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

Agüera ML, Martin-Malo A, Alvarez-Lara MA, Garcia-Montemayor VE, Canton P, Soriano S, Aljama P - PLoS ONE (2015)

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: 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.

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.

No MeSH data available.


Related in: MedlinePlus

Distribution of the population depending on ERI (4A) or TSAT levels (4B).
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pone.0135967.g004: Distribution of the population depending on ERI (4A) or TSAT levels (4B).

Mentions: The mean ERI level was 8.4±7.7 IU/kg/week/g per 100ml during the Generic period versus 7.4±6.7 IU/kg/week/g per 100ml during the Original period (p = 0.001), which constituted a 12% decrease. Based on the ERI level, the study population was divided into 3 groups: <5; between 5 and 15; and >15 (Fig 4A). 15.8% of patients had an ERI>15 during the Generic period compared with 10.7% during the Original period (p<0.001).


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

Agüera ML, Martin-Malo A, Alvarez-Lara MA, Garcia-Montemayor VE, Canton P, Soriano S, Aljama P - PLoS ONE (2015)

Distribution of the population depending on ERI (4A) or TSAT levels (4B).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4555833&req=5

pone.0135967.g004: Distribution of the population depending on ERI (4A) or TSAT levels (4B).
Mentions: The mean ERI level was 8.4±7.7 IU/kg/week/g per 100ml during the Generic period versus 7.4±6.7 IU/kg/week/g per 100ml during the Original period (p = 0.001), which constituted a 12% decrease. Based on the ERI level, the study population was divided into 3 groups: <5; between 5 and 15; and >15 (Fig 4A). 15.8% of patients had an ERI>15 during the Generic period compared with 10.7% during the Original period (p<0.001).

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: 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.

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.

No MeSH data available.


Related in: MedlinePlus