Abstract: FR-OR090
Serum Potassium, Hyperkalemia, and the Effect of Hyperkalemia on Treatment Efficacy with Empagliflozin, Finerenone, or Both: A CONFIDENCE Trial Report
Session Information
- Late-Breaking Research Orals - 2
November 07, 2025 | Location: Grand Ballroom C, Convention Center
Abstract Time: 04:54 PM - 05:06 PM
Category: Diabetic Kidney Disease
- 702 Diabetic Kidney Disease: Clinical
Authors
- Agarwal, Rajiv, Division of Nephrology, Richard L. Roudebush VA Medical Center & Indiana; University School of Medicine, Indianapolis, Indiana, United States
- Scott, Charlie, Clinical Statistics and Analytics, Bayer US LLC, Whippany, New Jersey, United States
- Mann, Johannes F., KfH Kidney Centre, Munich, Germany
Background
Hyperkalemia is a frequent CKD complication, particularly with RAASi. CONFIDENCE investigated empagliflozin, finerenone, and their combination (COMBO) over 180 days on UACR reduction in T2D. This prespecified analysis examines their impact on serum K, determinants of hyperkalemia, and treatment efficacy in those with/without hyperkalemia.
Methods
We analyzed data from those who received ≥1 dose (n=798). Linear mixed models (LMMs) assessed changes in serum K from baseline (BL) and logistic regression evaluated odds of hyperkalemia (ie, serum K >5.5 mmol/L).
Results
Hyperkalemia occurred in 113 (14.2%) patients: 48/262 (18.3%) finerenone, 40/268 (14.9%) COMBO, and 25/266 (9.4%) empagliflozin with few discontinuations. LMM analyses showed serum K change was independently influenced by BL serum K and eGFR, and increased with finerenone or COMBO vs empagliflozin, with no difference between finerenone and COMBO. BL UACR significantly influenced K change (p=0.001 UACR × treatment interaction), predominantly with empagliflozin (Fig A).
Logistic regression provided results concordant with the LMM. Determinants of hyperkalemia (adjusted OR [aOR; 95% CI]) were BL serum K (9.23 [5.07–16.81]), BL eGFR (0.98 [0.96–0.99]), and treatment. Compared to empagliflozin, odds of hyperkalemia (aOR [95% CI]) were higher with COMBO (2.69 [1.46–4.96]; P=0.002) and finerenone (2.56 [1.42–4.59]; P=0.002). Predictors of severe hyperkalemia (K >6.0 mmol/L) were similar. Compared to those without hyperkalemia, patients with hyperkalemia showed greater % UACR reduction at day 180 across treatments (P=0.005 for hyperkalemia effect, LMM; Fig B).
Conclusion
In CONFIDENCE, BL serum K, BL eGFR, and finerenone treatment were independent determinants of hyperkalemia. Despite increased risk with finerenone, therapeutic effects were maintained, highlighting the need for careful serum K monitoring.
Funding
- Commercial Support – The study and this analysis were funded by Bayer AG, Leverkusen, Germany. Medical writing and/or editorial assistance was provided by Anna Thompson, PhD, and Melissa Ward, BA, both of Scion (a division of Prime, London, UK). This assistance was funded by Bayer AG, Wuppertal, Germany according to Good Publication Practice guidelines.