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. 2015 Aug 31;10(8):e0135967.
doi: 10.1371/journal.pone.0135967. eCollection 2015.

Efficiency of Original versus Generic Intravenous Iron Formulations in Patients on Haemodialysis

Maria Luisa Agüera  1 , Alejandro Martin-Malo  1 , Maria Antonia Alvarez-Lara  1 , Victoria Eugenia Garcia-Montemayor  2 , Petra Canton  2 , Sagrario Soriano  1 , Pedro Aljama  1
Affiliations

Efficiency of Original versus Generic Intravenous Iron Formulations in Patients on Haemodialysis

Maria Luisa Agüera et al. PLoS One. .

Abstract

Aims: 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.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Study design (1A) and algorithm of study population selection (1B).
Fig 2
Fig 2. Haemoglobin, intravenous iron and darbepoetin doses in each period (2A) and monthly (2B).
Fig 3
Fig 3. Variability in haemoglobin in each period (3A) and in quarterly (3B).
Fig 4
Fig 4. Distribution of the population depending on ERI (4A) or TSAT levels (4B).
See this image and copyright information in PMC

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