Risk of Hyperkalemia With Empagliflozin, Finerenone, or Both: Secondary Analysis of the CONFIDENCE Randomized Trial
Abstract
BACKGROUND
Hyperkalemia is common with renin-angiotensin system inhibitor (RASi) therapy, frequently leading to treatment interruption and potentially curtailing cardiovascular and kidney benefits. Sodium-glucose cotransporter 2 inhibitors might mitigate the risk of hyperkalemia with RASis.
OBJECTIVES
This prespecified secondary analysis of the CONFIDENCE trial aimed to investigate the impact of empagliflozin, finerenone (a nonsteroidal mineralocorticoid receptor antagonist), and their combination on hyperkalemia, and whether hyperkalemia mediates albuminuria reduction in high-risk patients with chronic kidney disease and type 2 diabetes with albuminuria.
METHODS
In this double-blind, randomized, controlled trial, CONFIDENCE, patients with type 2 diabetes, chronic kidney disease (estimated glomerular filtration rate: 30-90 mL/min/1.73 m2), and albuminuria (urine albumin-to-creatinine ratio [UACR]: 100-5,000 mg/g) on stable doses of RASis were randomized 1:1:1 to empagliflozin, finerenone, or both. The primary outcome was change in UACR from baseline to Day 180. Mean changes in potassium were estimated using linear mixed models. Logistic regression models assessed the risk of moderate (serum potassium >5.5 mmol/L) and severe (serum potassium >6.0 mmol/L) hyperkalemia. Causal mediation analysis was used to ascertain the impact of hyperkalemia on mean UACR change at Day 180.
RESULTS
Patients developing hyperkalemia had lower estimated glomerular filtration rate, higher…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 113 participants or records.
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