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Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE

BACKGROUND: Sodium zirconium cyclosilicate (SZC) is an effective and well-tolerated treatment for hyperkalemia in maintenance hemodialysis patients. In post-hoc analyses of the phase 3b DIALIZE study, we examined the spectrum of potassium responses to SZC. METHODS: Post-hoc analyses with SZC and pla...

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Autores principales: Fishbane, Steven, Ford, Martin, Fukagawa, Masafumi, McCafferty, Kieran, Rastogi, Anjay, Spinowitz, Bruce, Staroselskiy, Konstantin, Vishnevskiy, Konstantin, Lisovskaja, Vera, Al-Shurbaji, Ayman, Guzman, Nicolas, Bhandari, Sunil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8826669/
https://www.ncbi.nlm.nih.gov/pubmed/35135481
http://dx.doi.org/10.1186/s12882-021-02569-7
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author Fishbane, Steven
Ford, Martin
Fukagawa, Masafumi
McCafferty, Kieran
Rastogi, Anjay
Spinowitz, Bruce
Staroselskiy, Konstantin
Vishnevskiy, Konstantin
Lisovskaja, Vera
Al-Shurbaji, Ayman
Guzman, Nicolas
Bhandari, Sunil
author_facet Fishbane, Steven
Ford, Martin
Fukagawa, Masafumi
McCafferty, Kieran
Rastogi, Anjay
Spinowitz, Bruce
Staroselskiy, Konstantin
Vishnevskiy, Konstantin
Lisovskaja, Vera
Al-Shurbaji, Ayman
Guzman, Nicolas
Bhandari, Sunil
author_sort Fishbane, Steven
collection PubMed
description BACKGROUND: Sodium zirconium cyclosilicate (SZC) is an effective and well-tolerated treatment for hyperkalemia in maintenance hemodialysis patients. In post-hoc analyses of the phase 3b DIALIZE study, we examined the spectrum of potassium responses to SZC. METHODS: Post-hoc analyses with SZC and placebo included: the number of long interdialytic interval (LIDI) visits during the 4-week evaluation period where patients attained pre-dialysis serum potassium (sK(+)) concentrations of 4.0–5.0 and 4.0–5.5 mmol/L; potassium gradient (the difference between pre-dialysis sK(+) and dialysate potassium) at days 36, 43, 50, and 57, and change from baseline to the end of treatment (EOT) using categories of potassium gradient (1 to < 2, 2 to < 3, 3 to < 4, and ≥ 4 mmol/L). RESULTS: A greater proportion of patients achieved the ranges of pre-dialysis sK(+) concentration with SZC versus placebo for ≥1, ≥ 2, ≥ 3, and 4 LIDI visits over 4 weeks; 23.7 and 48.5% of patients in the SZC group achieved pre-dialysis sK(+) concentrations of 4.0–5.0 and 4.0–5.5 mmol/L, respectively, at all 4 LIDI visits. Baseline mean potassium gradient was similar with SZC and placebo. At day 57, mean (standard deviation) potassium gradient was 2.78 (0.08) mmol/L with SZC and 3.52 (0.08) mmol/L with placebo; mean difference (95% confidence interval) was − 0.74 mmol/L (− 0.97 to − 0.52). A greater reduction in potassium gradient category from baseline towards lower-risk categories at EOT was observed with SZC versus placebo. CONCLUSIONS: These analyses expand our knowledge of the spectrum of potassium responses with SZC in hyperkalemic hemodialysis patients. TRIAL REGISTRATION: NCT03303521.
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spelling pubmed-88266692022-02-10 Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE Fishbane, Steven Ford, Martin Fukagawa, Masafumi McCafferty, Kieran Rastogi, Anjay Spinowitz, Bruce Staroselskiy, Konstantin Vishnevskiy, Konstantin Lisovskaja, Vera Al-Shurbaji, Ayman Guzman, Nicolas Bhandari, Sunil BMC Nephrol Research BACKGROUND: Sodium zirconium cyclosilicate (SZC) is an effective and well-tolerated treatment for hyperkalemia in maintenance hemodialysis patients. In post-hoc analyses of the phase 3b DIALIZE study, we examined the spectrum of potassium responses to SZC. METHODS: Post-hoc analyses with SZC and placebo included: the number of long interdialytic interval (LIDI) visits during the 4-week evaluation period where patients attained pre-dialysis serum potassium (sK(+)) concentrations of 4.0–5.0 and 4.0–5.5 mmol/L; potassium gradient (the difference between pre-dialysis sK(+) and dialysate potassium) at days 36, 43, 50, and 57, and change from baseline to the end of treatment (EOT) using categories of potassium gradient (1 to < 2, 2 to < 3, 3 to < 4, and ≥ 4 mmol/L). RESULTS: A greater proportion of patients achieved the ranges of pre-dialysis sK(+) concentration with SZC versus placebo for ≥1, ≥ 2, ≥ 3, and 4 LIDI visits over 4 weeks; 23.7 and 48.5% of patients in the SZC group achieved pre-dialysis sK(+) concentrations of 4.0–5.0 and 4.0–5.5 mmol/L, respectively, at all 4 LIDI visits. Baseline mean potassium gradient was similar with SZC and placebo. At day 57, mean (standard deviation) potassium gradient was 2.78 (0.08) mmol/L with SZC and 3.52 (0.08) mmol/L with placebo; mean difference (95% confidence interval) was − 0.74 mmol/L (− 0.97 to − 0.52). A greater reduction in potassium gradient category from baseline towards lower-risk categories at EOT was observed with SZC versus placebo. CONCLUSIONS: These analyses expand our knowledge of the spectrum of potassium responses with SZC in hyperkalemic hemodialysis patients. TRIAL REGISTRATION: NCT03303521. BioMed Central 2022-02-08 /pmc/articles/PMC8826669/ /pubmed/35135481 http://dx.doi.org/10.1186/s12882-021-02569-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Fishbane, Steven
Ford, Martin
Fukagawa, Masafumi
McCafferty, Kieran
Rastogi, Anjay
Spinowitz, Bruce
Staroselskiy, Konstantin
Vishnevskiy, Konstantin
Lisovskaja, Vera
Al-Shurbaji, Ayman
Guzman, Nicolas
Bhandari, Sunil
Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE
title Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE
title_full Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE
title_fullStr Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE
title_full_unstemmed Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE
title_short Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE
title_sort potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of dialize
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8826669/
https://www.ncbi.nlm.nih.gov/pubmed/35135481
http://dx.doi.org/10.1186/s12882-021-02569-7
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