AUTHOR=Shen Nan , Zhang Lihong , Yang Jing , Lin Yongqiang , Liu Xinyu , Cai Xudong , Cao Juan , Zhu Qiang , Luo Xun , Wan Xin , Wu Henglan , Ye Jianming , Shan Chunyan , Xie Hua , Wu Yifan , Cao Yanping , Wang Jianmin , 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
TITLE=Effectiveness, safety, and treatment pattern of sodium zirconium cyclosilicate in Chinese patients with hyperkalemia: interim analysis from a multicenter, prospective, real-world study (Actualize Study)
JOURNAL=Frontiers in Pharmacology
VOLUME=15
YEAR=2024
URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1398953
DOI=10.3389/fphar.2024.1398953
ISSN=1663-9812
ABSTRACT=Introduction: Sodium zirconium cyclosilicate (SZC) is a nonabsorbed cation-exchanger approved in China for the treatment of hyperkalemia [HK; serum potassium (sK+) levels >5.0 mmol/L]. This is the first real-world study aimed to assess the effectiveness, safety, and treatment patterns of SZC in Chinese patients with HK. Here we present the results of the first interim analysis.
Methods: This multicenter, prospective, cohort study included patients aged ≥18 years with documented HK within 1-year before study enrollment day. These patients were followed up for 6 months from the enrollment day after initiating SZC treatment. The treatment was categorized into correction phase (FAS-P1) and maintenance phase (FAS-P2 new and ongoing users). Subgroup analysis was performed in patients on hemodialysis (FAS-H). The primary objective was evaluation of safety profile of SZC; secondary objectives included assessment of treatment patterns of SZC and its effectiveness.
Results: Of 421 screened patients, 193, 354, and 162 patients were enrolled in the FAS-P1, FAS-P2, and FAS-H groups, respectively. sK+ levels were reduced significantly from 5.9 mmol/L to 5.0 mmol/L after the correction phase. For the maintenance phase, the mean sK+ levels were maintained at 5.2 mmol/L and 5.0 mmol/L in the FAS-P2 new and ongoing user, respectively, and 5.3 mmol/L in the FAS-H subgroup. A considerable proportion of patients showed normokalemia after 48 h of SZC treatment (FAS-P1:51.3%) which was maintained up to 6 months in the maintenance phase (FAS-P2:44%). SZC was well-tolerated.
Conclusion: SZC was effective and safe for the treatment of HK in real-world clinical practice in China.