Approval date: June 2025
V:3.0
Finerenone - Switching from eplerenone or spironolactone
SUMMARY
The complementary phase III studies FIDELIO-DKD (N=5734) and FIGARO-DKD (N=7437) examined the cardiovascular (CV) and kidney outcomes of finerenone in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) at varying, yet overlapping CKD stages, receiving optimized renin-angiotensin system inhibitors. Finerenone reduced the risk of clinically important CV and kidney outcomes vs. placebo across the spectrum of CKD in patients with T2D.1
According to the FIDELIO-DKD and FIGARO-DKD study protocols, exclusion criteria included:2-3
- Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic which cannot be discontinued at least 4 weeks prior to the screening visit.
- Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association [NYHA] class II – IV) at run in visit.
In FINEARTS-HF, a phase III study in HF patients with left ventricular ejection fraction (LVEF) ≥40%, patients treated with spironolactone were only eligible to participate if they had discontinued spironolactone at least 4 weeks prior to the screening visit.4
In ARTS-HF, a phase IIb dose-finding study of finerenone vs. eplerenone in 1,066 patients with worsening chronic HFrEF and CKD, a total of 43% of patients were receiving mineralocorticoid receptor antagonist (MRA) therapy with spironolactone or eplerenone at baseline. Per study protocol, the washout period for these agents was 48 hours or 24 hours, respectively.5
This page is intended for US healthcare professionals and may contain information outside of the approved prescribing information. It is provided in response to an unsolicited request. It is not intended as an endorsement of any usage not contained in the Prescribing Information. This response should be reviewed together with the current full Prescribing Information (including Boxed Warning) and Medical Safety Summary. These materials contain the approved indications, contraindications, warnings and precautions, adverse reactions, and other important safety information for Kerendia® (Finerenone).
Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) indicated to: reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with Type 2 diabetes mellitus (T2DM); reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with Type 1 diabetes mellitus (T1DM); reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.
Literature search
A literature search of PubMed, EMBASE and internal/external databases on May 8th, 2025,using keyword search terms ‘finerenone’ AND ‘spironolactone’, OR ‘eplerenone’ AND (‘switch’ OR ‘transition’) did not retrieve any relevant publications.
Referencess
- Agarwal R, Filippatos G, Pitt B, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43(6):474-484. PMID: 35023547
- Protocol for: 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
- Protocol for: Pitt B, Filippatos G, Agarwal R, et al. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021;385(24):2252- 2263.
- Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024;391(16):1475-1485. PMID: 39225278 (and supplement)
- Filippatos G, Anker SD, Böhm M, et al. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016;37(27):2105-2114. PMID: 27130705
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