Frontiers in pharmacology · 2026
Safety, effectiveness and treatment patterns of sodium zirconium cyclosilicate for hyperkalemia management in China: actualize study.
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Shen Nan, Zeng Xin, Xie Hua, Zhang Lihong, Yang Jing, Lin Yongqiang, Liu Xinyu, Cai Xudong, Cao Juan, Zhu Qiang, Luo Xun, Wan Xin, Wu Henglan, Ye Jianming, Shan Chunyan, Wu Yifan, Cao Yanping, Lin Yang, Yu Xiaoyong, Wang Huimin, He Jingdong, Tian Shaojiang, Wu Fenglei, Jiang Xinxin, Li Lu, Zuo Li, Wang Zhaohua, Xing Changying, Yin Xun, Zhao Jianrong, Ma Cong, Long Gang, Li Qing, Hu Yao, Shi Yifan, Lin Hongli
Аннотация
INTRODUCTION: This real-world analysis aimed to evaluate the primary endpoint safety profile and the secondary effectiveness and treatment patterns of sodium zirconium cyclosilicate (SZC) for hyperkalemia management in China, addressing the current evidence gap on SZC use in clinical practice.
METHODS: This multi-center, prospective, non-interventional cohort study enrolled patients (aged ≥18 years), including new and ongoing SZC users, from 34-sites. Treatment was categorized into correction-phase (FAS-P1) and maintenance phase (FAS-P2, new and ongoing users). The subgroup analysis was performed in patients undergoing hemodialysis (full analysis set-hemodialysis [FAS-H]). The primary objective included the safety of SZC whereas treatment patterns and effectiveness were the secondary objectives.
RESULTS: Of the 1,000 enrolled patients, 442, 878, and 474 were included in FAS-P1, FAS-P2, and FAS-H subgroups, respectively. The most frequently used SZC dosage was 5 g once-daily in FAS-P (42.1%), and FAS-P2 (37.7%). In the FAS-P1 and FAS-P2 groups, 64% and 65.4% of patients reported AEs; 26.9% and 30.8% reported SAEs. The serum potassium (sK+) was reduced from 5.8 to 5.0 mmol/L in FAS-P1. The mean "with-in" sK+ levels over 6-month was 5.1 mmol/L in FAS-P2, of which the new-user group were slightly higher vs. ongoing group of FAS-P2 with a mean sK+ of 5.2 and 5.0 mmol/L, respectively. Furthermore, SZC showed good efficacy in patients with different chronic kidney disease stage subgroups of FAS-P2.
CONCLUSION: In real-world clinical practice, no new safety issues of SZC were identified. SZC was effective in lowering sK+ levels in the correction-phase and remained stable during the maintenance-phase.
METHODS: This multi-center, prospective, non-interventional cohort study enrolled patients (aged ≥18 years), including new and ongoing SZC users, from 34-sites. Treatment was categorized into correction-phase (FAS-P1) and maintenance phase (FAS-P2, new and ongoing users). The subgroup analysis was performed in patients undergoing hemodialysis (full analysis set-hemodialysis [FAS-H]). The primary objective included the safety of SZC whereas treatment patterns and effectiveness were the secondary objectives.
RESULTS: Of the 1,000 enrolled patients, 442, 878, and 474 were included in FAS-P1, FAS-P2, and FAS-H subgroups, respectively. The most frequently used SZC dosage was 5 g once-daily in FAS-P (42.1%), and FAS-P2 (37.7%). In the FAS-P1 and FAS-P2 groups, 64% and 65.4% of patients reported AEs; 26.9% and 30.8% reported SAEs. The serum potassium (sK+) was reduced from 5.8 to 5.0 mmol/L in FAS-P1. The mean "with-in" sK+ levels over 6-month was 5.1 mmol/L in FAS-P2, of which the new-user group were slightly higher vs. ongoing group of FAS-P2 with a mean sK+ of 5.2 and 5.0 mmol/L, respectively. Furthermore, SZC showed good efficacy in patients with different chronic kidney disease stage subgroups of FAS-P2.
CONCLUSION: In real-world clinical practice, no new safety issues of SZC were identified. SZC was effective in lowering sK+ levels in the correction-phase and remained stable during the maintenance-phase.