Switching iron sucrose to ferric carboxymaltose associates to better control of iron status in hemodialysis patients

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Abstract

Background

Although the efficacy of iron sucrose (IS) and ferric carboxymaltose (FCM) in treating anemia in hemodialysis (HD) patients has been studied individually, a comparison of these two intravenous iron formulations has not yet been performed in HD patients.

Methods

We performed a retrospective audit on records of 221 stable HD patients from different HD centers in the Netherlands, who were switched from IS to FCM on a 1:1 ratio. To assess the effect of the switch on iron status parameters, data from 3 time points before and 3 time points after the switch were analyzed using linear mixed effects models. Subanalyses were done in 2 subgroups of patients anemic or iron deficient at baseline.

Results

Hemoglobin increased in all groups (anemic [1.4 g/dL, P < 0.001] iron deficient [0.6 g/dL, P < 0.001]), while the weekly iron dose was significantly lower when patients received FCM compared to IS (48 vs 55 mg/week, P = 0.04). Furthermore, serum ferritin and transferrin saturation increased in all groups (anemic [64 μg/L, 5.0%, P < 0.001] iron deficient [76 μg/L, 3.6%, P < 0.001]). Finally, the darbepoetin α dose decreased significantly in all groups (anemic [− 16 μg/wk., P = 0.01] iron deficient [− 11 μg/wk., P < 0.001]).

Conclusions

In this real-life study in HD patients, a switch from IS to FCM resulted in an improvement of iron status parameters despite a lower weekly dose of FCM. Furthermore, the ESA dose was reduced during FCM, while hemoglobin levels increased.

Electronic supplementary material

The online version of this article (10.1186/s12882-018-1045-8) contains supplementary material, which is available to authorized users.

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FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease.

Igor L Khalif, Florian Gutzwiller, Philippe Marteau … (2011)

Iron deficiency anemia (IDA) is common in chronic diseases and intravenous iron is an effective and recommended treatment. However, dose calculations and inconvenient administration may affect compliance and efficacy. We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen (FCM) with individually calculated iron sucrose (IS) doses in patients with inflammatory bowel disease (IBD) and IDA. This randomized, controlled, open-label, multicenter study included 485 patients with IDA (ferritin <100 μg/L, hemoglobin [Hb] 7-12 g/dL [female] or 7-13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries. Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron. Primary end point was Hb response (Hb increase ≥ 2 g/dL); secondary end points included anemia resolution and iron status normalization by week 12. The results of 240 FCM-treated and 235 IS-treated patients were analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 118 [53.6%]; 12.2% difference, P = .004) or Hb normalization (166 [72.8%] vs 136 [61.8%]; 11.0% difference, P = .015). Both treatments improved quality of life scores by week 12. Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience. Deviations from scheduled total iron dosages were more frequent in the IS group. The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen. Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

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FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia

Iain C. MacDougall, Andreas H. Bock, Fernando Carrera … (2014)

Background The optimal iron therapy regimen in patients with non-dialysis-dependent chronic kidney disease (CKD) is unknown. Methods Ferinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease (FIND-CKD) was a 56-week, open-label, multicentre, prospective and randomized study of 626 patients with non-dialysis-dependent CKD, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents (ESAs). Patients were randomized (1:1:2) to intravenous (IV) ferric carboxymaltose (FCM), targeting a higher (400–600 µg/L) or lower (100–200 µg/L) ferritin or oral iron therapy. The primary end point was time to initiation of other anaemia management (ESA, other iron therapy or blood transfusion) or haemoglobin (Hb) trigger of two consecutive values <10 g/dL during Weeks 8–52. Results The primary end point occurred in 36 patients (23.5%), 49 patients (32.2%) and 98 patients (31.8%) in the high-ferritin FCM, low-ferritin FCM and oral iron groups, respectively [hazard ratio (HR): 0.65; 95% confidence interval (CI): 0.44–0.95; P = 0.026 for high-ferritin FCM versus oral iron]. The increase in Hb was greater with high-ferritin FCM versus oral iron (P = 0.014) and a greater proportion of patients achieved an Hb increase ≥1 g/dL with high-ferritin FCM versus oral iron (HR: 2.04; 95% CI: 1.52–2.72; P < 0.001). Rates of adverse events and serious adverse events were similar in all groups. Conclusions Compared with oral iron, IV FCM targeting a ferritin of 400–600 µg/L quickly reached and maintained Hb level, and delayed and/or reduced the need for other anaemia management including ESAs. Within the limitations of this trial, no renal toxicity was observed, with no difference in cardiovascular or infectious events. ClinicalTrials.gov number NCT00994318.

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The Pharmacokinetics and Pharmacodynamics of Iron Preparations

Peter Geisser, Susanna Burckhardt (2011)

Standard approaches are not appropriate when assessing pharmacokinetics of iron supplements due to the ubiquity of endogenous iron, its compartmentalized sites of action, and the complexity of the iron metabolism. The primary site of action of iron is the erythrocyte, and, in contrast to conventional drugs, no drug-receptor interaction takes place. Notably, the process of erythropoiesis, i.e., formation of new erythrocytes, takes 3–4 weeks. Accordingly, serum iron concentration and area under the curve (AUC) are clinically irrelevant for assessing iron utilization. Iron can be administered intravenously in the form of polynuclear iron(III)-hydroxide complexes with carbohydrate ligands or orally as iron(II) (ferrous) salts or iron(III) (ferric) complexes. Several approaches have been employed to study the pharmacodynamics of iron after oral administration. Quantification of iron uptake from radiolabeled preparations by the whole body or the erythrocytes is optimal, but alternatively total iron transfer can be calculated based on known elimination rates and the intrinsic reactivity of individual preparations. Degradation kinetics, and thus the safety, of parenteral iron preparations are directly related to the molecular weight and the stability of the complex. High oral iron doses or rapid release of iron from intravenous iron preparations can saturate the iron transport system, resulting in oxidative stress with adverse clinical and subclinical consequences. Appropriate pharmacokinetics and pharmacodynamics analyses will greatly assist our understanding of the likely contribution of novel preparations to the management of anemia.

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Author and article information

Contributors

Jesse M. G. Hofman:

ORCID: http://orcid.org/0000-0002-1537-5302

j.m.g.hofman@umcg.nl

Michele F. Eisenga: m.f.eisenga@umcg.nl

Adry Diepenbroek: a.diepenbroek@umcg.nl

Ilja M. Nolte: i.m.nolte@umcg.nl

Bastiaan van Dam: b.van.dam@nwz.nl

Ralf Westerhuis: r.westerhuis@dcg.nl

Stephan J. L. Bakker: s.j.l.bakker@umcg.nl

Casper F. M. Franssen: c.f.m.franssen@umcg.nl

Carlo A. J. M. Gaillard: c.a.j.m.gaillard@umcutrecht.nl

Journal

Journal ID (nlm-ta): BMC Nephrol

Journal ID (iso-abbrev): BMC Nephrol

Title: BMC Nephrology

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2369

Publication date (Electronic): 20 September 2018

Publication date PMC-release: 20 September 2018

Publication date Collection: 2018

Volume: 19

Electronic Location Identifier: 242

Affiliations

[1 ]Department of Nephrology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, 9713GZ The Netherlands

[2 ]Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, 9713GZ The Netherlands

[3 ]ISNI 0000 0004 0368 5519, GRID grid.414828.3, Department of Internal Medicine, , Medical Center Alkmaar, ; Wilhelminalaan 12, 1815JD Alkmaar, The Netherlands

[4 ]Dialysis Center Groningen, Hanzeplein 1, Groningen, 9713GZ The Netherlands

[5 ]Department of Internal Medicine and Dermatology, University Medical Center Utrecht, University of Utrecht, Heidelberglaan 100, 3584CX Utrecht, The Netherlands

[6 ]ISNI 0000 0000 9558 4598, GRID grid.4494.d, Department of Internal Medicine, Division of Nephrology, , University Medical Center Groningen, ; Hanzeplein 1, 9713GZ Groningen, The Netherlands

Author information

Jesse M. G. Hofman http://orcid.org/0000-0002-1537-5302

Article

Publisher ID: 1045

DOI: 10.1186/s12882-018-1045-8

PMC ID: 6149056

PubMed ID: 30236065

SO-VID: b04bd918-d362-423e-a6ae-5aab0576d0a2

License:

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 13 November 2017

Date accepted : 12 September 2018

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100006484, Vifor Pharma;

Award ID: Not attributed

Custom metadata

ScienceOpen disciplines: Nephrology

Keywords: ferric carboxymaltose,iron sucrose,hemodialysis,iron status,esa

Data availability:

ScienceOpen disciplines: Nephrology

Keywords: ferric carboxymaltose, iron sucrose, hemodialysis, iron status, esa

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Switching iron sucrose to ferric carboxymaltose associates to better control of iron status in hemodialysis patients

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Abstract

Background

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Electronic supplementary material

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Karger: Nephrology

Most cited references 20

FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease.

FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia

The Pharmacokinetics and Pharmacodynamics of Iron Preparations

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