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NON-STEROIDAL MINERALOCORTICOID RECEPTOR ANTAGONIST
Finerenone

STUDY DETAILS

Title: Effect of Finerenone on chronic kidney disease outcomes in type 2 diabetes [see Ref. 1].

Year of Publication: 2020

Journal: The New England Journal of Medicine

Study Type: Randomized, double-blind study comparing finerenone with placebo.

Sponsored by: Bayer

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Number of Patients: 5,674 (2,833 in the finerenone group and 2,841 in the placebo group)

Evaluation Period: Average of 2.6 years

Inclusion Criteria: Adults over 18 years with chronic kidney disease and type 2 diabetes, treated with an ACE inhibitor or ARB at the maximum tolerated dose; with:

  • An albumin-to-creatinine ratio of 30–300 and an eGFR of 25–60 ml/min/1.73 m² plus diabetic retinopathy, or

  • An albumin-to-creatinine ratio of 300–5000 and an eGFR of 25–75 ml/min/1.73 m²,

  • And a serum potassium level ≤4.8 mmol/L

Finerenone Group:

  • 10 mg/day if eGFR was 25–60 ml/min/1.73 m²

  • 20 mg/day if eGFR was >60 ml/min/1.73 m²

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Patient Characteristic:

  • Average age: 65.6 years

  • Finerenone group: 68.9% men  |  Placebo group: 71.5% men

  • eGFR distribution in finerenone group:

  • 2.3%: eGFR <25 ml/min  |  52.1%: eGFR 25 to <45 ml/min  |  34.3%: eGFR 45 to <60 ml/min  |  11.2%: eGFR ≥60 ml/min

  • Baseline mean eGFR (finerenone group): 44.4 ± 12.5 ml/min/1.73 m² (Stage 3b)

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RESULTS

In the finerenone group, 504 of 2,833 patients (17.8%) reached the primary composite endpoint, compared to 600 of 2,841 patients (21.1%) in the placebo group. This represents an absolute difference of 3.4% in favor of finerenone, for a composite outcome of:

  1. Kidney failure

  2. Sustained decline of at least 40% in eGFR from baseline

  3. Death from renal causes

In other terms, the finerenone group experienced 7.59 events per 100 patients per year, compared to 9.08 events in the placebo group.

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Regarding secondary outcomes, for the composite cardiovascular outcome (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure):

  • Finerenone: 13%

  • Placebo: 14.8%

Finerenone produced a 31% reduction in albumin-to-creatinine ratio from baseline to month 4 compared to placebo.

  • Renal benefits were observed after 12 months

  • Cardiovascular benefits appeared as early as 1 month

Regarding its mechanism of action, some benefits may be partially mediated through natriuretic effects. Preclinical studies showed that renal and cardiovascular benefits are associated with strong anti-inflammatory and antifibrotic effects via inhibition of the activated mineralocorticoid receptor.

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eGFR Findings

The finerenone group had an average annual decline of 2.66 ml/min/1.73 m², compared to 3.97 ml/min/1.73 m² in the placebo group.

KDIGO 2024 Guidelines

KDIGO 2024 guidelines suggest treatment with a non-steroidal mineralocorticoid receptor antagonist with proven renal or cardiovascular benefits in adults with:

  • Type 2 diabetes

  • eGFR >25 ml/min/1.73 m²

  • Normal serum potassium

  • Albuminuria >30 mg/g

These medications can be added to treatment with  renin-angiotensin system inhibitors and SGLT2 inhibitors.

Cited References

  1. Bakris GL, Agarwal R, Anker SD, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020;383(23):2219-2229. https://www.nejm.org/doi/full/10.1056/NEJMoa2025845

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