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
- Fluid, Electrolyte, Acid-Base Disorders: Clinical - I
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
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-days | FAS-P1(%) | FAS-P2(%) |
| Any AE | 1.5 | 0.5 |
| Any SAE | 0 | 0.2 |
| Any AE leading to permanent drug discontinuation | 0 | 0 |
| Any specific AE | ||
| Oedema | 0 | 0 |
| Hypokalemia | 0.1 | 0 |
AE, adverse events; SAE, severe adverse events
Funding
- Commercial Support – AstraZeneca Investment China, Shanghai, China