Finerenone with empagliflozin in chronic kidney disease and type 2 diabetes
Open accessAbstract
BACKGROUND: Limited evidence exists to support the simultaneous initiation of sodium-glucose cotransporter-2 inhibitors and finerenone, a nonsteroidal mineralocorticoid receptor antagonist, in persons with chronic kidney disease and type 2 diabetes. METHODS: of body-surface area), albuminuria (a urinary albumin-to-creatinine ratio of 100 to ≤5000 [with albumin measured in milligrams and creatinine measured in grams]), and type 2 diabetes, who were already taking a renin-angiotensin system inhibitor, in a 1:1:1 ratio to receive finerenone (with empagliflozin-matching placebo) at a dose of 10 or 20 mg per day, empagliflozin at a dose of 10 mg per day (with finerenone-matching placebo), or a combination of finerenone and empagliflozin. The primary outcome was the relative change in the log-transformed mean urinary albumin-to-creatinine ratio from baseline to 180 days. Safety was assessed. RESULTS: At baseline, the urinary albumin-to-creatinine ratio was similar among the participants in the three groups; the median value was 579 (interquartile range, 292 to 1092) among those with available data (265 in the combination-therapy group, 258 in the finerenone group, and 261 participants in the empagliflozin group). At day 180, the reduction in the urinary albumin-to-creatinine ratio with combination therapy was 29% greater than that with finerenone alone (least-squares mean ratio of the difference in the change from baseline, 0.71; 95% confidence interval [CI], 0.61 to 0.82; P<0.001) and 32% greater than that with empagliflozin alone (least-squares mean ratio of the difference in the change from baseline, 0.68; 95% CI, 0.59 to 0.79; P<0.001). Neither agent, alone or in combination, led to unexpected adverse events. Symptomatic hypotension, acute kidney injury, and hyperkalemia leading to drug discontinuation were uncommon. CONCLUSIONS: Among persons with both chronic kidney disease and type 2 diabetes, initial therapy with finerenone plus empagliflozin led to a greater reduction in the urinary albumin-to-creatinine ratio than either treatment alone. (Funded by Bayer; CONFIDENCE ClinicalTrials.gov number, NCT05254002.).
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In the CONFIDENCE trial, simultaneous initiation of finerenone and empagliflozin led to a reduction in UACR at 180 days of 52% with combination therapy, which was 32% greater than that with empagliflozin alone and 29% greater than that with finerenone alone.
“Simultaneous initiation of finerenone and empagliflozin led to a reduction in the UACR at 180 days of 52% with combination therapy, which was 32% greater than that with empagliflozin alone and 29% greater than that with finerenone alone (148).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [148]
The Abstract reports that at day 180, the UACR reduction with initial combination therapy was 32% greater than with empagliflozin alone and 29% greater than with finerenone alone. The passages in our copy do not report the claimed 52% reduction with combination therapy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe CONFIDENCE trial provides support for initial combination therapy in the setting of type 2 diabetes and CKD to slow kidney disease progression.
“This trial provides support for initial combination therapy in the setting of type 2 diabetes and CKD to slow kidney disease progression.”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [148]
The Abstract reports that initial finerenone–empagliflozin therapy in people with type 2 diabetes and CKD reduced the urinary albumin-to-creatinine ratio more than either drug alone. That supports the combination-therapy part of the claim, but the passage reports a 180-day albuminuria outcome, not evidence that kidney disease progression was slowed. (LLM, conf=0.86)
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References 17 · Cited by 319
- Authors
- Agarwal, R., Green, J. B., Heerspink, H. J. L., Mann, J. F. E., McGill, J. B., Mottl, A. K., Rosenstock, J., Rossing, P., Vaduganathan, M., Brinker, M., Edfors, R., Li, N., Scheerer, M. F., Scott, C., & Nangaku, M.
- Affiliations
- Richard L. Roudebush VA Medical Center (US)
- Duke University (US)
- University Medical Center Groningen (NL)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- Washington University in St. Louis (US)
- University of North Carolina at Chapel Hill (US)
- Velocity Clinical Research at Medical City, Dallas
- University of Copenhagen (DK)
- Brigham and Women's Hospital (US)
- Bayer (Germany) (DE)
- Danderyds sjukhus (SE)
- Bayer (China) (CN)
- Bayer (United States) (US)
- The University of Tokyo (JP)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2025-08-07
- Volume
- 393
- Issue
- 6
- Pages
- 533-543
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4411068410
- Cited by
- 319
- References
- 17
- Citations by year
- 2026: 217 · 2025: 102
- FWCI
- 221.29
- Type
- journal article
- Language
- en
- Open access
- green
- research.rug.nl
- Licence
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- Funders
- Bayer
- Topics
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Keywords
- empagliflozin, chronic kidney disease, type 2 diabetes, SGLT2 inhibitors, mineralocorticoid receptor antagonists, combination therapy, albuminuria, albumin-creatinine ratio, renin-angiotensin system inhibitors, acute kidney injury, hyperkalemia, hypotension, drug safety
- MeSH terms
- Serum Albumin, Human, Sodium-Glucose Transporter 2 Inhibitors, Aged, Albuminuria, Mineralocorticoid Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Benzhydryl Compounds, Creatinine, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Double-Blind Method, Drug Therapy, Combination, Female, Glomerular Filtration Rate, Glucosides, Humans, Male, Middle Aged, Naphthyridines, Renal Insufficiency, Chronic
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