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Efficacy and Safety of Sodium Zirconium Cyclosilicate in Patients With Baseline Serum Potassium Level ≥ 5.5 mmol/L: Pooled Analysis From Two Phase 3 Trials

Efficacy and Safety of Sodium Zirconium Cyclosilicate in Patients With Baseline Serum Potassium Level ≥ 5.5 mmol/L: Pooled Analysis From Two Phase 3 Trials

Alpesh N Amin, Jose Menoyo, Bhupinder Singh, Christopher S Kim

BMC Nephrol. 2019 Dec 2;20(1):440.

PMID: 31791288

Abstract:

Background:
Reliable, timely-onset, oral treatments with an acceptable safety profile for patients with hyperkalemia are needed. We examined the efficacy and safety of sodium zirconium cyclosilicate (SZC; formerly ZS-9) treatment for ≤ 48 h in patients with baseline serum potassium level ≥ 5.5 mmol/L.
Methods:
Data were pooled from two phase 3 studies (ZS-003 and HARMONIZE) among patients receiving SZC 10 g three times daily. Outcomes included mean and absolute change from baseline, median time to potassium level ≤ 5.5 and ≤ 5.0 mmol/L, and proportion achieving potassium level ≤ 5.5 and ≤ 5.0 mmol/L at 4, 24, and 48 h. Outcomes were stratified by baseline potassium. Safety outcomes were evaluated.
Results:
At baseline, 125 of 170 patients (73.5%) had potassium level 5.5-< 6.0, 39 (22.9%) had potassium level 6.0-6.5, and 6 (3.5%) had potassium level > 6.5 mmol/L. Regardless of baseline potassium, mean potassium decreased at 1 h post-initial dose. By 4 and 48 h, 37.5% and 85.0% of patients achieved potassium level ≤ 5.0 mmol/L, respectively. Median (95% confidence interval) times to potassium level ≤ 5.5 and ≤ 5.0 mmol/L were 2.0 (1.1-2.0) and 21.6 (4.1-22.4) h, respectively. Fifteen patients (8.8%) experienced adverse events; none were serious.
Conclusions:
SZC 10 g three times daily achieved serum potassium reduction and normokalemia, with a favorable safety profile.
Trial registration:
ClinicalTrials.gov identifiers: ZS-003: NCT01737697 and HARMONIZE: NCT02088073.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP1111732843	Potassium 3,5-dimethylisoxazole-4-trifluoroborate		1111732-84-3	Price

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