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用硅酸锆钠与帕替洛默治疗高钾血症患者发生心力衰竭住院的风险。

Risk of Hospitalization for Heart Failure in Patients With Hyperkalemia Treated With Sodium Zirconium Cyclosilicate Versus Patiromer.

机构信息

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Division of Kidney (Renal) Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Division of Nephrology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

出版信息

J Card Fail. 2022 Sep;28(9):1414-1423. doi: 10.1016/j.cardfail.2022.04.003. Epub 2022 Apr 22.

DOI:10.1016/j.cardfail.2022.04.003
PMID:35470055
Abstract

BACKGROUND

Sodium zirconium cyclosilicate (SZC) and patiromer were recently approved to treat hyperkalemia. Whether the initiation of SZC is associated with an increased risk of hospitalization for heart failure (HHF) compared with patiromer in routine practice remains unknown.

METHODS AND RESULTS

We conducted a new-user cohort study of nondialysis adults who initiated SZC or patiromer using Optum's de-identified Clinformatics Data Mart Database from May 2018 to September 2020. We performed propensity score matching in a variable ratio to match each SZC initiator with up to 3 patiromer initiators. The primary outcome was HHF. Cox proportional hazards regression models generated hazard ratios with 95% confidence intervals in the propensity score-matched groups. The cohort included 1126 SZC initiators and 2839 propensity score-matched patiromer initiators. The mean age was 72 years old, approximately 30% had a history of HF, and 85% had chronic kidney disease stages 3-5. The SZC group had 88 cases of HHF (incidence rate 35.8 per 100 person-years), and the patiromer group had 245 cases of HHF (incidence rate 25.1 per 100 person-years). The rate of HHF was numerically higher in the SZC initiators than patiromer initiators (hazard ratio 1.22, 95% confidence interval 0.95-1.56), but did not reach statistical significance. Results were consistent across sensitivity and subgroup analyses.

CONCLUSIONS

The initiation of SZC might be associated with an increased risk of HHF compared with patiromer in routine practice. Larger comparative studies are needed to evaluate the safety of SZC in routine practice more precisely.

摘要

背景

环硅酸锆钠(SZC)和帕替罗默最近被批准用于治疗高钾血症。在常规实践中,与帕替罗默相比,SZC 的起始治疗是否与心力衰竭(HF)住院风险增加相关仍不清楚。

方法和结果

我们使用 Optum 的去识别 Clinformatics 数据集市数据库,对 2018 年 5 月至 2020 年 9 月期间开始使用 SZC 或帕替罗默的非透析成年人进行了新用户队列研究。我们采用变量比例进行倾向评分匹配,以匹配每个 SZC 起始者与多达 3 个帕替罗默起始者。主要结局为 HFH。在倾向评分匹配组中,Cox 比例风险回归模型生成了 95%置信区间的风险比。该队列包括 1126 名 SZC 起始者和 2839 名倾向评分匹配的帕替罗默起始者。平均年龄为 72 岁,约 30%有 HF 病史,85%有慢性肾脏病 3-5 期。SZC 组有 88 例 HFH(发病率为 35.8/100 人年),帕替罗默组有 245 例 HFH(发病率为 25.1/100 人年)。与帕替罗默起始者相比,SZC 起始者的 HFH 发生率略高(风险比 1.22,95%置信区间 0.95-1.56),但未达到统计学意义。敏感性和亚组分析结果一致。

结论

在常规实践中,与帕替罗默相比,SZC 的起始治疗可能与 HFH 风险增加相关。需要更大规模的比较研究来更准确地评估 SZC 在常规实践中的安全性。

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