Effect of KBP-5074 on Blood Pressure in Advanced Chronic Kidney Disease: Results of the BLOCK-CKD Study
| Autor: | Pablo E. Pergola, Nam Vo, Tamar Doliashvili, Belkis Delgado, James McCabe, Y. Fred Yang, Diyan Genov, George L. Bakris, Bertram Pitt, Vincent Benn |
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| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty hypertension Hyperkalemia Urology 030204 cardiovascular system & hematology Kidney Placebo 03 medical and health sciences 0302 clinical medicine Mineralocorticoid receptor Double-Blind Method Piperidines Pharmacokinetics Outcome Assessment Health Care Internal Medicine medicine Humans mineralocorticoid receptor antagonist 030212 general & internal medicine Renal Insufficiency Chronic Aged business.industry Standard treatment blood pressure Original Articles Middle Aged hyperkalemia medicine.disease medicine.anatomical_structure Blood pressure ComputingMethodologies_DOCUMENTANDTEXTPROCESSING Quinolines Pyrazoles Female medicine.symptom business Kidney disease |
| Zdroj: | Hypertension (Dallas, Tex. : 1979) |
| ISSN: | 1524-4563 0194-911X |
| DOI: | 10.1161/hypertensionaha.121.17073 |
| Popis: | Supplemental Digital Content is available in the text. In patients with resistant or poorly controlled hypertension and advanced chronic kidney disease, mineralocorticoid receptor antagonists are recommended; however, hyperkalemia limits their use. BLOCK-CKD was a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that evaluated the safety, efficacy, and pharmacokinetics of KBP-5074, a nonsteroidal mineralocorticoid receptor antagonist, for uncontrolled hypertension in patients with stage 3b/4 chronic kidney disease. The study tested the hypothesis that addition of KBP-5074 to standard treatment lowers blood pressure without increased risk of hyperkalemia. Patients (N=162) were randomly assigned 1:1:1 to once-daily oral treatment with placebo, KBP-5074 0.25 mg, or KBP-5074 0.5 mg. The primary end point was systolic blood pressure change from baseline at day 84. Baseline mean (SD) systolic blood pressure was 155.3 (13.55) mm Hg. After 84 days, the placebo-subtracted treatment mean difference (SE) was −7.0 (3.37) mm Hg with KBP-5074 0.25 mg (P=0.0399) and −10.2 (3.32) mm Hg with KBP-5074 0.5 mg (P=0.0026). Hyperkalemia incidence, ≥5.6 |
| Databáze: | OpenAIRE |
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