servicio de Nefrología. Hospital Universitario Reina Sofía, Córdoba, Spain; Instituto Maimónides de investigación biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain; RedInRen, Instituto de salud Carlos III, Spain.
authors: Alejandro
authors: A
authors: Martin-Malo
authors: Servicio de Nefrología. Hospital Universitario Reina Sofía, Córdoba, Spain; Instituto Maimónides de investigación biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain; RedInRen, Instituto de salud Carlos III, Spain.
authors: Maria Antonia
authors: MA
authors: Alvarez-Lara
authors: Dialysis Unit, SOCODI SL, Córdoba, Spain.
authors: Victoria Eugenia
authors: VE
authors: Garcia-Montemayor
authors: Dialysis Unit, SOCODI SL, Córdoba, Spain.
authors: Petra
authors: P
authors: Canton
authors: Servicio de Nefrología. Hospital Universitario Reina Sofía, Córdoba, Spain; Instituto Maimónides de investigación biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain; RedInRen, Instituto de salud Carlos III, Spain.
authors: Sagrario
authors: S
authors: Soriano
authors: Servicio de Nefrología. Hospital Universitario Reina Sofía, Córdoba, Spain; Instituto Maimónides de investigación biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain; RedInRen, Instituto de salud Carlos III, Spain.
authors: Pedro
authors: P
authors: Aljama
mesh_terms: D061605:Administration, Intravenous / Q000379:methods; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy / Q000378:metabolism; D002626:Chemistry, Pharmaceutical / Q000379:methods; D016568:Drugs, Generic / Q000008:administration & dosage*; D004921:Erythropoietin / Q000378:metabolism; D005260:Female; D005293:Ferritins / Q000097:blood; D005500:Follow-Up Studies; D006397:Hematinics / Q000008:administration & dosage; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007501:Iron / Q000008:administration & dosage*; D008297:Male; D011446:Prospective Studies; D006435:Renal Dialysis / Q000401:mortality*; D014168:Transferrin / Q000378:metabolism
chemical_list: D016568:Drugs, Generic; D006397:Hematinics; D006454:Hemoglobins; D014168:Transferrin; D004921:Erythropoietin; D005293:Ferritins; D007501:Iron