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 hours 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 hours. Outcomes were stratified by baseline potassium. Safety outcomes were evaluated.
Results: At baseline, 125 of 170 patients (73.5%) had potassium level 5.5–<6.0, 39 (22.9%) had potassium level 6.0–6.5, and 6 (3.5%) had potassium level >6.5 mmol/L. Regardless of baseline potassium, mean potassium decreased at 1-hour post-initial dose. By 4 and 48 hours, 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) hours, 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.
ClinicalTrials.gov identifiers: NCT01737697 and NCT02088073
FP007EFFICIENCY OF SODIUM ZIRCONIUM CYCLOSILICATE (ZS-9) INCREASES WITH SEVERITY OF HYPERKALAEMIA: SUBGROUP ANALYSIS OF PATIENTS STRATIFIED BY BASELINE POTASSIUM IN THE PHASE 3 HARMONIZE STUDY
