保钾利尿剂聚磺苯乙烯钠在高钾血症慢性肾脏病患者中维持肾素-血管紧张素-醛固酮系统抑制剂治疗：真实世界人群倾向性匹配分析与 AMETHYST-DN 研究比较

Maintaining Renin-Angiotensin-Aldosterone System Inhibitor Treatment with Patiromer in Hyperkalaemic Chronic Kidney Disease Patients: Comparison of a Propensity-Matched Real-World Population with AMETHYST-DN.

机构信息

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.

Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

出版信息

Am J Nephrol. 2023;54(9-10):408-415. doi: 10.1159/000533753. Epub 2023 Sep 19.

DOI:10.1159/000533753

PMID:37725919

Abstract

INTRODUCTION

Guideline-directed renin-angiotensin-aldosterone system inhibitor (RAASi) therapy is rarely achieved in clinical settings, often due to hyperkalaemia. We assessed the potassium binder, patiromer, on continuation of RAASi therapy in hyperkalaemic patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM) in the AMETHYST-DN trial, propensity score-matched to a real-world cohort not receiving patiromer (Salford Kidney Study).

METHODS

The phase 2, open-label AMETHYST-DN trial (NCT01371747) randomized 304 adults with CKD on RAASi, T2DM, hyperkalaemia (serum potassium [sK+] >5.0 mEq/L), and hypertension to receive patiromer, 8.4-33.6 g/day for 12 months. Patients underwent propensity score matching for systolic blood pressure (BP), heart failure status, and estimated glomerular filtration rate (eGFR), with 321 patients with CKD, T2DM, hyperkalaemia, and on RAASi from a prospective CKD cohort (Salford Kidney Study). Changes in RAASi utilization, sK+, BP, proteinuria, and eGFR during 12-month follow-up were assessed by Mann-Whitney U or χ2 tests.

RESULTS

Matching produced 135:135 patients with no significant differences in age, sex, systolic BP, sK+, eGFR, or heart failure status, although differences in diastolic BP remained (p < 0.001). After 12 months, 100% of AMETHYST-DN patients receiving patiromer remained on RAASi therapy, whereas 38.5% of the Salford Kidney Cohort discontinued RAASi (p < 0.001); hyperkalaemia contributed in 16% of patients (42% of RAASi discontinuations). Significantly greater reductions in sK+ and BP, but not proteinuria or eGFR, were observed in AMETHYST-DN, compared with Salford Kidney Study patients (p < 0.05).

CONCLUSIONS

These results demonstrate the benefit of patiromer for sK+ management to enable RAASi use while revealing beneficial effects on BP.

摘要

简介

在临床环境中，指南指导的肾素-血管紧张素-醛固酮系统抑制剂（RAASi）治疗很少实现，这通常是由于高钾血症引起的。我们在 AMETHYST-DN 试验中评估了钾结合剂帕替莫尔在慢性肾脏病（CKD）和 2 型糖尿病（T2DM）伴高钾血症的患者中继续 RAASi 治疗的效果，该试验与未接受帕替莫尔治疗的真实世界队列（Salford Kidney Study）进行了倾向评分匹配。

方法

这项 2 期、开放标签的 AMETHYST-DN 试验（NCT01371747）纳入了 304 名正在接受 RAASi 治疗、患有 T2DM、高钾血症（血清钾 [sK+]>5.0 mEq/L）和高血压的 CKD 患者，将其随机分为接受帕替莫尔治疗（8.4-33.6 g/天）12 个月的组。对收缩压（BP）、心力衰竭状态和估算肾小球滤过率（eGFR）进行倾向评分匹配，从前瞻性 CKD 队列（Salford Kidney Study）中选择了 321 名 CKD、T2DM、高钾血症和正在接受 RAASi 治疗的患者。在 12 个月的随访期间，通过 Mann-Whitney U 或 χ2 检验评估 RAASi 使用率、sK+、BP、蛋白尿和 eGFR 的变化。

结果

匹配产生了 135:135 名患者，他们的年龄、性别、收缩压、sK+、eGFR 或心力衰竭状态无显著差异，但舒张压仍存在差异（p < 0.001）。12 个月后，100%的 AMETHYST-DN 患者继续接受 RAASi 治疗，而 Salford Kidney Cohort 中 38.5%的患者停止了 RAASi 治疗（p < 0.001）；高钾血症导致 16%的患者（RAASi 停药患者的 42%）停药。与 Salford Kidney Study 患者相比，AMETHYST-DN 患者的 sK+和 BP 显著降低（p < 0.05），但蛋白尿或 eGFR 没有降低。