Abstract
BackgroundReliable, 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 h in patients with baseline serum potassium level ≥ 5.5 mmol/L.MethodsData 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 h. Outcomes were stratified by baseline potassium. Safety outcomes were evaluated.ResultsAt 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 h post-initial dose. By 4 and 48 h, 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) h, respectively. Fifteen patients (8.8%) experienced adverse events; none were serious.ConclusionsSZC 10 g three times daily achieved serum potassium reduction and normokalemia, with a favorable safety profile.Trial registrationClinicalTrials.gov identifiers: ZS-003: NCT01737697 and HARMONIZE: NCT02088073.
Highlights
Reliable, timely-onset, oral treatments with an acceptable safety profile for patients with hyperkalemia are needed
The current analysis examined the efficacy and safety of sodium zirconium cyclosilicate (SZC) for up to 48 h among patients with moderate to severe hyperkalemia
Patients selected for this analysis had baseline serum K+ levels ≥ 5.5 mmol/L and received SZC 10 g times daily (TID) for up to 48 h in the correction phase of either study
Summary
Timely-onset, oral treatments with an acceptable safety profile for patients with hyperkalemia are needed. Hyperkalemia is a potentially life-threatening electrolyte abnormality associated with poor clinical outcomes [1], cardiac dysrhythmias [2], increased mortality [3,4,5], and higher use of healthcare resources [1]. Hyperkalemia therapies (e.g., intravenous insulin and glucose or inhaled β2 agonists) typically used in the emergency department and other acute care settings to lower serum potassium (K+) are temporary in nature and impractical for ongoing outpatient use [6, 7]. While nonspecific cation-exchange resins (e.g., sodium polystyrene sulfonate [SPS] and patiromer) are adequately suited for the outpatient setting, they have been associated with questionable tolerability [8, 9] or a slow onset of action [6, 8, 10]. There remains a need for more reliable treatment options for patients with hyperkalemia that allow for rapid and safe reduction of K+ values
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