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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Cardiovascular and Smooth Muscle Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1398953

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)

Provisionally accepted
Nan Shen Nan Shen 1Lihong Zhang Lihong Zhang 2Jing Yang Jing Yang 3Yongqiang Lin Yongqiang Lin 4Xinyu Liu Xinyu Liu 5Xudong Cai Xudong Cai 6Juan Cao Juan Cao 7Qiang Zhu Qiang Zhu 8Xun Luo Xun Luo 9Xin Wan Xin Wan 10Henglan Wu Henglan Wu 11Jianming Ye Jianming Ye 12Chunyan Shan Chunyan Shan 13Hua Xie Hua Xie 14Yifan Wu Yifan Wu 15Yanping Cao Yanping Cao 16Jianmin Wang Jianmin Wang 17Xiaoyong Yu Xiaoyong Yu 18Huimin Wang Huimin Wang 19Jingdong He Jingdong He 20Shaojiang Tian Shaojiang Tian 21Fenglei Wu Fenglei Wu 22Xinxin Jiang Xinxin Jiang 23Lu Li Lu Li 24Li ZUO Li ZUO 25Zhaohua wang Zhaohua wang 26Chang Xing Chang Xing 27Xun Yin Xun Yin 28Jianrong Zhao Jianrong Zhao 29Cong Ma Cong Ma 30Gang Long Gang Long 31Qing Li Qing Li 32Yao Hu Yao Hu 33Yifan Shi Yifan Shi 34Hong-Li Lin Hong-Li Lin 1*
  • 1 First Affiliated Hospital, Dalian Medical University, Dalian, China
  • 2 The First hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China
  • 3 Hefei No.1 People's Hospital, Hefei, Anhui Province, China
  • 4 Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine, Zhejiang Chinese Medical University, Wenzhou, Zhejiang Province, China
  • 5 Nanyang City Center Hospital, Nanyang, China
  • 6 Ningbo Traditional Chinese Medicine Hospital, Ningbo, Zhejiang Province, China
  • 7 7Taixing People’s Hospital, Taizhou, Jiangsu, China, jiangsu, China
  • 8 Xinghua People's Hospital, xinghua, China
  • 9 Hunan Provincial People's Hospital, Changsha, Hunan Province, China
  • 10 The First Hospital of Nanjing, Nanjing, Jiangsu, China, Jiangsu, China
  • 11 The First Hospital of Jiaxing, Jiaxing, Zhejiang, China, Zhejiang, China
  • 12 The First People’s Hospital of Kunshan, Suzhou, Jiangsu, China, Jiangsu, China
  • 13 Chu Hsien-I Memorial Hospital, Tianjin Medical University, Tianjin, China
  • 14 Dalian Ruikaer Renal Disease Hospital, China, ..., China
  • 15 15Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China, Guangdong, China
  • 16 Handan First Hospital, Handan, Heibei, China, Heibei, China
  • 17 Linfen Central Hospital, Linfen, Shanxi, China, Shanxi, China
  • 18 Shanxi Provincial Hospital of Chinese Medicine, Shanxi, China, Shanxi, China
  • 19 Liaoning Health Industry Group Bensteel General Hospital, Benxi, Liaoning, China, Liaoning, China
  • 20 Nuclear Industry 416 Hospital, Chengdu, Sichuan, China, Sichuan, China
  • 21 Shiyan People’s Hospital, Shiyan, Hubei, China, Hubei, China
  • 22 Qidong People’s Hospital, The First Hospital of Tsinghua University, Beijing, China, Beijing, China
  • 23 Sandun District of Zhejiang Hospital, Zhejiang, China, Zhejiang, China
  • 24 First Affiliated Hospital of Xi'an Medical University, Xi'an, China
  • 25 Peking University People's Hospital, Beijing, Beijing Municipality, China
  • 26 Taian City Central Hospital, Tai'an, Shandong, China, Shandong, China
  • 27 Jiangsu Province Official Hospital, Nanjing, Jiangsu, China, Jiangsu, China
  • 28 Changshu No.2 People's Hospital, Suzhou, Jiangsu, China, Jiangsu, China
  • 29 The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia Autonomous Region, China
  • 30 Anshan Central Hospital, Anshan, Liaoning, China, Liaoning, China
  • 31 Tianjin People's Hospital, Tianjin, China
  • 32 Tianjin TEDA Hospital, Tianjin, China
  • 33 Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu, Sichuan, China, Sichuan, China
  • 34 AstraZeneca Investment China Co, Medical Affairs, Shanghai, China, Shanghai, China

The final, formatted version of the article will be published soon.

    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 5.8 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 48h of SZC treatment (FAS-P1:51.3%) which was maintained up to 6 months in the maintenance phase (FAS-P2:44%). SZC was welltolerated. Conclusion: SZC was effective and safe for the treatment of HK in real-world clinical practice in China.

    Keywords: Hyperkalemia, Sodium zirconium cyclosilicate, Safety, real-world clinical practice, Chinese population

    Received: 11 Mar 2024; Accepted: 12 Jul 2024.

    Copyright: © 2024 Shen, Zhang, Yang, Lin, Liu, Cai, Cao, Zhu, Luo, Wan, Wu, Ye, Shan, Xie, Wu, Cao, Wang, Yu, Wang, He, Tian, Wu, Jiang, Li, ZUO, wang, Xing, Yin, Zhao, Ma, Long, Li, Hu, Shi and Lin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Hong-Li Lin, First Affiliated Hospital, Dalian Medical University, Dalian, China

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