Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes.
Summary
In the CONFIDENCE RCT, initial combination therapy with finerenone plus empagliflozin achieved a 29–32% greater reduction in UACR at 180 days compared with either agent alone in CKD with T2D. Safety signals, including symptomatic hypotension, AKI, and hyperkalemia leading to discontinuation, were uncommon across groups.
Key Findings
- At day 180, combination therapy reduced UACR 29% more than finerenone alone (LS mean ratio 0.71; 95% CI 0.61–0.82; P<0.001).
- At day 180, combination therapy reduced UACR 32% more than empagliflozin alone (LS mean ratio 0.68; 95% CI 0.59–0.79; P<0.001).
- Symptomatic hypotension, acute kidney injury, and hyperkalemia leading to discontinuation were uncommon across all groups with no unexpected adverse events.
Clinical Implications
For patients with CKD and T2D, initiating finerenone plus an SGLT2 inhibitor may yield superior antiproteinuric effects versus monotherapy without new safety concerns, supporting earlier combination strategies alongside RAAS blockade.
Why It Matters
This trial provides high-quality randomized evidence supporting early combination cardiorenal therapy, potentially redefining treatment sequencing in CKD with diabetes.
Limitations
- Primary endpoint is a surrogate (albuminuria) rather than hard cardiorenal outcomes
- Follow-up limited to 180 days; long-term efficacy and safety not assessed
Future Directions
Evaluate long-term cardiorenal outcomes, optimal sequencing vs upfront combination, and generalizability across CKD stages and diverse populations.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized controlled trial providing high-level evidence.
- Study Design
- OTHER