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HARMONIZE Summary Slide

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HARMONIZE
Mean K levels between days 8-29 for ZS 5, 10, 15 vs. placebo:4.75 vs. 4.51 vs. 4.37 vs. 5.06mEq/L,p < 0.001for each group vs.placeboPatientswith K<5.1mEq/L: 80% vs. 90% vs. 94% vs. 46%,p < 0.05Edema: 2% vs. 6% vs. 14% vs. 2%; hypokalemia: 0% vs. 10% vs. 11% vs. 0%
Trial design:Patients withhyperkalemia (K≥5.1mEq/L) wererandomized in a 1:1:1:1.7 fashion to receivesodium zirconiumcyclosilicate(ZS) 5g daily, 10 g daily, 15 gdaily,or placebo daily.Patients were followed for 4 weeks.
Results
Conclusions
(p<0.001)
50
100
%
0
Patients with K<5.1mEq/L@ 8-29 days
ZSwas safeand efficacious inthe treatmentof asymptomatichyperkalemiaDose-dependent relationship in efficacy andside effectsincluding hypokalemiawas observedLong-term safety and efficacy studies withZSare awaited
Kosiborod M, et al. JAMA2014;312:2223-33


ZS 5gn =45


Placebon =85
ZS 10gn =51
ZS 15g n=56

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HARMONIZE Summary Slide