Abstract
Risk of hyperkalemia (HK) limits the use of RAAS inhibitors (RAASi) in pts with congestive heart failure (CHF), chronic kidney disease (CKD), or diabetes. ZS-9, a nonabsorbed cation exchanger designed to preferentially entrap K + in the GI tract, significantly reduced serum K + vs placebo (PBO) over 48 hours with low rates of adverse events in CKD patients with hyperkalemia. A pre-specified subgroup analysis was conducted with CHF patients from a large Phase 3 trial of ZS-9 for HK. Pts (N=753) with K + 5.0-6.5 mmol/L were randomized (1:1:1:1:1) to ZS-9 (1.25, 2.5, 5 or 10 g) or PBO orally 3х daily for 48 hr (acute phase). At the end of this phase, pts with K + 3.5-5.0 mmol/L (n=542) were randomized 1:1 to the same ZS-9 acute phase dose or PBO once daily (QD) on Days 3-15 (extended phase); patients initially on PBO were randomized to 1.25 or 2.5g ZS-9 QD. RAASi were kept constant during the study. Serum K + in CHF pts treated with the highest ZS-9 dose (10g) was compared to PBO with an unpaired t-test. Among 753 pts, 300 (40%) had CHF at baseline (per investigator assessment), of whom 72% were on RAASi. Mean baseline K + was 5.3 mmol/L in the CHF pts. CHF pts who entered the Extended Phase (n=204) either remained on ZS-9 10g (n=26) or switched to PBO (n=23). The extended phase baseline K + was similar between groups (4.4 vs 4.5 mmol/L) and to the overall group (4.5 mmol/L ZS-9 [n=63] vs 4.4 mmol/L PBO [n=61]). On Day 15, mean K + for CHF patients on ZS-9 10g was 4.5 mmol/L vs 5.0 mmol/L for PBO (P=0.002; Fig). ZS-9 10g once daily maintained mean serum K + <5.0 mmol/L in pts with CHF despite RAASi continuation in most pts, indicating that ZS-9 permits optimal cardiorenal protection with RAASi for this population.
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