Renin-Angiotensin-Aldosterone System Inhibitor Dosing After Initiation of Outpatient Sodium Zirconium Cyclosilicate Therapy: The GALVANIZE RAASi Real-World Evidence Study.

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-06-18 DOI:10.1007/s12325-025-03254-z

Abiy Agiro, Ali Greatsinger, Fan Mu, Erin E Cook, Jingyi Chen, Manasvi Sundar, Angela Zhao, Ellen Colman, Arun Malhotra

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引用次数: 0

Abstract

Introduction: The use of renin-angiotensin-aldosterone system inhibitors (RAASi), including mineralocorticoid receptor antagonists (MRAs), can cause or exacerbate hyperkalemia, especially in patients with chronic kidney disease (CKD) and heart failure (HF). Prior research has demonstrated that sodium zirconium cyclosilicate (SZC) can enable continued RAASi use in patients with hyperkalemia. This study, GALVANIZE RAASi, sought to describe the proportion of patients with hyperkalemia who had an optimized or maximized RAASi dose after the initiation of outpatient SZC therapy.

Methods: Using data from a large US insurance claims database from July 2018-December 2022, adults initiating SZC in the outpatient setting (index) while using a RAASi (≥ 7 day overlap with index and ≥ 1 RAASi fill in the 6-month follow-up period) were selected. Sub-studies included patients with baseline diagnosis codes for CKD or HF and patients with ≥ 1 MRA prescription during follow-up. The proportion of patients with an optimized (≥ 50% of target dose) or maximized (≥ 100% of target dose) RAASi dose during follow-up was described.

Results: Of the 2973 patients meeting study inclusion criteria who were included in the overall sample, 2549 were included in the CKD sub-study, 879 in the HF sub-study and 395 in the MRA sub-study. In the overall sample, 63.7% of patients had an optimized RAASi dose and 27.2% of patients had a maximized RAASi dose during follow-up, and the results were similar across sub-studies (optimized RAASi dose: 62.9-72.6%; maximized RAASi dose: 26.9-36.1%).

Conclusion: In this real-world study of patients with RAASi use after SZC initiation, about two-thirds of patients had an optimized RAASi dose and more than a quarter of patients had a maximized RAASi dose within 6 months of starting SZC. Findings were consistent across sub-studies of patients with CKD, HF and treatment with MRA. SZC may support the maintenance of optimal RAASi therapy; however, further comparative analyses are warranted. Graphical abstract available for this article.

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门诊开始环硅酸锆钠治疗后肾素-血管紧张素-醛固酮系统抑制剂的剂量：GALVANIZE RAASi真实世界证据研究。

使用肾素-血管紧张素-醛固酮系统抑制剂（RAASi），包括矿皮质激素受体拮抗剂（MRAs），可引起或加重高钾血症，特别是在慢性肾病（CKD）和心力衰竭（HF）患者中。先前的研究表明，环硅酸锆钠（SZC）可以使高钾血症患者继续使用RAASi。这项研究，GALVANIZE RAASi，试图描述在门诊SZC治疗开始后，高钾血症患者的RAASi剂量优化或最大化的比例。方法：使用2018年7月至2022年12月美国大型保险索赔数据库的数据，选择在门诊开始SZC的成年人（指数），同时使用RAASi（与指数重叠≥7天，在6个月的随访期间填写≥1个RAASi）。亚研究包括基线诊断代码为CKD或HF的患者和随访期间MRA处方≥1的患者。描述随访期间RAASi剂量达到最佳（≥目标剂量的50%）或最大（≥目标剂量的100%）的患者比例。结果：在符合研究纳入标准的2973例患者中，2549例被纳入CKD亚研究，879例被纳入HF亚研究，395例被纳入MRA亚研究。在整个样本中，63.7%的患者在随访期间获得了最佳RAASi剂量，27.2%的患者获得了最大RAASi剂量，并且在各个子研究中结果相似(优化RAASi剂量：62.9-72.6%；RAASi最大剂量：26.9-36.1%)。结论：在这项对SZC开始后使用RAASi的患者的现实研究中，约三分之二的患者在SZC开始后6个月内获得了最佳RAASi剂量，超过四分之一的患者在SZC开始后6个月内获得了最大RAASi剂量。在CKD、HF患者和MRA治疗的亚研究中，结果是一致的。SZC可能支持维持最佳RAASi治疗；然而，进一步的比较分析是必要的。本文提供图形摘要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.