Table 2.

Summary of influence of serum potassium thresholds for inclusion and uptitration limits in a FIDELIO-DKD-like simulation scenario

Hyperkalemia	Total population ≤ 4.8 mmol/L limits scenario	Total population ≤ 5.0 mmol/L limits scenario	Subset only included in ≤ 5.0 mmol/L limits scenario
> 5.5 mmol/L on finerenone (%)	20.3 (17.9–22.6)	24.0 (21.2–26.8)	51.0 (45.2–56.8)
> 5.5 mmol/L on placebo (%)	9.42 (7.99–10.9)	12.9 (11.4–14.3)	42.9 (37.7–48.0)
> 5.5 mmol/L RR (–)	2.16 (1.76–2.56)	1.87 (1.58–2.16)	1.20 (0.982–1.41)
> 6.0 mmol/L on finerenone (%)	4.50 (3.61–5.39)	5.88 (4.91–6.85)	15.0 (10.5–19.4)
> 6.0 mmol/L on placebo (%)	1.71 (1.03–2.40)	2.62 (1.77–3.48)	10.4 (6.45–14.4)
> 6.0 mmol/L RR (–)	2.75 (1.36–4.13)	2.30 (1.51–3.09)	1.49 (0.730–2.25)

The ≤ 4.8 limits scenario is like FIDELIO-DKD; the ≤ 5.0 limits scenario differs by increased inclusion and uptitration limits. The subset included with ≤ 5.0 limits but not with ≤ 4.8 limits is shown in the final column. Data are displayed as mean (95% prediction interval) of 30 iterations of the simulation. Hyperkalemia is calculated as the percentage of patients with one or more central laboratory observations > 5.5 or > 6.0 mmol/L after the baseline visit

RR relative risk or risk ratio of % patients with hyperkalemia with finerenone relative to placebo