Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study
Patients undergoing hemodialysis with iron deficiency anemia (IDA) receiving treatment with erythropoiesis-stimulating agents (ESAs) who were intolerant or non-responsive to intravenous (i.v.) ferric gluconate (FG) (hemoglobin; Hb values < 10.5 g/dL or increase in <1 g/dL) or % transferrin sat...
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MDPI AG
2022-09-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/11/18/5284 |
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| author | Alberto Rosati Paolo Conti Patrizia Berto Sabrina Molinaro Federica Baldini Colin Gerard Egan Vincenzo Panichi |
| author_facet | Alberto Rosati Paolo Conti Patrizia Berto Sabrina Molinaro Federica Baldini Colin Gerard Egan Vincenzo Panichi |
| author_sort | Alberto Rosati |
| collection | DOAJ |
| description | Patients undergoing hemodialysis with iron deficiency anemia (IDA) receiving treatment with erythropoiesis-stimulating agents (ESAs) who were intolerant or non-responsive to intravenous (i.v.) ferric gluconate (FG) (hemoglobin; Hb values < 10.5 g/dL or increase in <1 g/dL) or % transferrin saturation; TSAT of <20%) in the previous 6 months were switched to i.v. ferric carboxymaltose (FCM). Changes in iron status parameters, economic and safety measures were also assessed. Seventy-seven hemodialysis patients aged 68 ± 15 years were included. Erythropoietin resistance index decreased from 24.2 ± 14.6 at pre-switch to 20.4 ± 14.6 after 6 months of FCM treatment and Hb levels ≥10.5 g/dL improved from 61% to 75.3% patients (<i>p</i> = 0.042). A 1 g/dL increase in Hb levels was also seen in 26% of patients as well as a 37.7% increase in patients achieving >20% increase in TSAT after FCM. Levels of Hb, TSAT and ferritin parameters increased during FCM treatment with a concomitant decrease in ESA. A mixed-model analysis, which also considered gender, confirmed these trends. Safety variables remained stable, no hypersensitivity reaction was recorded and only one patient reported an adverse event after FCM. FCM treatment was associated with a cost saving of 11.11 EUR/patient/month. These results confirm the efficacy, safety and cost-effectiveness of FCM in correcting IDA in hemodialysis patients. |
| first_indexed | 2024-03-09T23:36:45Z |
| format | Article |
| id | doaj.art-1d3411b4c1554255857655fb61a3fc71 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-09T23:36:45Z |
| publishDate | 2022-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-1d3411b4c1554255857655fb61a3fc712023-11-23T16:58:03ZengMDPI AGJournal of Clinical Medicine2077-03832022-09-011118528410.3390/jcm11185284Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective StudyAlberto Rosati0Paolo Conti1Patrizia Berto2Sabrina Molinaro3Federica Baldini4Colin Gerard Egan5Vincenzo Panichi6SOC Nefrologia e Dialisi, Ospedale San Giovanni di Dio, 50143 Firenze, ItalyNephrology and Dialysis Unit, Nephrology Department, Arezzo Hospital, 52100 Arezzo, ItalyRegulatory Pharma Net S.r.L., 56125 Pisa, ItalyNational Research Council, Institute of Clinical Physiology (CNR-IFC), 56124 Pisa, ItalyNational Research Council, Institute of Clinical Physiology (CNR-IFC), 56124 Pisa, ItalyCE Medical Writing S.r.L.S., 56021 Pisa, ItalyNephrology and Dialysis Unit, Versilia Hospital, 55049 Lido Di Camaiore, ItalyPatients undergoing hemodialysis with iron deficiency anemia (IDA) receiving treatment with erythropoiesis-stimulating agents (ESAs) who were intolerant or non-responsive to intravenous (i.v.) ferric gluconate (FG) (hemoglobin; Hb values < 10.5 g/dL or increase in <1 g/dL) or % transferrin saturation; TSAT of <20%) in the previous 6 months were switched to i.v. ferric carboxymaltose (FCM). Changes in iron status parameters, economic and safety measures were also assessed. Seventy-seven hemodialysis patients aged 68 ± 15 years were included. Erythropoietin resistance index decreased from 24.2 ± 14.6 at pre-switch to 20.4 ± 14.6 after 6 months of FCM treatment and Hb levels ≥10.5 g/dL improved from 61% to 75.3% patients (<i>p</i> = 0.042). A 1 g/dL increase in Hb levels was also seen in 26% of patients as well as a 37.7% increase in patients achieving >20% increase in TSAT after FCM. Levels of Hb, TSAT and ferritin parameters increased during FCM treatment with a concomitant decrease in ESA. A mixed-model analysis, which also considered gender, confirmed these trends. Safety variables remained stable, no hypersensitivity reaction was recorded and only one patient reported an adverse event after FCM. FCM treatment was associated with a cost saving of 11.11 EUR/patient/month. These results confirm the efficacy, safety and cost-effectiveness of FCM in correcting IDA in hemodialysis patients.https://www.mdpi.com/2077-0383/11/18/5284ferric carboxymaltoseintravenous iron supplementationiron deficiency anemiachronic kidney diseasehemodialysishemoglobin |
| spellingShingle | Alberto Rosati Paolo Conti Patrizia Berto Sabrina Molinaro Federica Baldini Colin Gerard Egan Vincenzo Panichi Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study Journal of Clinical Medicine ferric carboxymaltose intravenous iron supplementation iron deficiency anemia chronic kidney disease hemodialysis hemoglobin |
| title | Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study |
| title_full | Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study |
| title_fullStr | Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study |
| title_full_unstemmed | Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study |
| title_short | Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study |
| title_sort | efficacy safety and pharmacoeconomic analysis of intravenous ferric carboxymaltose in anemic hemodialysis patients unresponsive to ferric gluconate treatment a multicenter retrospective study |
| topic | ferric carboxymaltose intravenous iron supplementation iron deficiency anemia chronic kidney disease hemodialysis hemoglobin |
| url | https://www.mdpi.com/2077-0383/11/18/5284 |
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