Effect of spironolactone wash-out on albuminuria after long-term treatment in individuals with type 2 diabetes and high risk of kidney disease-An observational follow-up of the PRIORITY study.

IF 5.4 2区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes, Obesity & Metabolism Pub Date : 2024-10-28 DOI:10.1111/dom.16037

Victor Wasehuus, Viktor Rotbain Curovic, Nete Tofte, Morten Lindhardt, Gemma Currie, Christian Delles, Marie Frimodt-Møller, Harald Mischak, Heiko von der Leyen, Tine Willum Hansen, Thomas Kümler, Frederik Persson, Peter Rossing

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Abstract

Aims: This study aimed to explore the effect of discontinuation of long-term spironolactone treatment on markers of kidney function in individuals with type 2 diabetes (T2D) at high risk of kidney disease enrolled in the Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria (PRIORITY) study.

Materials and methods: An observational study following the nested randomised part of the PRIORITY study was conducted. A total of 115 individuals with T2D and normoalbuminuria but high risk for progression based on urinary proteomics, randomised to daily spironolactone (n = 50) or placebo (n = 65) for a median of 2.5 years, were re-examined approximately 6 weeks after the final visit in the PRIORITY study. Primary endpoint was relative change in geometric mean of urinary albumin-creatinine ratio (UACR) between the final visit in PRIORITY (baseline) and follow-up. Secondary endpoints were change in estimated glomerular filtration rate (eGFR), systolic blood pressure (SBP) and serum potassium.

Results: No change in UACR was observed in neither the spironolactone (geometric mean change: 17%; 95% CI -12, 55; p = 0.28) nor the placebo (5%; 95% CI -13, 26; p = 0.63) group at follow-up. No difference in UACR between the groups was observed at follow-up (relative difference in geometric mean: 11%, 95% CI -26, 67; p = 0.60). For eGFR and SBP, an increase after discontinuation of spironolactone was observed, as well as for SBP after placebo discontinuation. Potassium levels were lower after discontinuation of spironolactone, but higher after placebo discontinuation (all p < 0.05).

Conclusions: UACR did not change after discontinuation of long-term treatment with spironolactone. However, an increase in eGFR was observed supporting a haemodynamic effect of spironolactone in the kidneys.

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螺内酯停用对 2 型糖尿病和肾病高风险患者长期治疗后白蛋白尿的影响--PRIORITY 研究的观察性随访。

目的：本研究旨在探讨在蛋白质组预测和肾素血管紧张素醛固酮系统抑制预防正常白蛋白尿的 2 型糖尿病患者早期糖尿病肾病（PRIORITY）研究中，停止长期螺内酯治疗对 2 型糖尿病肾病高危人群肾功能指标的影响：根据 PRIORITY 研究的嵌套随机部分进行了一项观察性研究。共有 115 名患有 T2D 和正常白蛋白尿，但根据尿液蛋白质组学检查发现病情恶化风险较高的患者被随机分配到每日服用螺内酯（50 人）或安慰剂（65 人），中位时间为 2.5 年，他们在 PRIORITY 研究最后一次就诊约 6 周后接受了复查。主要终点是 PRIORITY 最后一次检查（基线）和随访之间尿白蛋白-肌酐比值几何平均（UACR）的相对变化。次要终点是估计肾小球滤过率（eGFR）、收缩压（SBP）和血清钾的变化：随访期间，螺内酯组（几何平均变化率：17%；95% CI -12，55；P = 0.28）和安慰剂组（5%；95% CI -13，26；P = 0.63）的 UACR 均无变化。随访时未观察到组间 UACR 的差异（几何平均相对差异：11%，95% CI -26，67；P = 0.60）。就 eGFR 和 SBP 而言，观察到停用螺内酯后 eGFR 和 SBP 有所上升，停用安慰剂后 SBP 也有所上升。停用螺内酯后血钾水平降低，但停用安慰剂后血钾水平升高（均为 p 结论）：停止使用螺内酯的长期治疗后，尿酸排泄率没有变化。然而，观察到 eGFR 有所增加，这支持了螺内酯对肾脏血液动力学的影响。

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来源期刊

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.