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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.
Afiliación
  • Bakris GL; Department of Medicine, American Heart Association Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, Illinois, USA.
  • Yang YF; Chief Development Officer, KBP BioSciences USA Inc., Princeton, New Jersey, USA.
  • McCabe JM; Chief Development Officer, KBP BioSciences USA Inc., Princeton, New Jersey, USA.
  • Liu JR; Chief Development Officer, KBP BioSciences USA Inc., Princeton, New Jersey, USA.
  • Tan XJ; Chief Development Officer, KBP BioSciences USA Inc., Princeton, New Jersey, USA.
  • Benn VJ; Chief Development Officer, KBP BioSciences USA Inc., Princeton, New Jersey, USA.
  • Pitt B; Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.
Am J Hypertens ; 36(11): 612-618, 2023 Oct 13.
Article en En | MEDLINE | ID: mdl-37471468
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Am J Hypertens Asunto de la revista: ANGIOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Am J Hypertens Asunto de la revista: ANGIOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos