What is finerenone?

What is Finerenone

Finerenone is a nonsteroidal, selective mineralocorticoid receptor antagonist (MRA) indicated for adults with type 2 diabetes and chronic kidney disease who have persistent albuminuria despite maximum tolerated renin-angiotensin system inhibitor therapy, providing both kidney and cardiovascular protection. 1, 2

Drug Classification and Mechanism

• Finerenone is the only nonsteroidal MRA with proven clinical kidney and cardiovascular benefits, distinguishing it from traditional steroidal MRAs like spironolactone and eplerenone 1
• It selectively blocks mineralocorticoid receptors, reducing inflammation and fibrosis in both kidney and cardiac tissue 3, 4

Primary Indication and Patient Selection

Finerenone is specifically indicated for patients with type 2 diabetes and CKD who meet ALL of the following criteria: 2

• Persistent albuminuria (ACR ≥30 mg/g) despite maximum tolerated doses of ACE inhibitors or ARBs 1, 2
• eGFR ≥25 mL/min/1.73 m² 5, 2
• Serum potassium <4.8 mEq/L at baseline 5, 2

The drug should be considered for patients at high risk of CKD progression and cardiovascular events, as demonstrated by persistent albuminuria despite standard-of-care therapies 2

Dosing Strategy

Starting dose is determined by baseline eGFR: 5, 2

• 10 mg once daily if eGFR 25-60 mL/min/1.73 m² 5, 2
• 20 mg once daily if eGFR >60 mL/min/1.73 m² 5, 2

Dose titration: After 4 weeks, if serum potassium remains <4.8 mmol/L, the dose can be uptitrated to 20 mg daily 2

Clinical Benefits: Cardiovascular Outcomes

Finerenone provides substantial cardiovascular protection based on high-quality evidence from the FIDELIO-DKD and FIGARO-DKD trials: 1, 6

• 13-14% reduction in composite cardiovascular outcomes (cardiovascular death, nonfatal MI, nonfatal stroke, or heart failure hospitalization) with HR 0.86-0.87 5, 2, 6
• 29% reduction in heart failure hospitalizations (HR 0.71,95% CI 0.56-0.90) 5, 7
• These benefits were demonstrated across a broad spectrum of CKD severity in the pooled FIDELITY analysis of 13,026 patients 6

Clinical Benefits: Kidney Outcomes

Finerenone significantly slows CKD progression: 1, 2

• 23% reduction in composite kidney outcomes (kidney failure, sustained ≥57% decrease in eGFR, or renal death) with HR 0.77 2, 6
• 20% reduction in kidney failure requiring dialysis or transplantation (HR 0.80,95% CI 0.64-0.99) 1
• 36% reduction in end-stage kidney disease (HR 0.64,95% CI 0.41-0.995) 7

Therapeutic Positioning in Treatment Algorithm

The hierarchy for cardiorenal protection in type 2 diabetes with CKD is clearly established: 5, 2

1. First-line: SGLT2 inhibitors or GLP-1 receptor agonists 5
2. Second-line: Finerenone for patients with persistent albuminuria (ACR ≥30 mg/g) despite first-line therapy 5, 2

Finerenone may be added to both RAS inhibitors and SGLT2 inhibitors for complementary cardiorenal protection, though definitive data on triple therapy benefits are still emerging 2

Finerenone should be considered if a patient does not tolerate an SGLT2 inhibitor or remains with albuminuria despite being on an SGLT2 inhibitor 2

Safety Profile and Monitoring Requirements

Hyperkalemia is the primary adverse effect requiring vigilant monitoring: 5, 7

• Incidence of hyperkalemia: 10.8-14% with finerenone vs. 5.3-6.9% with placebo 5, 7
• Severe hyperkalemia requiring discontinuation occurs in only 1.2-1.7% of patients 5, 7
• No deaths related to hyperkalemia occurred in the clinical trials 7

Monitoring protocol: 5, 2

• Check serum potassium at baseline and after 4 weeks 5
• If potassium increases to >5.5 mmol/L, withhold finerenone and restart at 10 mg daily when potassium is ≤5.0 mmol/L 2

Common Pitfalls to Avoid

• Do not initiate finerenone if baseline potassium is ≥4.8 mEq/L - this is an absolute contraindication 5, 2
• Do not use in patients with eGFR <25 mL/min/1.73 m² - no evidence of benefit and increased hyperkalemia risk 5, 2
• Do not assume finerenone replaces SGLT2 inhibitors - SGLT2 inhibitors remain first-line with larger effects on kidney and cardiovascular outcomes 2
• Do not neglect to continue maximum tolerated RAS inhibitor therapy - finerenone is added to, not substituted for, RAS blockade 1, 2