Maria Luisa Agüera1, Alejandro Martin-Malo1, Maria Antonia Alvarez-Lara1, Victoria Eugenia Garcia-Montemayor2, Petra Canton2, Sagrario Soriano1, Pedro Aljama1
1Servicio 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, 2 Dialysis Unit, SOCODI SL, Córdoba, Spain
Abstract
Aims
The appropriate use of intravenous (IV) iron is essential to minimise the requirements for erythropoiesis-stimulating agents (ESAs). The clinical efficacy of generic IV iron compared to the original formulation is controversial. We evaluated the changes that were induced after switching from a generic IV 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 IV iron were prospectively recorded before and after the switch from generic to original IV iron.
Results
To maintain the same haemoglobin (Hb) levels after switching from the generic to the original formulation, the requirements for IV iron doses were reduced by 34.3% (from 52.8±33.9 to 34.7±31.8mg/week, p<0.001), and the ESA doses were also decreased by 12.5% (from 30.6±23.6 to 27±21μg/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 IV 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 IV iron. Further studies are necessary to analyse the adverse effects of higher IV iron dosages.
(Reference link : http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0135967)
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Nephrol Dial Transplant ,February 25, 2011
Do two intravenous iron sucrose preparations have the same efficacy?
Jacques Rottembourg1, Ahmed Kadri1, Emmanuelle Leonard1, Aurelie Dansaert1 and Antoine Lafuma2
1Centre Suzanne Levy, Groupe Diaverum, Paris, France and 2Cemka/Eval, Bourg La Reine, France
Abstract
Background
Intravenous (i.v.) iron sucrose similar (ISS) preparations are available but clinical comparisons with the originator iron sucrose (IS) are lacking.
Methods
The impact of switching from IS to ISS on anaemia and iron parameters was assessed in a sequential observational study comparing two periods of 27 weeks each in 75 stable haemodialysis (HD) patients receiving i.v. iron weekly and an i.v. erythropoiesis-stimulating agent (ESA) once every 2 weeks. Patients received IS in the first period (P1) and ISS in the second period (P2).
Results
Mean haemoglobin value was 11.78 ± 0.99 g/dL during P1 and 11.48 ± 0.98 g/dL during P2 (P = 0.01). Mean serum ferritin was similar for both treatment periods (P1, 534 ± 328 μg/L; P2, 495 ± 280 lg/L, P = 0.25) but mean TSAT during P1 (49.3 ± 10.9%) was significantly higher than during P2 (24.5 ± 9.4%, P < 0.0001). The mean dose of i.v. iron per patient per week was 45.58 ± 32.55 mg in P1 and 61.36 ± 30.98 mg in P2 (+34.6%), while the mean ESA dose was 0.58 ± 0.52 and 0.66 ± 0.64 μg/kg/week, respectively (+13.8%). Total mean anaemia drug costs increased in P2 by 11.9% compared to P1.
Conclusions
The switch from the originator IS to an ISS preparation led to destabilization of a well-controlled population of HD patients and incurred an increase in total anaemia drug costs. Prospective comparative clinical studies are required to prove that ISS are as efficacious and safe as the originator i.v. IS.
(Reference link : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193183/ )
