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A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease
BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) reduce systolic blood pressure (SBP) and increase serum potassium concentration ([K(+)]). This indirect comparison investigated any differences in SBP-lowering and hyperkalemia risk between finerenone, a nonsteroidal MRA, and the steroidal MR...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9972517/ https://www.ncbi.nlm.nih.gov/pubmed/36864892 http://dx.doi.org/10.1093/ckj/sfac234 |
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author | Agarwal, Rajiv Pitt, Bertram Palmer, Biff F Kovesdy, Csaba P Burgess, Ellen Filippatos, Gerasimos Małyszko, Jolanta Ruilope, Luis M Rossignol, Patrick Rossing, Peter Pecoits-Filho, Roberto Anker, Stefan D Joseph, Amer Lawatscheck, Robert Wilson, Daniel Gebel, Martin Bakris, George L |
author_facet | Agarwal, Rajiv Pitt, Bertram Palmer, Biff F Kovesdy, Csaba P Burgess, Ellen Filippatos, Gerasimos Małyszko, Jolanta Ruilope, Luis M Rossignol, Patrick Rossing, Peter Pecoits-Filho, Roberto Anker, Stefan D Joseph, Amer Lawatscheck, Robert Wilson, Daniel Gebel, Martin Bakris, George L |
author_sort | Agarwal, Rajiv |
collection | PubMed |
description | BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) reduce systolic blood pressure (SBP) and increase serum potassium concentration ([K(+)]). This indirect comparison investigated any differences in SBP-lowering and hyperkalemia risk between finerenone, a nonsteroidal MRA, and the steroidal MRA spironolactone ± a potassium binder. METHODS: In FIDELITY (a pooled analysis of FIDELIO-DKD and FIGARO-DKD), a subgroup of patients with treatment-resistant hypertension (TRH) and chronic kidney disease meeting eligibility criteria of the AMBER trial were identified (FIDELITY-TRH). The main outcomes were mean change in SBP, incidence of serum [K(+)] ≥5.5 mmol/L and hyperkalemia-associated treatment discontinuation. Results at ∼17 weeks were compared with 12 weeks from AMBER. RESULTS: In 624 FIDELITY-TRH patients and 295 AMBER patients, the least squares mean change in SBP (mmHg) from baseline was −7.1 for finerenone and −1.3 for placebo {between-group difference −5.74 [95% confidence interval (CI) −7.99 to −3.49], P < .0001} versus −11.7 for spironolactone + patiromer and −10.8 for spironolactone + placebo [between-group difference −1.0 (95% CI −4.4–2.4), P = .58]. The incidence of serum [K(+)] ≥5.5 mmol/L was 12% for finerenone and 3% for placebo versus 35% with spironolactone + patiromer and 64% with spironolactone + placebo. Treatment discontinuation due to hyperkalemia was 0.3% for finerenone and 0% for placebo versus 7% for spironolactone + patiromer and 23% for spironolactone + placebo. CONCLUSIONS: In patients with TRH and chronic kidney disease compared with spironolactone with or without patiromer, finerenone was associated with a lower SBP reduction and lower risk of hyperkalemia and treatment discontinuation. Trial Registration: AMBER (NCT03071263), FIDELIO-DKD (NCT02540993), FIGARO-DKD (NCT02545049) |
format | Online Article Text |
id | pubmed-9972517 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-99725172023-03-01 A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease Agarwal, Rajiv Pitt, Bertram Palmer, Biff F Kovesdy, Csaba P Burgess, Ellen Filippatos, Gerasimos Małyszko, Jolanta Ruilope, Luis M Rossignol, Patrick Rossing, Peter Pecoits-Filho, Roberto Anker, Stefan D Joseph, Amer Lawatscheck, Robert Wilson, Daniel Gebel, Martin Bakris, George L Clin Kidney J Original Article BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) reduce systolic blood pressure (SBP) and increase serum potassium concentration ([K(+)]). This indirect comparison investigated any differences in SBP-lowering and hyperkalemia risk between finerenone, a nonsteroidal MRA, and the steroidal MRA spironolactone ± a potassium binder. METHODS: In FIDELITY (a pooled analysis of FIDELIO-DKD and FIGARO-DKD), a subgroup of patients with treatment-resistant hypertension (TRH) and chronic kidney disease meeting eligibility criteria of the AMBER trial were identified (FIDELITY-TRH). The main outcomes were mean change in SBP, incidence of serum [K(+)] ≥5.5 mmol/L and hyperkalemia-associated treatment discontinuation. Results at ∼17 weeks were compared with 12 weeks from AMBER. RESULTS: In 624 FIDELITY-TRH patients and 295 AMBER patients, the least squares mean change in SBP (mmHg) from baseline was −7.1 for finerenone and −1.3 for placebo {between-group difference −5.74 [95% confidence interval (CI) −7.99 to −3.49], P < .0001} versus −11.7 for spironolactone + patiromer and −10.8 for spironolactone + placebo [between-group difference −1.0 (95% CI −4.4–2.4), P = .58]. The incidence of serum [K(+)] ≥5.5 mmol/L was 12% for finerenone and 3% for placebo versus 35% with spironolactone + patiromer and 64% with spironolactone + placebo. Treatment discontinuation due to hyperkalemia was 0.3% for finerenone and 0% for placebo versus 7% for spironolactone + patiromer and 23% for spironolactone + placebo. CONCLUSIONS: In patients with TRH and chronic kidney disease compared with spironolactone with or without patiromer, finerenone was associated with a lower SBP reduction and lower risk of hyperkalemia and treatment discontinuation. Trial Registration: AMBER (NCT03071263), FIDELIO-DKD (NCT02540993), FIGARO-DKD (NCT02545049) Oxford University Press 2022-10-30 /pmc/articles/PMC9972517/ /pubmed/36864892 http://dx.doi.org/10.1093/ckj/sfac234 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of the ERA. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Original Article Agarwal, Rajiv Pitt, Bertram Palmer, Biff F Kovesdy, Csaba P Burgess, Ellen Filippatos, Gerasimos Małyszko, Jolanta Ruilope, Luis M Rossignol, Patrick Rossing, Peter Pecoits-Filho, Roberto Anker, Stefan D Joseph, Amer Lawatscheck, Robert Wilson, Daniel Gebel, Martin Bakris, George L A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease |
title | A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease |
title_full | A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease |
title_fullStr | A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease |
title_full_unstemmed | A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease |
title_short | A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease |
title_sort | comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9972517/ https://www.ncbi.nlm.nih.gov/pubmed/36864892 http://dx.doi.org/10.1093/ckj/sfac234 |
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