Effect of Sodium Zirconium Cyclosilicate Approval on the Management of Acute Hyperkalemia in Japan: Interrupted Time Series Analysis

2026-01-01

Hiroki Shimada

Kayoko Mizuno

Koji Kawakami *

DOI：10.1159/000550435

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Introduction: The impact of the new potassium binder sodium zirconium cyclosilicate (SZC) on the real-world management of acute hyperkalemia remains unknown. The aim of this study was to evaluate changes in treatment strategies and clinical outcomes for acute hyperkalemia following the approval of SZC in Japan. Methods: We conducted a retrospective cohort study using the RWD database, a nationwide electronic medical record and claims database in Japan, including adult patients who were hospitalized with hyperkalemia (serum potassium >= 5.5 mmol/L) between April 2015 and December 2024. Using an interrupted time-series analysis, we evaluated changes in outcomes following SZC approval in April 2020. The post-approval period was stratified to distinguish the effects of the coronavirus disease 2019 (COVID-19) pandemic. The primary outcome was the monthly proportion of patients receiving renal replacement therapy (RRT). Secondary outcomes included in-hospital mortality, intensive care unit (ICU) admission, and maintenance hemodialysis initiation. Results: Overall, 38,540 hospitalizations were included. While no significant immediate change in RRT use occurred upon SZC approval, a significant decreasing trend was subsequently observed (slope change, -0.7% per month; 95% confidence interval [CI], -1.2 to -0.1%). This downward trend in RRT use was highly pronounced after the COVID-19 pandemic ended. A significant decreasing trend in ICU admissions was observed in the post-pandemic period (slope change, -4.2% per month; 95% CI, -6.6 to -1.7%). Trends of in-hospital mortality and maintenance hemodialysis initiation did not significantly change. Conclusions: Following SZC approval, a decreasing trend in the use of RRT for acute hyperkalemia was observed, along with a post-pandemic decrease in ICU admissions. These trends were not accompanied by an observable increase in in-hospital mortality or initiation of maintenance hemodialysis. Acute hyperkalemia is often a life-threatening condition that requires emergency treatment. One option for severe cases is RRT, which can rapidly remove potassium from the blood. In 2020, a new drug called SZC became available in Japan. SZC binds to potassium in the gastrointestinal tract and promotes its excretion, leading to a more rapid reduction in serum potassium levels than those from conventional agents. In this study, the real-world impact of SZC approval on treatment patterns and clinical outcomes was evaluated in patients with acute hyperkalemia. We analyzed 38,540 inpatient records from Japan between 2015 and 2024 using the RWD database, a Japanese electronic medical record database linked with administrative claims data. Analysis of treatment patterns before and after SZC approval revealed a significant decrease in RRT use. This downward trend became even more pronounced after the coronavirus disease 2019 pandemic subsided. Furthermore, the proportion of patients requiring ICU admission also decreased during this period. Importantly, this shift did not lead to an increase in in-hospital mortality or the proportion of patients requiring subsequent maintenance hemodialysis. Our findings suggest that SZC may have contributed to reducing the need for invasive treatments such as RRT and ICU admission in the management of acute hyperkalemia. This shift in clinical practice indicates that SZC may play an important role in the future treatment of patients with acute hyperkalemia.

Keywords:

Sodium zirconium cyclosilicate

Acute hyperkalemia

Interrupted time-series analysis

Effect of Sodium Zirconium Cyclosilicate Approval on the Management of Acute Hyperkalemia in Japan: Interrupted Time Series Analysis

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