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Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study

No information is available on the efficacy of ferric carboxymaltose (FCM) in real-world CKD patients outside the hemodialysis setting. We prospectively followed 59 non-hemodialysis CKD patients with iron deficient anemia (IDA: hemoglobin <12.0/<13.5 g/dL in women/men and TSAT < 20% and/or...

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Autores principales: Minutolo, Roberto, Berto, Patrizia, Liberti, Maria Elena, Peruzzu, Nicola, Borrelli, Silvio, Netti, Antonella, Garofalo, Carlo, Conte, Giuseppe, De Nicola, Luca, Del Vecchio, Lucia, Locatelli, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8005153/
https://www.ncbi.nlm.nih.gov/pubmed/33806864
http://dx.doi.org/10.3390/jcm10061322
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author Minutolo, Roberto
Berto, Patrizia
Liberti, Maria Elena
Peruzzu, Nicola
Borrelli, Silvio
Netti, Antonella
Garofalo, Carlo
Conte, Giuseppe
De Nicola, Luca
Del Vecchio, Lucia
Locatelli, Francesco
author_facet Minutolo, Roberto
Berto, Patrizia
Liberti, Maria Elena
Peruzzu, Nicola
Borrelli, Silvio
Netti, Antonella
Garofalo, Carlo
Conte, Giuseppe
De Nicola, Luca
Del Vecchio, Lucia
Locatelli, Francesco
author_sort Minutolo, Roberto
collection PubMed
description No information is available on the efficacy of ferric carboxymaltose (FCM) in real-world CKD patients outside the hemodialysis setting. We prospectively followed 59 non-hemodialysis CKD patients with iron deficient anemia (IDA: hemoglobin <12.0/<13.5 g/dL in women/men and TSAT < 20% and/or ferritin < 100 ng/mL) who were intolerant or non-responders to oral iron. Patients received ferric carboxymaltose (FCM) (single dose of 500 mg) followed by additional doses if iron deficiency persisted. We evaluated efficacy of FCM in terms of increase of hemoglobin, ferritin, and TSAT levels. Direct and indirect costs of FCM were also analyzed in comparison with a hypothetical scenario where same amount of iron as ferric gluconate (FG) was administered intravenously. During the 24 weeks of study, 847 ± 428 mg of FCM per patient were administered. IDA improved after four weeks of FCM and remained stable thereafter. At week-24, mean change (95%CI) from baseline of hemoglobin, ferritin and TSAT were +1.16 g/dL (0.55–1.77), +104 ng/mL (40–168) and +9.5% (5.8–13.2), respectively. These changes were independent from ESA use and clinical setting (non-dialysis CKD, peritoneal dialysis and kidney transplant). Among ESA-treated patients (n = 24), ESA doses significantly decreased by 26% with treatment and stopped either temporarily or persistently in nine patients. FCM, compared to a FG-based scenario, was associated with a cost saving of 288 euros/patient/24 weeks. Saving was the same in ESA users/non-users. Therefore, in non-hemodialysis CKD patients, FCM effectively corrects IDA and allows remarkable cost savings in terms of societal, healthcare and patient perspective.
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spelling pubmed-80051532021-03-29 Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study Minutolo, Roberto Berto, Patrizia Liberti, Maria Elena Peruzzu, Nicola Borrelli, Silvio Netti, Antonella Garofalo, Carlo Conte, Giuseppe De Nicola, Luca Del Vecchio, Lucia Locatelli, Francesco J Clin Med Article No information is available on the efficacy of ferric carboxymaltose (FCM) in real-world CKD patients outside the hemodialysis setting. We prospectively followed 59 non-hemodialysis CKD patients with iron deficient anemia (IDA: hemoglobin <12.0/<13.5 g/dL in women/men and TSAT < 20% and/or ferritin < 100 ng/mL) who were intolerant or non-responders to oral iron. Patients received ferric carboxymaltose (FCM) (single dose of 500 mg) followed by additional doses if iron deficiency persisted. We evaluated efficacy of FCM in terms of increase of hemoglobin, ferritin, and TSAT levels. Direct and indirect costs of FCM were also analyzed in comparison with a hypothetical scenario where same amount of iron as ferric gluconate (FG) was administered intravenously. During the 24 weeks of study, 847 ± 428 mg of FCM per patient were administered. IDA improved after four weeks of FCM and remained stable thereafter. At week-24, mean change (95%CI) from baseline of hemoglobin, ferritin and TSAT were +1.16 g/dL (0.55–1.77), +104 ng/mL (40–168) and +9.5% (5.8–13.2), respectively. These changes were independent from ESA use and clinical setting (non-dialysis CKD, peritoneal dialysis and kidney transplant). Among ESA-treated patients (n = 24), ESA doses significantly decreased by 26% with treatment and stopped either temporarily or persistently in nine patients. FCM, compared to a FG-based scenario, was associated with a cost saving of 288 euros/patient/24 weeks. Saving was the same in ESA users/non-users. Therefore, in non-hemodialysis CKD patients, FCM effectively corrects IDA and allows remarkable cost savings in terms of societal, healthcare and patient perspective. MDPI 2021-03-23 /pmc/articles/PMC8005153/ /pubmed/33806864 http://dx.doi.org/10.3390/jcm10061322 Text en © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Minutolo, Roberto
Berto, Patrizia
Liberti, Maria Elena
Peruzzu, Nicola
Borrelli, Silvio
Netti, Antonella
Garofalo, Carlo
Conte, Giuseppe
De Nicola, Luca
Del Vecchio, Lucia
Locatelli, Francesco
Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study
title Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study
title_full Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study
title_fullStr Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study
title_full_unstemmed Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study
title_short Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study
title_sort ferric carboxymatose in non-hemodialysis ckd patients: a longitudinal cohort study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8005153/
https://www.ncbi.nlm.nih.gov/pubmed/33806864
http://dx.doi.org/10.3390/jcm10061322
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