The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis

Abstract Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), demonstrated its effectiveness for lowering serum phosphate levels, with low daily pill burden, in clinical trials of dialysis patients with hyperphosphatemia. This retrospective database analysis evaluated th...

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Main Authors: Rosa Ramos, Charles Chazot, Anibal Ferreira, Attilio Di Benedetto, Konstantin Gurevich, Astrid Feuersenger, Melanie Wolf, Hans-Jürgen Arens, Sebastian Walpen, Stefano Stuard
Format: Article
Language:English
Published: BMC 2020-12-01
Series:BMC Nephrology
Subjects:
Online Access:https://doi.org/10.1186/s12882-020-02188-8
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author Rosa Ramos
Charles Chazot
Anibal Ferreira
Attilio Di Benedetto
Konstantin Gurevich
Astrid Feuersenger
Melanie Wolf
Hans-Jürgen Arens
Sebastian Walpen
Stefano Stuard
author_facet Rosa Ramos
Charles Chazot
Anibal Ferreira
Attilio Di Benedetto
Konstantin Gurevich
Astrid Feuersenger
Melanie Wolf
Hans-Jürgen Arens
Sebastian Walpen
Stefano Stuard
author_sort Rosa Ramos
collection DOAJ
description Abstract Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), demonstrated its effectiveness for lowering serum phosphate levels, with low daily pill burden, in clinical trials of dialysis patients with hyperphosphatemia. This retrospective database analysis evaluated the real-world effectiveness of SFOH for controlling serum phosphate in European hemodialysis patients. Methods De-identified patient data were extracted from a clinical database (EuCliD®) for adult hemodialysis patients from France, Italy, Portugal, Russia and Spain who were newly prescribed SFOH for up to 1 year as part of routine clinical care. Serum phosphate and pill burden were compared between baseline (3-month period before starting SFOH) and four consecutive quarterly periods of SFOH therapy (Q1−Q4; 12 months) in the overall cohort and three subgroups: PB-naïve patients treated with SFOH monotherapy (mSFOH), and PB-pretreated patients who were either switched to SFOH monotherapy (PB → mSFOH), or received SFOH in addition to another PB (PB + SFOH). Results 1096 hemodialysis patients (mean age: 60.6 years; 65.8% male) were analyzed, including 796, 188 and 53 patients in, respectively, the PB + SFOH, mSFOH, and PB → mSFOH groups. In the overall cohort, serum phosphate decreased significantly from 1.88 mmol/L at baseline to 1.77–1.69 mmol/L during Q1–Q4, and the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased from 41.3% at baseline to 56.2–62.7% during SFOH treatment. Mean PB pill burden decreased from 6.3 pills/day at baseline to 5.0–5.3 pills/day during Q1–Q4. The subgroup analysis found the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased significantly from baseline during SFOH treatment in the PB + SFOH group (from 38.1% up to 60.9% [Q2]) and the mSFOH group (from 49.5% up to 75.2% [Q2]), but there were no significant changes in the PB → mSFOH group. For the PB + SFOH group, serum phosphate reductions were achieved with a similar number of PB pills prescribed at baseline prior to SFOH treatment (6.5 vs 6.2 pills/day at Q4). SFOH daily pill burden was low across all 3 subgroups (2.1–2.8 pills/day). Conclusion In this real-world study of European hemodialysis patients, prescription of SFOH as monotherapy to PB-naïve patients, or in addition to existing PB therapy, was associated with significant improvements in serum phosphate control and a low daily pill burden.
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spelling doaj.art-1ad472bf98674f95a0199c5a754f5eeb2022-12-21T22:22:17ZengBMCBMC Nephrology1471-23692020-12-0121111210.1186/s12882-020-02188-8The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysisRosa Ramos0Charles Chazot1Anibal Ferreira2Attilio Di Benedetto3Konstantin Gurevich4Astrid Feuersenger5Melanie Wolf6Hans-Jürgen Arens7Sebastian Walpen8Stefano Stuard9NephroCare Spain, NephrologyNephroCare FranceNephroCare Vila Franca de Xira, NephrologyNephroCare Italy, Medical DirectionFresenius Medical Care RussiaFresenius Medical Care Deutschland GmbHFresenius Medical Care Deutschland GmbHFresenius Medical Care Deutschland GmbHVifor Fresenius Medical Care Renal Pharma, NephrologyFresenius Medical Care, Clinical & Therapeutical GovernanceAbstract Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), demonstrated its effectiveness for lowering serum phosphate levels, with low daily pill burden, in clinical trials of dialysis patients with hyperphosphatemia. This retrospective database analysis evaluated the real-world effectiveness of SFOH for controlling serum phosphate in European hemodialysis patients. Methods De-identified patient data were extracted from a clinical database (EuCliD®) for adult hemodialysis patients from France, Italy, Portugal, Russia and Spain who were newly prescribed SFOH for up to 1 year as part of routine clinical care. Serum phosphate and pill burden were compared between baseline (3-month period before starting SFOH) and four consecutive quarterly periods of SFOH therapy (Q1−Q4; 12 months) in the overall cohort and three subgroups: PB-naïve patients treated with SFOH monotherapy (mSFOH), and PB-pretreated patients who were either switched to SFOH monotherapy (PB → mSFOH), or received SFOH in addition to another PB (PB + SFOH). Results 1096 hemodialysis patients (mean age: 60.6 years; 65.8% male) were analyzed, including 796, 188 and 53 patients in, respectively, the PB + SFOH, mSFOH, and PB → mSFOH groups. In the overall cohort, serum phosphate decreased significantly from 1.88 mmol/L at baseline to 1.77–1.69 mmol/L during Q1–Q4, and the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased from 41.3% at baseline to 56.2–62.7% during SFOH treatment. Mean PB pill burden decreased from 6.3 pills/day at baseline to 5.0–5.3 pills/day during Q1–Q4. The subgroup analysis found the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased significantly from baseline during SFOH treatment in the PB + SFOH group (from 38.1% up to 60.9% [Q2]) and the mSFOH group (from 49.5% up to 75.2% [Q2]), but there were no significant changes in the PB → mSFOH group. For the PB + SFOH group, serum phosphate reductions were achieved with a similar number of PB pills prescribed at baseline prior to SFOH treatment (6.5 vs 6.2 pills/day at Q4). SFOH daily pill burden was low across all 3 subgroups (2.1–2.8 pills/day). Conclusion In this real-world study of European hemodialysis patients, prescription of SFOH as monotherapy to PB-naïve patients, or in addition to existing PB therapy, was associated with significant improvements in serum phosphate control and a low daily pill burden.https://doi.org/10.1186/s12882-020-02188-8Chronic kidney diseaseEnd-stage renal diseaseHemodialysisHyperphosphatemiaPhosphate binderSucroferric oxyhydroxide
spellingShingle Rosa Ramos
Charles Chazot
Anibal Ferreira
Attilio Di Benedetto
Konstantin Gurevich
Astrid Feuersenger
Melanie Wolf
Hans-Jürgen Arens
Sebastian Walpen
Stefano Stuard
The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis
BMC Nephrology
Chronic kidney disease
End-stage renal disease
Hemodialysis
Hyperphosphatemia
Phosphate binder
Sucroferric oxyhydroxide
title The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis
title_full The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis
title_fullStr The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis
title_full_unstemmed The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis
title_short The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis
title_sort real world effectiveness of sucroferric oxyhydroxide in european hemodialysis patients a 1 year retrospective database analysis
topic Chronic kidney disease
End-stage renal disease
Hemodialysis
Hyperphosphatemia
Phosphate binder
Sucroferric oxyhydroxide
url https://doi.org/10.1186/s12882-020-02188-8
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