Orthostatic systolic blood pressure changes in SPRINT participants at baseline

2015 
limited duration of action, while organic polymer resins such as SPS, have questionable efficacy and safety. Therefore, there is a clear need for safe and effective therapies to rapidly restore normokalemia (NK) in the acute setting and maintain normal serum K+ long-term. Sodium zirconium cyclosilicate (ZS-9) is a non-absorbed cation exchanger that selectively entraps K+ in the intestine. The objective of this analysis was to determine the time to NK among hyperkalemic patients treated with ZS-9 in the HARMONIZE trial. HARMONIZE was a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled study evaluating ZS-9 treatment in ambulatory patients with serum K+ 5.1 mEq/L. In the acute, open-label phase, all patients received 10g three times daily of ZS-9 for 48 hours, and potassium was measured at 0, 1, 2, 4, 24, and 48 hours after the first dose. The proportions of patients who achieved NK at each time point and the time to NK were estimated using Kaplan-Meier (KM) life tables. Two-sided P 0.05 was considered statistically significant. 251 hyperkalemic patients (median age 1⁄4 65 years) were included in the open-label phase analysis. The proportion of patients who remained hyperkalemic after treatment with ZS-9 steadily decreased over time (Figure). The median time to serum K+ normalization (3.5-5.0 mEq/L) was 2.2 hours. By 1, 2, 4, 24 and 48 hours post-initial treatment, 28%, 44%, 60%, 84% and 98% of patients, respectively, achieved normokalemia. Among ambulatory patients with hyperkalemia, ZS-9 rapidly lowered serum potassium levels, with a median time to normalization of 2.2 hours, and 98% of patients achieving normokalemia by 48 hours. These findings suggest that ZS-9 may be an effective and non-invasive alternative for the acute management of hyperkalemia.
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