Risk of Hyperkalemia With Empagliflozin, Finerenone, or Both: Secondary Analysis of the CONFIDENCE Randomized Trial
Authors' conclusion
Over 180 days, the combination of empagliflozin and finerenone did not significantly mitigate the risk of hyperkalemia. The treatment effect was maintained regardless of development of hyperkalemia.
Study context
- Population
- Patients with T2DM, CKD (eGFR 30–90 mL/min/1.73 m²) and albuminuria (UACR 100–5,000 mg/g) on stable renin-angiotensin system inhibitor (RASi) doses
- Participants
- 265 / 255 / 259
- Comparison
- Empagliflozin + finerenone vs finerenone vs empagliflozin
- Combinationn = 265
- Finerenonen = 255reference
- Empagliflozinn = 259
- Primary endpoint
- Hyperkalemia (moderate: serum potassium >5.5 mmol/L; severe: >6.0 mmol/L) and change in serum potassium
- Follow-up
- 180 days
Methodological detailsprespecified, double-blind, 1:1:1 randomisation
- Prespecified
- Double-blind
- 1:1:1 randomisation
Primary result
As reported in the abstract
Hyperkalemia
Combination vs Finerenone: P = 0.85 · Combination vs Finerenone: P = 0.91
- Hyperkalemia overall
- 113 patients (14.5%)
Further findings
Mediation of UACR reduction by hyperkalemia · Day 180
- Hyperkalemia not in the causal pathway of UACR reduction
Treatment discontinuations
- Few treatment discontinuations
Original publication
Risk of Hyperkalemia With Empagliflozin, Finerenone, or Both: Secondary Analysis of the CONFIDENCE Randomized Trial. J Am Coll Cardiol. Published 7 November 2025. doi:10.
Summarised from the published abstract; every number is checked against it