1,200 individuals (average age 62.7 years, 19.8% women) were randomized. The median follow-up was 39.6 months. Starting from a mean baseline value of 4.01 mmol/L, mean potassium levels of 4.36 mmol/L were achieved in the treatment group after 6 months, compared with 4.05 mmol/L in the control group.
The primary endpoint occurred significantly less often in the treatment group (22.7%) than in the control group (29.2%) (HR 0.76; 95% CI [0.61; 0.95] p=0.015). This effect was consistent across all predefined subgroups, including ischemic heart disease and heart failure. The main reason for the difference were ICD therapies (shock therapy/antitachycardia pacing, 15.3% vs. 20.3%; HR 0.75; 95% CI [0.57; 0.80]), fewer unplanned hospitalizations due to arrhythmias (6.7% vs. 10.7%; HR 0.63; 95% CI [0.28; 0.64]) and fewer for heart failure (3.5% vs. 5.5%; HR 0.62; 95% CI [0.37; 1.11]). Mortality was lower in the treatment group (5.7% vs. 6.8%; HR 0.85; 95% CI [0.54; 1.34]).
The safety analysis showed that hospitalizations due to hyperkalaemia or hypokalaemia occurred in 1% of individuals in both groups. Overall, unplanned hospitalizations (>24 hours) and deaths from any cause occurred in 29.5% vs. 33.2% (HR 0.88; 95% CI [0.72; 1.08]).