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 FIGARO-DKD, there 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]).
“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]
Figure 2 distinguishes kidney failure from end-stage kidney disease. The claimed 0.9% versus 1.3% and hazard ratio of 0.64 are for end-stage kidney disease; kidney failure was 1.2% versus 1.7%, with a hazard ratio of 0.72 (95% CI, 0.49–1.05). (LLM, conf=0.89)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredIn patients with diabetic kidney disease and increased albuminuria, large placebo-controlled trials have shown that RAS inhibitors, SGLT2 inhibitors, and finerenone each reduced the risk of progression to kidney failure.
“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]
For the finerenone portion of the sentence, the Discussion reports fewer cases of end-stage kidney disease with finerenone than with placebo. But the Secondary and Exploratory Outcomes section says the prespecified kidney composite outcome did not differ significantly between groups; the trial therefore does not unqualifiedly establish a reduced risk of progression to kidney failure. The RAS- and SGLT2-inhibitor claims have separate citations and are not judged against this paper. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn FIGARO-DKD, 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.
“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]
The Safety Outcomes and Vital Signs section reports hyperkalemia in 10.8% of finerenone patients versus 5.3% of placebo patients, and permanent discontinuation of the trial regimen in 1.2% of finerenone patients. The Results section gives 3,686 patients in the finerenone analysis group. The paper says those patients stopped the regimen, not that they stopped participating in the study. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThe FIGARO-DKD outcome trial demonstrates a significant relationship between reduction in moderately increased albuminuria and reduction in cardiovascular risk.
“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]
The Results report a significant reduction in cardiovascular events with finerenone, and Secondary and Exploratory Outcomes report a greater reduction in urinary albumin-to-creatinine ratio than with placebo. The paper does not demonstrate a significant relationship between the *reduction in albuminuria* and the *reduction in cardiovascular risk*; it reports them as separate outcomes. The trial also included patients with severely, as well as moderately, elevated albuminuria. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIn the FIGARO-DKD trial, discontinuation of trial regimen was higher among those on finerenone than placebo (1.2% vs. 0.4%).
“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]
The Results and Safety Outcomes sections report 1.2% versus 0.4% for discontinuation specifically due to hyperkalemia, not discontinuation overall. The Patients section says overall premature discontinuation was balanced between groups (27.4% versus 27.7%). (LLM, conf=0.90)
Experimental — accuracy not yet measured
Finerenone had no effect on HbA1c, no increase in hypo- or hyperglycemia, and no sexual side effects due to the specificity for the MRA.
“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 Safety Outcomes and Vital Signs section reports similar mean glycated hemoglobin levels in the finerenone and placebo groups and equally rare gynecomastia (0.1% in each). It does not establish that there were no sexual side effects or attribute their absence to receptor specificity, and our copy does not report whether hypo- or hyperglycemia increased. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe FIDELIO-DKD and FIGARO-DKD trials demonstrated that finerenone reduced CKD progression and heart failure among patients with T2D and albuminuria.
“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]
The Discussion reports that FIDELIO-DKD improved kidney outcomes and that FIGARO-DKD’s cardiovascular benefit was driven predominantly by fewer heart-failure hospitalizations. However, the FIGARO-DKD Secondary and Exploratory Outcomes section reports no significant difference in its prespecified kidney composite outcome. The claim overstates the evidence if it means both trials demonstrated reduced CKD progression by that measure. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe pooled analysis of two 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, provides robust evidence of both cardiovascular and kidney protection with finerenone vs placebo.
“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]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn FIGARO-DKD, 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.
“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]
The Safety Outcomes and Vital Signs section reports hyperkalemia in 10.8% of the finerenone group versus 5.3% of the placebo group, and permanent discontinuation of the trial regimen in 1.2% of finerenone patients. The Results section gives 3,686 patients in the finerenone analysis group. The paper says they stopped the regimen, not that they left the study. (LLM, conf=0.86)
Experimental — accuracy not yet measuredFinerenone reduces cardiovascular outcomes and the risk of CKD progression in people with type 2 diabetes and CKD.
“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]
The Discussion reports fewer cardiovascular events with finerenone in the FIGARO-DKD trial. It also reports improved kidney outcomes in the earlier FIDELIO-DKD trial, but FIGARO-DKD did not find a statistically significant reduction in its main kidney composite outcome. The unqualified claim about reduced CKD progression therefore goes beyond this trial's primary kidney finding. (LLM, conf=0.85)
Experimental — accuracy not yet measuredFinerenone was investigated in two complementary phase 3 studies of patients with type 2 diabetes, kidney disease defined primarily as ACR ≥30 mg/g, and potassium <4.8 mmol/L.
“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]
The introduction describes two complementary phase 3 finerenone trials in patients with type 2 diabetes and CKD, and the Patients section gives an albumin-to-creatinine ratio starting at 30 mg/g for this trial. However, the Patients section specifies serum potassium of 4.8 mmol/L or less at screening, not strictly less than 4.8 mmol/L. The quoted claim also applies that threshold to both trials, which this passage does not establish. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn FIGARO-DKD, 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).
“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]
In FIGARO-DKD, there was a 36% reduction in ESKD: 0.9% vs. 1.3% (HR 0.64 [95% CI 0.41-0.995]).
“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]
In FIGARO-DKD, the benefit was primarily driven by a reduction in heart failure hospitalizations: 3.2% vs. 4.4% (HR 0.71 [95% CI 0.56-0.90]).
“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]
In the FIGARO-DKD trial, finerenone reduced the risk of the primary cardiovascular composite outcome (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) by 13% compared with placebo.
“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]
In the FIGARO-DKD trial, the secondary composite kidney outcome (kidney failure, sustained decrease from baseline of at least 40% in eGFR, or death from kidney causes) was not significantly different between finerenone and placebo (HR 0.87, 95% CI 0.76-1.01).
“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]
On average, there was only a small reduction in systolic blood pressure (3 mm Hg) with finerenone compared to placebo.
“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]
Finerenone reduced the risk of kidney and cardiovascular outcomes in 2 pivotal outcome trials.
“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]
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 chronic kidney disease and moderately increased albuminuria, or stage 1-2 chronic kidney disease with severely increased albuminuria).
“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 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.
“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]
In FIGARO-DKD, the 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]).
“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]
In FIGARO-DKD, the finerenone group showed a 13% reduction in the primary composite outcome compared with placebo (12.4% vs. 14.2%; HR 0.87 [95% CI 0.76-0.98]; P = 0.03).
“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]
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.
“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]
In FIGARO-DKD, the incidence of hospitalization for heart failure was reduced in the finerenone-allocated treatment arm (HR 0.71 [95% CI 0.56-0.90]).
“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]
In FIGARO-DKD, the incidence of hospitalization for heart failure was reduced in the finerenone-allocated treatment arm (HR 0.71 [95% CI 0.56-0.90]).
“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]
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.
“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]
FIDELIO-DKD and FIGARO-DKD demonstrated cardiovascular and kidney benefits for finerenone among people with type 2 diabetes who were treated with standard of care (including an RAS inhibitor at maximally tolerated doses and good control of glycemia and blood pressure) and who were at high residual risk, based largely on albuminuria (ACR ≥30 mg/g).
“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).”
Physical activity and aerobic exercise guidelines are similar in people with type 2 diabetes independent of lean versus overweight or obese BMI.
“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]
The Discussion reports cardiovascular outcomes of finerenone in people with type 2 diabetes and chronic kidney disease, and mentions guidelines for drug treatment. A search for physical activity, aerobic exercise, and BMI-based recommendations found no passage addressing whether exercise guidelines are the same for lean and overweight or obese people. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThe updated evidence review identified 27 RCTs on MRA, with 5 RCTs comparing nonsteroidal MRA to placebo and/or standard of care.
“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]
The Trial Design and Oversight section (page unavailable) describes a single placebo-controlled finerenone trial, not an updated evidence review. Searches for the stated totals and for a review of mineralocorticoid receptor antagonist trials found no passage reporting 27 RCTs or a subgroup of 5 RCTs. (LLM, conf=0.76)
Experimental — accuracy not yet measuredAccording to two large randomized placebo-controlled trials targeted at T2DM and CKD patients, finerenone significantly reduces the occurrence of composite renal outcome.
“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”
According to two large randomized placebo-controlled trials targeted at T2DM and CKD patients, finerenone significantly reduces the occurrence of composite cardiovascular outcome.
“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].”
Finerenone has been shown to confer both cardiovascular and kidney protection in patients with T2D and CKD in dedicated kidney and cardiovascular outcome trials.
“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 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).
“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”
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) and a nonelevated serum potassium (<4.8 mEq/l at screening).
“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).”
High-quality evidence from FIDELIO-DKD and FIGARO-DKD shows that finerenone slows progression of CKD and reduces risks of cardiovascular events in patients with T2D and CKD.
“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”
Two large clinical trials (FIDELIO-DKD and FIGARO-DKD) and a pre-specified individual-level combined analysis (FIDELITY) evaluated the benefits and risks of finerenone.
“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”
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 potassium-monitoring protocol.
“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 FIGARO-DKD, finerenone reduced the primary composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure hospitalization by 13% in patients with type 2 diabetes and CKD on maximum renin-angiotensin system blockade.
“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: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [186]
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Self-citationMineralocorticoid receptor antagonists and kidney diseases: pathophysiological basis
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Self-citationKidney Function and Outcomes in Patients Hospitalized With Heart Failure
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High-Normal Albuminuria and Risk of Heart Failure in the Community
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Self-citationMineralocorticoids in the Heart and Vasculature: New Insights for Old Hormones
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Cardiovascular Disease in Patients With CKD
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KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease
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Empagliflozin in Patients with Chronic Kidney Disease
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“…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 finerenone 8,9 all reduced the risk of progression to kidney failure.”
2024 ESC Guidelines for the management of elevated blood pressure and hypertension
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Self-citation2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes.
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Self-citationKDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease
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“0030), in a population that excluded patients with chronic symptomatic heart failure with reduced ejection fraction at the run-in visit.(7,10) This finding is important because heart failure is a major source of morbidity and healthcare costs among patients with CKD and type 2 diabetes; therefore, prevention of such e…”
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“In Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD), the primary composite cardiovascular end point (MACE or hospitalization for HF) was reduced with finerenone compared with placebo, with estimates of effect for kidney outcomes and hyperkalemia similar to those see…”
Self-citationFinerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
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Self-citationType 2 diabetes mellitus in adults: pathogenesis, prevention and therapy
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Authors/Task Force Members:, McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., et al. (2024) · European Journal of Heart Failure · doi:10.1002/ejhf.3024 · Cited by 501 · see citing works
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Self-citationTargeting inflammation to treat diabetic kidney disease: the road to 2030
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Self-citationMolecular pathways that drive diabetic kidney disease
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10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025
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11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2024
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Self-citation11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025
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Self-citationAldosterone as a Mediator of Cardiovascular Damage
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JCS/JHFS 2025 Guideline on Diagnosis and Treatment of Heart Failure
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Self-citationHypertension management in patients with cardiovascular comorbidities
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Aldosterone in chronic kidney disease and renal outcomes
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2023 Clinical Practice Guidelines for Diabetes Mellitus of the Korean Diabetes Association
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- 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 · 2020: 1 · 2019: 1
- 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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