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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.


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-?6.5?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.

SUBMITTER: Amin AN 

PROVIDER: S-EPMC6889520 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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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.

Amin Alpesh N AN   Menoyo Jose J   Singh Bhupinder B   Kim Christopher S CS  

BMC nephrology 20191202 1


<h4>Background</h4>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.<h4>Methods</h4>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,  ...[more]

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