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开始使用环硅酸锆钠或帕替罗姆的患者中心力衰竭与水肿事件的关联

The Association of Heart Failure and Edema Events between Patients Initiating Sodium Zirconium Cyclosilicate or Patiromer.

作者信息

Desai Nihar R, Kammerer Jennifer, Budden Jeffrey, Olopoenia Abisola, Tysseling Asa, Gordon Alexandra

机构信息

Section of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut.

CSL Vifor, Redwood City, California.

出版信息

Kidney360. 2024 Dec 1;5(12):1835-1843. doi: 10.34067/KID.0000000586. Epub 2024 Sep 20.

Abstract

KEY POINTS

One previous study using claims data reported signals for higher hospitalizations for heart failures and severe edema in patients prescribed a potassium binder using sodium exchange. In this study, sodium zirconium cyclosilicate use was associated with increased risk of prespecified encounters of hospitalizations for heart failure and major edema encounters. Our findings highlight the need to weigh the benefits and risks of sodium zirconium cyclosilicate and patiromer in routine clinical practice.

BACKGROUND

Sodium zirconium cyclosilicate (SZC) and patiromer (PAT) are potassium binders that differ by exchange ion, sodium, and calcium, respectively. There are limited data on whether using sodium exchange could affect the risks of hospitalizations for heart failure (HHF) or severe edema in patients with hyperkalemia. The goal of this study was to assess the occurrence rates of prespecified major encounters potentially related to electrolyte-/fluid-related imbalances (including HHF, edema) among new users of PAT or SZC.

METHODS

Using Cerner Real World Data, we conducted a retrospective cohort study among adults (≥18 years) who were newly initiated on SZC or PAT between June 1, 2018, and December 31, 2021. Based on baseline demographic and clinical characteristics, one PAT initiator was propensity score matched with two SZC initiators. Primary outcomes were any HHF, primary HHF, major edema encounter, or death. Cox proportional hazard regression models were used to estimate the association between SZC or PAT use and each outcome in the overall population and subgroups with/without prior heart failure (HF).

RESULTS

The final cohort included 9929 PAT initiators matched to 19, 849 SZC initiators. The mean age was 66 years; about 50% had a history of CKD stages 3–5 and 34% a history of HF. Incidence rates were significantly higher in the SZC cohort when compared with the PAT cohort for all outcomes. Risks of HHF (any/primary) (adjusted hazard ratios [HRs], 1.373; 95% confidence interval [CI], 1.337 to 1.410), major edema encounter (HR, 1.330; 95% CI, 1.298 to 1.363), and death (HR, 1.287; 95% CI, 1.255 to 1.320) were also significantly higher in the SZC cohort compared with the PAT cohort ( < 0.05). These findings were consistent among subgroups with/without prior HF.

CONCLUSIONS

SZC use (versus PAT) was associated with an increased risk of prespecified encounters that were potentially sodium-/fluid-related, including among patients with/without preexisting HF.

摘要

要点

一项之前使用索赔数据的研究报告称,使用钠交换钾结合剂的患者出现心力衰竭和严重水肿住院率升高的信号。在本研究中,使用环硅酸锆钠与预先指定的心力衰竭住院和严重水肿情况的风险增加相关。我们的研究结果强调了在常规临床实践中权衡环硅酸锆钠和帕替罗姆的益处和风险的必要性。

背景

环硅酸锆钠(SZC)和帕替罗姆(PAT)是钾结合剂,其交换离子分别为钠和钙。关于使用钠交换是否会影响高钾血症患者心力衰竭(HHF)或严重水肿住院风险的数据有限。本研究的目的是评估PAT或SZC新使用者中预先指定的与电解质/液体相关失衡(包括HHF、水肿)潜在相关的主要情况的发生率。

方法

利用Cerner真实世界数据,我们对2018年6月1日至2021年12月31日期间新开始使用SZC或PAT的成年人(≥18岁)进行了一项回顾性队列研究。根据基线人口统计学和临床特征,一名PAT起始者与两名SZC起始者进行倾向评分匹配。主要结局为任何HHF、原发性HHF、严重水肿情况或死亡。使用Cox比例风险回归模型估计SZC或PAT使用与总体人群以及有/无既往心力衰竭(HF)亚组中每个结局之间的关联。

结果

最终队列包括9929名PAT起始者和19849名SZC起始者。平均年龄为66岁;约50%有3 - 5期慢性肾脏病病史,34%有HF病史。与PAT队列相比,SZC队列所有结局的发生率均显著更高。与PAT队列相比,SZC队列中HHF(任何/原发性)(调整后风险比[HRs],1.373;95%置信区间[CI],1.337至1.410)、严重水肿情况(HR,1.330;95%CI,1.298至1.363)和死亡(HR,1.287;95%CI,1.255至1.320)的风险也显著更高(<0.05)。这些发现在有/无既往HF的亚组中是一致的。

结论

使用SZC(与PAT相比)与预先指定的潜在与钠/液体相关情况的风险增加相关,包括有/无既往HF的患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a870/11687973/1df4f1609c57/kidney360-5-1835-g001.jpg

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