Efficacy and Safety of Low-dose Spironolactone for Chronic Kidney Disease in Type 2 Diabetes.

Autor: Oiwa A; Department of Diabetes, Endocrinology and Metabolism, Division of Internal Medicine, Shinshu University School of Medicine, Matsumoto 390-8621, Japan., Hiwatashi D; Department of Diabetes, Endocrinology and Metabolism, Division of Internal Medicine, Shinshu University School of Medicine, Matsumoto 390-8621, Japan., Takeda T; Takeda Internal Medicine Clinic, Azumino 399-8304, Japan., Miyamoto T; Miyamoto Internal Medicine Clinic, Matsumoto 390-0848, Japan., Kawata I; Department of Diabetes, Endocrinology and Metabolism, Division of Internal Medicine, Shinshu University School of Medicine, Matsumoto 390-8621, Japan., Koinuma M; Center for Clinical Research, Shinshu University Hospital, Matsumoto 390-8621, Japan.; Faculty of Pharmaceutical Sciences, Teikyo Heisei University, Nakano 164-8530, Japan., Yamazaki M; Department of Diabetes, Endocrinology and Metabolism, Division of Internal Medicine, Shinshu University School of Medicine, Matsumoto 390-8621, Japan., Komatsu M; Department of Diabetes, Endocrinology and Metabolism, Division of Internal Medicine, Shinshu University School of Medicine, Matsumoto 390-8621, Japan.
Jazyk: angličtina
Zdroj: The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2023 Aug 18; Vol. 108 (9), pp. 2203-2210.
DOI: 10.1210/clinem/dgad144
Abstrakt: Context: Although adding spironolactone to renin-angiotensin system blockers reduces albuminuria in adults with chronic kidney disease and type 2 diabetes, it increases the risk of hyperkalemia.
Objective: To assess whether a lower dose of spironolactone (12.5 mg/d) reduces the risk of hyperkalemia while maintaining its effect on reducing albuminemia.
Design: Multicenter, open-label, randomized controlled trial.
Setting: This study was conducted from July 2016 to November 2020 in ambulatory care at 3 diabetes medical institutions in Japan.
Patients: We enrolled 130 Japanese adults with type 2 diabetes and albuminuria (≥30 mg/gCre), estimated glomerular filtration rate ≥30 mL/min/1.73 m2, and serum potassium level <5.0 mEq/L.
Interventions: The participants were randomly assigned to the spironolactone-administered and control groups.
Main Outcome Measures: Changes in urine albumin-to-creatinine ratio (UACR) from baseline over the 24-week interventional period.
Results: The spironolactone group showed a significant reduction in UACR from baseline (mean decrease, 103.47 ± 340.80 mg/gCre) compared with the control group, which showed an increased UACR (mean increase, 63.93 ± 310.14 mg/gCre; P = .0007, Wilcoxon rank-sum test and t test). Although the spironolactone group had a statistically significant increase in serum potassium levels, none of the participants had a potassium level ≥5.5 mEq/L at 24 weeks. Further, participants with a higher initial serum potassium level tended to have a smaller increase (estimate, -0.37, analysis of covariance).
Conclusions: Low-dose spironolactone administration reduced albuminuria without causing hyperkalemia. Spironolactone administration, the oldest known and most cost-effective mineralocorticoid receptor antagonist, at lower doses should be reconsidered.
(© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
Databáze: MEDLINE