Servicio de Nefrología, Hospital Universitario Infanta Leonor, Madrid, Spain.
Servicio de Cardiología, Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Universidad de A Coruña (UDC), A Coruña, Spain.
Nefrologia (Engl Ed). 2024 Sep-Oct;44(5):709-720. doi: 10.1016/j.nefroe.2024.10.001. Epub 2024 Oct 28.
Hyperkalemia (HK) is an electrolyte disturbance in the concentration of potassium ions (K), whose risk increases in patients with chronic kidney disease (CKD) or heart failure (HF) and/or in patients being treated with renin-angiotensin-aldosterone system inhibitors (RAASi). The new oral K chelators offer a safe and effective treatment to maintain normokalemia in these patients. The objective of the analysis is to estimate the cost-effectiveness of sodium zirconium cyclosilicate (SZC) for the treatment of chronic HK in patients with CKD or HF versus standard treatment (calcium polystyrene sulfonate and lifestyle modifications) from the perspective of the Spanish National Health System.
Two microsimulation models reflecting the natural history of CKD and HF were used. In both models, K levels were simulated individually. Based on efficacy (reduction of K levels), quality of life of patients (utilities according to health states, and disutilities of events derived from each pathology and adverse events [AEs] of treatment) and costs considered (cost of treatment for HK, of RAASi treatment and its modification, health states, management of events derived from each pathology, HK episodes, and AEs treatment) (, 2022), clinical benefit (quality-adjusted life years [QALYs]) and cost results were obtained. A time horizon of the patient's lifetime was used and a discount rate of 3% was applied for costs and outcomes.
SZC is a more effective option in both pathologies, with a difference in QALYs of 0.476 in CKD and 0.978 in HF compared to standard treatment, and it represents an incremental cost of 3,616 and 14,749, respectively, obtaining an incremental cost-utility ratio of 7,605/QALY in CKD and 15,078/QALY in HF.
SZC is a cost-effective alternative for the treatment of HK in patients with CKD or HF, taking into account the reference efficiency values commonly used in Spain.
高钾血症（hyperkalemia，HK）是指血清钾离子（K）浓度异常，患有慢性肾脏病（chronic kidney disease，CKD）或心力衰竭（heart failure，HF）的患者，以及接受肾素-血管紧张素-醛固酮系统抑制剂（renin-angiotensin-aldosterone system inhibitors，RAASi）治疗的患者发生 HK 的风险更高。新型口服钾结合剂为这些患者维持血钾正常提供了安全有效的治疗方法。本分析旨在从西班牙国家卫生系统的角度，评估相对于标准治疗（聚苯乙烯磺酸钙和生活方式改变），硅酸锆钠（sodium zirconium cyclosilicate，SZC）治疗 CKD 或 HF 合并慢性 HK 患者的成本效果。
使用反映 CKD 和 HF 自然史的两个微观模拟模型。在这两种模型中，均对 K 水平进行了个体模拟。基于疗效（降低 K 水平）、患者的生活质量（根据健康状态的效用和每种疾病及治疗不良反应导致的失能）以及考虑的成本（HK 治疗、RAASi 治疗及其调整、健康状态、每种疾病相关事件管理、HK 发作和治疗不良反应）（2022 年），获得了临床获益（质量调整生命年，QALYs）和成本结果。使用患者终生的时间范围，并对成本和结果应用 3%的贴现率。
在两种疾病中，SZC 都是更有效的选择，与标准治疗相比，CKD 中的 QALYs 差异为 0.476，HF 中为 0.978，增量成本分别为 3616 欧元和 14749 欧元，分别获得 CKD 中 7605 欧元/QALY 和 HF 中 15078 欧元/QALY 的增量成本效用比。
考虑到西班牙常用的参考效率值，SZC 是治疗 CKD 或 HF 合并 HK 患者的一种具有成本效果的选择。
