AIMS: This prespecified analysis evaluated whether the safety and efficacy of finerenone and a sodium-glucose cotransporter 2 inhibitor (SGLT2i) combination vary by baseline glycated haemoglobin (HbA1c).
MATERIALS AND METHODS: Adults with type 2 diabetes and a urinary albumin-to-creatinine ratio (UACR) of 100 - < 5000 mg/g, estimated glomerular filtration rate (eGFR) 30-90 mL/min/1.73 m2 and HbA1c < 11% (< 97 mmol/mol) were randomised (1:1:1) to once-daily finerenone, empagliflozin or combination. Primary outcome was UACR change from baseline at Day 180.
RESULTS: Baseline HbA1c was available for 781/800 CONFIDENCE participants; baseline HbA1c and eGFR mean values (standard deviation) were 7.3% (1.2%) and 54.2 mL/min/1.73 m2 (17.1 mL/min/1.73 m2). At Day 180, HbA1c decreased with combination therapy and empagliflozin (both least-squares mean change -0.1% [95% confidence interval -0.2, -0.0]), with no change with finerenone. In total, 212, 190, 188 and 191 participants were included in HbA1c Quartiles 1 (HbA1c = 6.4% [= 46 mmol/mol]), 2 (HbA1c > 6.4 and = 7.1% [> 46 and = 54 mmol/mol]), 3 (HbA1c > 7.1 and = 7.9% [> 54 and = 63 mmol/mol]) and 4 (HbA1c > 7.9% [> 63 mmol/mol]), respectively. Change from baseline in HbA1c at Day 180 was greatest in Quartile 4. At Day 180, combination therapy reduced UACR from baseline in all HbA1c quartiles to a greater extent than either monotherapy (mean [95% CI] -53% [-63, -42], -47% [-57, -34], -63% [-70, -54] and -55% [-65, -42], in Quartiles 1-4, respectively).
CONCLUSION: Simultaneous initiation with finerenone and an SGLT2i reduced UACR compared with monotherapy and was well-tolerated irrespective of HbA1c levels.
| Discipline Area | Score |
|---|---|
| Family Medicine (FM)/General Practice (GP) |  |
| General Internal Medicine-Primary Care(US) | |
| Internal Medicine | |
| Nephrology |  |
| Endocrine | |
The article shows that simultaneous combination therapy with finerenone and empagliflozin in patients with CKD and diabetes improves glycemic control and UACR reduction. The results were observed irrespective of baseline HbA1c.
This is a fairly low-value study that describes the combination of drugs vs. either drug alone. Most clinicians already understand the concept of additive effects.
This RCT enrolled adults with type 2 diabetes, HbA1c<11% (97 mmol/mol), an eGFR of 30–90 mL/min/1.73 m², and a UACR of 100 to <5,000 mg/g. Participants were randomized to one of three treatment arms: finerenone, empagliflozin, or their combination. The combination therapy achieved the greatest reduction in UACR across all HbA1c categories. Also, there was no significant interaction between baseline HbA1c and treatment effect, indicating that the antiproteinuric benefit of combination therapy was consistent regardless of glycemic control. These findings suggest that the combination of finerenone and empagliflozin is a promising therapeutic option for enhancing kidney protection and reducing albuminuria in patients with type 2 diabetes and chronic kidney disease.
