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Abstract: TH-PO359

Evaluation of Efficacy, Safety, and Treatment Patterns of Sodium Zirconium Cyclosilicate in Management of Hyperkalemia in China: An Interim Analysis (Actualize)

Session Information

Category: Fluid, Electrolytes, and Acid-Base Disorders

  • 1102 Fluid, Electrolyte, and Acid-Base Disorders: Clinical

Authors

  • Lin, Hong Li, The First Affiliated Hospital of Dalian Medical University, Dalian, China
  • Shen, Nan, The First Affiliated Hospital of Dalian Medical University, Dalian, China
  • Meng, Qingyang, The First Affiliated Hospital of Dalian Medical University, Dalian, China
  • Zhang, Lihong, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
  • Yang, Jing, Hefei First People’s Hospital, Hefei, China
  • Lin, Yong Qiang, Wenzhou Integrated Chinese and Western Medicine Hospital, Wenzhou, China
  • Liu, Xinyu, Nanyang Central Hospital, Nanyang, China
  • Cai, Xudong, Ningbo Traditional Chinese Medicine Hospital, Ningbo, China
  • Cao, Juan, Taixing People’s Hospital, Taizhou, China
  • Zhu, Qiang, Xinghua People’s Hospital, Xinghua, China
  • Luo, Xun, Hunan Provincial People's Hospital, Changsha, Hunan, China
  • Wan, Xin, The First Hospital of Nanjing, Nanjing, China
  • Wu, Henglan, The First Hospital of Jiaxing, Jiaxing, China
  • Ye, Jianming, The First People’s Hospital of Kunshan, Kunshan, China
  • Shan, Chunyan, Chu Hsien-I Memorial Hospital of Tianjin Medical University, Tianjin, China
  • Xie, Hua, Dalian Ruikaer Renal Disease Hospital, Dalian, China
  • Wu, Yifan, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
  • Cao, Yanping, Handan First Hospital, Handan, China
  • Wang, Jianmin, Linfen Central Hospital, Linfen, Shanxi, China
  • Yu, Xiaoyong, Shanxi Provincial Hospital of Chinese Medicine, Xi'an, China
  • Wang, Huimin, Liaoning Health Industry Group Bensteel General Hospital, Liaoning, China
  • He, Jingdong, Nuclear Industry 416 Hospital, Chengdu, China
  • Tian, Shaojiang, Shiyan People’s Hospital, Shiyan, China
  • Lei, Wu Feng, Qidong People’s Hospital, Qidong, China
  • Shi, Yifan, AstraZeneca Investment China Co, Medical Affairs, Shanghai, China

Group or Team Name

  • Actualize Study Group.
Background

Sodium zirconium cyclosilicate (SZC), a novel highly selective potassium binder is approved in China for the treatment of hyperkalemia (HK), a potential life-threatening electrolyte imbalance condition. This interim analysis from an ongoing multi-center, prospective, non-interventional study evaluated the efficacy, safety and treatment patterns of SZC in Chinese HK patients under real-world settings (NCT05271266).

Methods

This study included patients ≥18 years with documented HK from 40 sites in China, taking/willing to take SZC treatment. The interim analysis included patients who have completed 1 month follow-up. As per Chinese label, SZC treatment was categorized into correction phase (FAS-P1) and maintenance phase (FAS-P2); the treatment was discontinued as per HK threshold (5.3/5.5 mmol/L in most sites under real-world settings). The study evaluated changes in serum K+ (sK+) levels and incidence of adverse events (AEs).

Results

A total of 193 patients and 354 patients were enrolled in FAS-P1 and FAS-P2, respectively. With an SZC mean daily dose of 11.5g in FAS-P1, the sK+ levels reduced significantly from baseline, 5.9 mmol/L to 5.0 mmol/L (△sK+ -0.9 mmol/L), after correction phase, 51.3% and 77.8% patients showed sK+ levels between 3.5-5.0 mmol/L and 3.5-5.5 mmol/L. With an SZC median daily dose of 5g in FAS-P2, the mean sK+ levels were 5.1 mmol/L during the maintenance treatment. SZC was well tolerated with only 1.5% and 0.5% patients in FAS-P1 and FAS-P2, respectively reporting AEs with rarely severe AEs and treatment discontinuations (Table 1).

Conclusion

From the interim analysis, SZC was effective and safe in treating HK. Hence, SZC can be considered a standard treatment for acute and chronic HK in China.

Table 1 Summary of AE with SZC
Incidence Rate, per 100 person-daysFAS-P1(%)FAS-P2(%)
Any AE1.50.5
Any SAE00.2
Any AE leading to permanent drug discontinuation00
Any specific AE
Oedema00
Hypokalemia0.10

AE, adverse events; SAE, severe adverse events

Funding

  • Commercial Support – AstraZeneca Investment China, Shanghai, China