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Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes
Open accessAbstract
BACKGROUND: Finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, has favorable effects on cardiorenal outcomes in patients with predominantly stage 3 or 4 chronic kidney disease (CKD) with severely elevated albuminuria and type 2 diabetes. The use of finerenone in patients with type 2 diabetes and a wider range of CKD is unclear. METHODS: (stage 1 or 2 CKD). Patients were treated with renin-angiotensin system blockade that had been adjusted before randomization to the maximum dose on the manufacturer's label that did not cause unacceptable side effects. The primary outcome, assessed in a time-to-event analysis, was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. The first secondary outcome was a composite of kidney failure, a sustained decrease from baseline of at least 40% in the eGFR, or death from renal causes. Safety was assessed as investigator-reported adverse events. RESULTS: A total of 7437 patients underwent randomization. Among the patients included in the analysis, during a median follow-up of 3.4 years, a primary outcome event occurred in 458 of 3686 patients (12.4%) in the finerenone group and in 519 of 3666 (14.2%) in the placebo group (hazard ratio, 0.87; 95% confidence interval [CI], 0.76 to 0.98; P = 0.03), with the benefit driven primarily by a lower incidence of hospitalization for heart failure (hazard ratio, 0.71; 95% CI, 0.56 to 0.90). The secondary composite outcome occurred in 350 patients (9.5%) in the finerenone group and in 395 (10.8%) in the placebo group (hazard ratio, 0.87; 95% CI, 0.76 to 1.01). The overall frequency of adverse events did not differ substantially between groups. The incidence of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone (1.2%) than with placebo (0.4%). CONCLUSIONS: Among patients with type 2 diabetes and stage 2 to 4 CKD with moderately elevated albuminuria or stage 1 or 2 CKD with severely elevated albuminuria, finerenone therapy improved cardiovascular outcomes as compared with placebo. (Funded by Bayer; FIGARO-DKD ClinicalTrials.gov number, NCT02545049.).
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In the citing paper
“Of the secondary outcomes, the most noteworthy was a 36% reduction in kidney failure: 0.9% vs. 1.3% in the placebo group (HR 0.64 [95% CI 0.41-0.995]).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [144]
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In patients with diabetic kidney disease with increased levels of albuminuria, large placebo-controlled trials have shown that renin-angiotensin system (RAS) inhibitors,3–5 sodium-glucose cotransporter 2 (SGLT2) inhibitors,6,7 and the non-steroidal mineralocorticoid receptor antagonist finerenone8,9 all reduced the risk of progression to kidney failure.”
From Empagliflozin in Patients with Chronic Kidney Disease (2023) · cites this paper as [9]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“There was a higher incidence of hyperkalemia in the finerenone group, 10.8% vs. 5.3%, although only 1.2% of the 3,686 individuals on finerenone stopped the study due to hyperkalemia.”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [126]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) outcome trial (460) demonstrates a significant relationship between reduction in moderately increased albuminuria and reduction in cardiovascular risk.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [460]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Discontinuation of trial regimen was higher among those on fi nerenone than placebo (1.2% vs. 0.4%).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [164]
Experimental — accuracy not yet measured
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“and no effect on HbA1c, no increase in hypo- or hyperglycemia, and no sexual side effects due to the speci fi city for the MRA.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [164]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Patients with T2D and albuminuria are known to be at high risk of CKD progression and cardiovascular events, and the FIDELIO-DKD and FIGARO-DKD trials demonstrated that fi nerenone reduced these events (particularly CKD progression and heart failure) among such patients.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [164]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The pooled analysis of two complementary trials comprising 13 026 patients with a broad spectrum of CKD and type 2 diabetes, all treated with an optimized dose of an ACEi or ARB,7 , 10 provides robust evidence of both cardiovascular and kidney protection with finerenone vs. placebo.”
From Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis (2022) · cites this paper as [10]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“There was a higher incidence of hyperkalemia in the finerenone group, 10.8% vs. 5.3%, although only 1.2% of the 3,686 individuals on finerenone stopped the study due to hyperkalemia.”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [144]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“People with type 2 diabetes and CKD should be considered for treatment with finerenone to reduce cardiovascular outcomes and the risk of CKD progression (239–242).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [240]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Finerenone was investigated in two complementary phase 3 studies of patients with T2D, kidney disease (defined primarily as ACR ≥30 mg/g), and potassium <4.8 mmol/L and is the only ns-MRA approved in the world for slowing CKD progression and reducing cardiovascular events.”
From Diabetes management in chronic kidney disease: a consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO) (2022) · cites this paper as [87]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“The finerenone group showed a 13% reduction in the primary end point compared with the placebo group (12.4% vs. 14.2%;HR 0.87 [95% CI 0.76-0.98];P = 0.03).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [126]
The cited source says what the claim attributes to it.
In the citing paper
“Of the secondary outcomes, the most noteworthy was a 36% reduction in ESKD: 0.9% vs. 1.3% in the placebo group (HR 0.64 [95% CI 0.41-0.995]).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [126]
The cited source says what the claim attributes to it.
In the citing paper
“This benefit was primarily driven by a reduction in heart failure hospitalizations: 3.2% vs. 4.4% in the placebo group (HR 0.71 [95% CI 0.56-0.90]).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [126]
The cited source says what the claim attributes to it.
In the citing paper
“There was a 13% lower risk of the primary cardiovascular composite outcome, which included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [164]
The cited source says what the claim attributes to it.
In the citing paper
“The secondary composite kidney outcome, which included kidney failure, sustained decrease from baseline of at least 40% in eGFR, or death from kidney causes, was not signi fi cantly different between fi nerenone and placebo (HR 0.87, 95% CI 0.76 -1.01).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [164]
The cited source says what the claim attributes to it.
In the citing paper
“On average, there was only a small reduction in systolic blood pressure (3 mm Hg) with fi nerenone compared to placebo, and no effect on HbA1c, no increase in hypo- or hyperglycemia, and no sexual side effects due to the speci fi city for the MRA.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [164]
The cited source says what the claim attributes to it.
In the citing paper
“and fi nerenone reduced the risk of kidney and cardiovascular outcomes in 2 pivotal outcome trials.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [164]
The cited source says what the claim attributes to it.
In the citing paper
“In FIGARO-DKD, finerenone significantly reduced the primary cardiovascular composite outcome risk in a broader patient population than studied in FIDELIO-DKD (patients with stage 2–4 CKD and moderately increased albuminuria, or stage 1–2 CKD with severely increased albuminuria).7 , 10”
From Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis (2022) · cites this paper as [10]
The cited source says what the claim attributes to it.
In the citing paper
“The FIDELIO-DKD trial was designed to detect a treatment effect of finerenone on kidney failure endpoints, whereas the FIGARO-DKD trial aimed to detect an effect on a cardiovascular composite primary endpoint.7 , 10”
From Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis (2022) · cites this paper as [10]
The cited source says what the claim attributes to it.
In the citing paper
“This benefit was primarily driven by a reduction in heart failure hospitalizations: 3.2% vs. 4.4% in the placebo group (HR 0.71 [95% CI 0.56-0.90]).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [144]
The cited source says what the claim attributes to it.
In the citing paper
“The finerenone group showed a 13% reduction in the primary end point compared with the placebo group (12.4% vs. 14.2%;HR 0.87 [95% CI 0.76-0.98];P = 0.03).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [144]
The cited source says what the claim attributes to it.
In the citing paper
“In the FIGARO-DKD trial, finerenone reduced the primary outcome of death from cardiovascular causes, nonfatal MI, nonfatal stroke, or hospitalization for heart failure (HR 0.87 [95% CI 0.76-0.98];P = 0.03) in people with type 2 diabetes and CKD (248).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [248]
The cited source says what the claim attributes to it.
In the citing paper
“Only 7.8% of all participants had a prior history of heart failure, and the incidence of hospitalization for heart failure was reduced in the finerenone-allocated treatment arm (HR 0.71 [95% CI 0.56-0.90]).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [248]
The cited source says what the claim attributes to it.
In the citing paper
“Only 7.8% of all participants had a prior history of heart failure, and the incidence of hospitalization for heart failure was reduced in the finerenone-allocated treatment arm (HR 0.71 [95% CI 0.56–0.90]).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [240]
The cited source says what the claim attributes to it.
In the citing paper
“In the FIGARO-DKD trial, finerenone reduced the primary outcome of death from cardiovascular causes, nonfatal MI, nonfatal stroke, or hospitalization for heart failure (HR 0.87 [95% CI 0.76–0.98]; P = 0.03) in people with type 2 diabetes and CKD (240).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [240]
The cited source says what the claim attributes to it.
In the citing paper
“In summary, FIDELIO-DKD and FIGARO-DKD demonstrated cardiovascular and kidney benefits for finerenone among people with T2D who were treated with standard of care (including an RAS inhibitor at maximally tolerated doses and good control of glycemia and BP) who were at high residual risk, based largely on albuminuria (ACR ≥30 mg/g).”
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“Physical activity and aerobic exercise guidelines are similar in persons with T2D independent of lean vs overweight/obese BMI.431,674,727,728”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [431]
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“Overall, the updated evidence review identifi ed 27 RCTs on MRA, with 5 RCTs comparing nonsteroidal MRA to placebo and/or standard of care.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [164]
Experimental — accuracy not yet measuredIn the citing paper
“According to two large randomized placebo-controlled trials targeted at T2DM and CKD patients, finerenone has been demonstrated to significantly reduce the occurrences of composite renal outcome”
In the citing paper
“and composite cardiovascular outcome (defined as a composite of nonfatal MI, nonfatal stroke, death from cardiovascular causes, or hospitalization for heart failure [HHF]), regardless of patients with or without established cardiovascular disease [16, 17].”
In the citing paper
“Even more recently, the non-steroidal mineralocorticoid receptor antagonist (MRA) finerenone has been shown to confer both cardiovascular and kidney protection in patients with T2D and CKD, in both a dedicated kidney outcome trial and a dedicated cardiovascular outcome trial [22,23].”
From Glucagon-like peptide-1 receptor agonists in diabetic kidney disease: a review of their kidney and heart protection (2023) · cites this paper as [23]
In the citing paper
“In FIGARO-DKD, finerenone significantly reduced the composite cardiovascular outcome, which was the primary outcome of the trial (HR: 0.87, 95% CI: 0.76-0.98).26”
In the citing paper
“FIDELIO-DKD and FIGARO-DKD each enrolled people with T2D treated with the maximum-tolerated dose of RASi who had residual albuminuria (ACR $30 mg/g [$3 mg/mmol]) and a nonelevated serum potassium (<4.8 mEq/l at screening).”
In the citing paper
“This recommendation is based on the high-quality evidence from FIDELIO-DKD and FIGARO-DKD (Grade A, summarized above) that finerenone slows progression of CKD and reduces risks of cardiovascular events in this population.25,26”
In the citing paper
“Two large clinical trials (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease [FIDELIO-DKD] 25 and Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease [FIGARO-DKD] 26 ) and a pre-specified individual-level combined analysis of these 2 trials (The FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD”
In the citing paper
“To mitigate hyperkalemia risk, the FIDELIO-DKD and FIGARO-DKD trials restricted eligibility to patients with non-elevated serum potassium concentration (after maximizing RASi) and implemented a standardized potassiummonitoring protocol.”
In the citing paper
“The HR of the primary outcome of cardiovascular death, nonfatal MI, nonfatal stroke, or hospitalization from heart failure was reduced by 13% in patients treated with fi nerenone.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2023 (2023) · cites this paper as [186]
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Metadata
- Authors
- Pitt, B., Filippatos, G., Agarwal, R., Anker, S. D., Bakris, G. L., Rossing, P., Joseph, A., Kolkhof, P., Nowack, C., Schloemer, P., & Ruilope, L. M.
- Affiliations
- National and Kapodistrian University of Athens (GR)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-12-09
- Volume
- 385
- Issue
- 24
- Pages
- 2252-2263
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3194763937
- Cited by
- 1,814
- References
- 32
- Citations by year
- 2026: 439 · 2025: 435 · 2024: 331 · 2023: 315 · 2022: 250 · 2021: 41
- FWCI
- 160.23
- Type
- journal article
- Language
- en
- Open access
- Licence
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
- National University of Singapore (submittedVersion)
- ABACUS. Repositorio de Producción Científica (Universidad Europea) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- Bayer (ClinicalTrials.gov NCT02545049)
- Topics
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Keywords
- mineralocorticoid receptor antagonists, type 2 diabetes, chronic kidney disease, cardiovascular events, heart failure hospitalization, albuminuria, renin-angiotensin system blockade, hyperkalemia, estimated glomerular filtration rate decline, renal failure, cardiorenal outcomes, FIDELIO-DKD
- MeSH terms
- Aged, Albuminuria, Mineralocorticoid Receptor Antagonists, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Hospitalization, Humans, Male, Middle Aged, Naphthyridines, Proportional Hazards Models, Renal Insufficiency, Chronic
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