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
BMC Nephrology Dec 07, 2019
Amin AN, et al. - In view of the requirement for reliable, timely-onset, oral treatments with an acceptable safety profile for patients with hyperkalemia, researchers investigated if sodium zirconium cyclosilicate (SZC; formerly ZS-9) treatment for ≤ 48 h would be effective as well as safe in patients with baseline serum potassium level ≥ 5.5 mmol/L. They pooled data from two phase 3 studies (ZS-003 and HARMONIZE) in patients taking SZC 10 g three times daily. At 1 h after the initial dose, they observed a reduction in the mean potassium, irrespective of baseline potassium. By 4 and 48 h, 37.5% and 85.0% of patients attained potassium level ≤ 5.0 mmol/L, respectively. Adverse events occurred in 15 patients (8.8%); none were serious. Overall, treatment with SZC 10 g three times daily resulted in serum potassium decrease and normokalemia. This treatment regimen displayed a favorable safety profile.
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