1. HARMONIZE
Trial design: Patients with hyperkalemia (K ≥5.1 mEq/L) were randomized in a 1:1:1:1.7 fashion to receive sodium zirconium cyclosilicate (ZS) 5 g daily, 10 g daily, 15 g daily, or placebo daily. Patients were followed for 4 weeks.
Results
(p < 0.001)
Mean K levels between days 8-29 for ZS 5, 10, 15 vs. placebo: 4.75 vs vs vs mEq/L, p < for each group vs. placebo
Patients with K <5.1 mEq/L: 80% vs. 90% vs. 94% vs. 46%, p < 0.05
Edema: 2% vs. 6% vs. 14% vs. 2%; hypokalemia: 0% vs. 10% vs. 11% vs. 0%
100 50 %
Conclusions
ZS was safe and efficacious in the treatment of asymptomatic hyperkalemia
Dose-dependent relationship in efficacy and side effects including hypokalemia was observed
Long-term safety and efficacy studies with ZS are awaited
Patients with K < days
ZS 5g
n = 45
Placebo
n = 85
ZS 10g
n = 51
ZS 15g n = 56
Kosiborod M, et al. JAMA 2014;312: