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Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study
BACKGROUND: Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney disease (CKD) with uncontrolled or resistant hypertension (BLOCK-CKD study). However, the efficacy and safety of Ocedurenone in s...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10570658/ https://www.ncbi.nlm.nih.gov/pubmed/37471468 http://dx.doi.org/10.1093/ajh/hpad066 |
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author | Bakris, George L Yang, Y Fred McCabe, James M Liu, Jin Rong Tan, Xiaojuan J Benn, Vincent J Pitt, Bertram |
author_facet | Bakris, George L Yang, Y Fred McCabe, James M Liu, Jin Rong Tan, Xiaojuan J Benn, Vincent J Pitt, Bertram |
author_sort | Bakris, George L |
collection | PubMed |
description | BACKGROUND: Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney disease (CKD) with uncontrolled or resistant hypertension (BLOCK-CKD study). However, the efficacy and safety of Ocedurenone in subgroups such as Hispanic patients or those with stage 4 CKD, diabetes, or very high albuminuria have not been reported. METHODS: A total of 162 patients were enrolled in the BLOCK-CKD study. The primary endpoint of these analyses was change in systolic blood pressure (SBP) from baseline to day 84. Prespecified subgroup analysis of SBP focused on demographic (e.g., ethnicity, age) and medical (e.g., CKD stage, diabetes, albuminuria, baseline estimated glomerular filtration rate [eGFR]). The safety analysis focused on changes in serum potassium levels from baseline. RESULTS: SBP reductions were consistent across subgroups compared with the overall study cohort. Placebo-adjusted SBP reductions were observed in Hispanic patients (−8.1 and −9.9 mm Hg for 0.25 and 0.5 mg, respectively, total n = 35) and patients with CKD stage 4 (−9.3 and −10.4 mm Hg for 0.25 and 0.5 mg, respectively, total n = 64), diabetes (−6.9 and −11.6 mm Hg for 0.25 and 0.5 mg, respectively, total n = 51), and very high albuminuria (−13.1 and −12.3 mm Hg for 0.25 and 0.5 mg, respectively, total n = 85). Changes in serum potassium were similar across all patient subgroups regardless of baseline eGFR, diabetes status, or degree of proteinuria. No cases of hyperkalemia required intervention or resulted in study discontinuation. CONCLUSIONS: Ocedurenone consistently reduced in SBP in all patient subgroups. Moreover, while small elevations in serum potassium occurred, they were not associated with Ocedurenone or study discontinuation. |
format | Online Article Text |
id | pubmed-10570658 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-105706582023-10-14 Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study Bakris, George L Yang, Y Fred McCabe, James M Liu, Jin Rong Tan, Xiaojuan J Benn, Vincent J Pitt, Bertram Am J Hypertens Original Contributions BACKGROUND: Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney disease (CKD) with uncontrolled or resistant hypertension (BLOCK-CKD study). However, the efficacy and safety of Ocedurenone in subgroups such as Hispanic patients or those with stage 4 CKD, diabetes, or very high albuminuria have not been reported. METHODS: A total of 162 patients were enrolled in the BLOCK-CKD study. The primary endpoint of these analyses was change in systolic blood pressure (SBP) from baseline to day 84. Prespecified subgroup analysis of SBP focused on demographic (e.g., ethnicity, age) and medical (e.g., CKD stage, diabetes, albuminuria, baseline estimated glomerular filtration rate [eGFR]). The safety analysis focused on changes in serum potassium levels from baseline. RESULTS: SBP reductions were consistent across subgroups compared with the overall study cohort. Placebo-adjusted SBP reductions were observed in Hispanic patients (−8.1 and −9.9 mm Hg for 0.25 and 0.5 mg, respectively, total n = 35) and patients with CKD stage 4 (−9.3 and −10.4 mm Hg for 0.25 and 0.5 mg, respectively, total n = 64), diabetes (−6.9 and −11.6 mm Hg for 0.25 and 0.5 mg, respectively, total n = 51), and very high albuminuria (−13.1 and −12.3 mm Hg for 0.25 and 0.5 mg, respectively, total n = 85). Changes in serum potassium were similar across all patient subgroups regardless of baseline eGFR, diabetes status, or degree of proteinuria. No cases of hyperkalemia required intervention or resulted in study discontinuation. CONCLUSIONS: Ocedurenone consistently reduced in SBP in all patient subgroups. Moreover, while small elevations in serum potassium occurred, they were not associated with Ocedurenone or study discontinuation. Oxford University Press 2023-07-20 /pmc/articles/PMC10570658/ /pubmed/37471468 http://dx.doi.org/10.1093/ajh/hpad066 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of American Journal of Hypertension, Ltd. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Contributions Bakris, George L Yang, Y Fred McCabe, James M Liu, Jin Rong Tan, Xiaojuan J Benn, Vincent J Pitt, Bertram Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study |
title | Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study |
title_full | Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study |
title_fullStr | Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study |
title_full_unstemmed | Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study |
title_short | Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study |
title_sort | efficacy and safety of ocedurenone: subgroup analysis of the block-ckd study |
topic | Original Contributions |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10570658/ https://www.ncbi.nlm.nih.gov/pubmed/37471468 http://dx.doi.org/10.1093/ajh/hpad066 |
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