Simon D Roger1, Bruce S Spinowitz2, Edgar V Lerma3, Bhupinder Singh4,5, David K Packham6, Ayman Al-Shurbaji7, Mikhail Kosiborod8,9. 1. Renal Research, Gosford, New South Wales, Australia, sdroger@bigpond.net.au. 2. Division of Nephrology, Department of Medicine, NewYork-Presbyterian Queens, New York, New York, USA. 3. Section of Nephrology, Advocate Christ Medical Center, University of Illinois at Chicago, Oak Lawn, Illinois, USA. 4. ZS Pharma, Inc., Part of AstraZeneca, San Mateo, California, USA. 5. School of Medicine, University of California, Irvine, California, USA. 6. Melbourne Renal Research Group and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia. 7. AstraZeneca, Gothenburg, Sweden. 8. Department of Cardiology, Saint Luke's Mid America Heart Institute and Department of Medicine, University of Missouri-Kansas City, Kansas City, Missouri, USA. 9. The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.
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. The Author(s). Published by S. Karger AG, Basel.
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. The Author(s). Published by S. Karger AG, Basel.
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