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Efficacy and Safety of Sodium Zirconium Cyclosilicate for Treatment of Hyperkalemia: An 11-Month Open-Label Extension of HARMONIZE.


ABSTRACT: BACKGROUND:Sodium zirconium cyclosilicate (SZC; formerly ZS-9) is a selective potassium (K+) binder for treatment of hyperkalemia. An open-label extension (OLE) of the -HARMONIZE study evaluated efficacy and safety of SZC for ?11 months. METHODS:Patients from HARMONIZE with point-of-care device i-STAT K+ 3.5-6.2 mmol/L received once-daily SZC 5-10 g for ?337 days. End points included achievement of mean serum K+ ?5.1 mmol/L (primary) or ?5.5 mmol/L (secondary). RESULTS:Of 123 patients who entered the extension (mean serum K+ 4.8 mmol/L), 79 (64.2%) completed the study. The median daily dose of SZC was 10 g (range 2.5-15 g). The primary end point was achieved by 88.3% of patients, and 100% achieved the secondary end point. SZC was well tolerated with no new safety concerns. CONCLUSION:In the HARMONIZE OLE, most patients maintained mean serum K+ within the normokalemic range for ?11 months during ongoing SZC treatment.

SUBMITTER: Roger SD 

PROVIDER: S-EPMC6947980 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Sodium Zirconium Cyclosilicate for Treatment of Hyperkalemia: An 11-Month Open-Label Extension of HARMONIZE.

Roger Simon D SD   Spinowitz Bruce S BS   Lerma Edgar V EV   Singh Bhupinder B   Packham David K DK   Al-Shurbaji Ayman A   Kosiborod Mikhail M  

American journal of nephrology 20191028 6


<h4>Background</h4>Sodium zirconium cyclosilicate (SZC; formerly ZS-9) is a selective potassium (K+) binder for treatment of hyperkalemia. An open-label extension (OLE) of the -HARMONIZE study evaluated efficacy and safety of SZC for ≤11 months.<h4>Methods</h4>Patients from HARMONIZE with point-of-care device i-STAT K+ 3.5-6.2 mmol/L received once-daily SZC 5-10 g for ≤337 days. End points included achievement of mean serum K+ ≤5.1 mmol/L (primary) or ≤5.5 mmol/L (secondary).<h4>Results</h4>Of 1  ...[more]

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