Finerenone in Heart Failure and Diabetic Kidney Disease
Finerenone at 10-20 mg once daily is recommended for patients with type 2 diabetes and chronic kidney disease (eGFR ≥25 mL/min/1.73 m² with persistent albuminuria ≥30 mg/g) to reduce cardiovascular death, heart failure hospitalization, and kidney disease progression, with benefits demonstrated across all stages of kidney function and albuminuria. 1, 2, 3
Key Trial Results
FIDELIO-DKD Trial
- Compared finerenone versus placebo in patients with type 2 diabetes and diabetic kidney disease for the primary outcome of kidney failure, sustained ≥40% decrease in eGFR, or death from renal causes 1, 2
- Demonstrated a 13% reduction in the prespecified secondary cardiovascular outcome (cardiovascular death, nonfatal MI, nonfatal stroke, or heart failure hospitalization) 1, 2
- Reduced heart failure hospitalization by 29% (HR 0.71,95% CI 0.56-0.90), despite only 7.7% of participants having prior heart failure history 1, 3, 4
FIGARO-DKD Trial
- Showed finerenone reduced the primary composite outcome of cardiovascular death, nonfatal MI, nonfatal stroke, or heart failure hospitalization by 13% (HR 0.87,95% CI 0.76-0.98; P = 0.03) 1, 2
- Benefits were consistent across different kidney function and albuminuria categories 5
Combined FIDELITY Analysis
- Pooled data from both trials (13,026 patients) confirmed consistent heart failure benefits across all baseline eGFR (<60 and ≥60 mL/min/1.73 m²) and UACR (<300 and ≥300 mg/g) categories 5
- Reduced first heart failure hospitalization (HR 0.78,95% CI 0.66-0.92; P = 0.003) and recurrent heart failure hospitalization (HR 0.79,95% CI 0.64-0.96; P = 0.021) 5
Dosing Algorithm
Initial Dose Selection
- eGFR 25-60 mL/min/1.73 m²: Start 10 mg once daily 2, 3, 4
- eGFR >60 mL/min/1.73 m²: Start 20 mg once daily 2, 3, 4
- Serum potassium must be <4.8 mEq/L at screening 2, 3
Dose Titration
- Check serum potassium at baseline and 4 weeks after initiation 3, 4
- Target dose is 20 mg once daily if tolerated without significant hyperkalemia 2
- Patients on 10 mg can be uptitrated to 20 mg if eGFR improves to >60 mL/min/1.73 m² and potassium remains <4.8 mEq/L 2
Patient Selection Criteria
Mandatory Requirements
- Type 2 diabetes with chronic kidney disease 1, 2, 3
- Persistent albuminuria (UACR ≥30 mg/g) despite maximum tolerated renin-angiotensin system blockade 2, 4
- eGFR ≥25 mL/min/1.73 m² 2, 3, 4
- Serum potassium <4.8 mEq/L 2, 3
Therapeutic Positioning
- Primary indication: Prevention of progression from stage A heart failure to symptomatic incident heart failure in patients with diabetic kidney disease 1
- Guideline hierarchy: SGLT2 inhibitors or GLP-1 receptor agonists are first-line for cardiorenal protection; finerenone is second-line for patients with persistent albuminuria 3
- Combination therapy: Can be used alongside SGLT2 inhibitors with potentially additive benefits 2, 3, 4
Safety Profile and Monitoring
Hyperkalemia Management
- Most common significant adverse effect with incidence of 10.8-14% versus 5.3-6.9% with placebo 3, 4
- Severe hyperkalemia requiring discontinuation occurs in only 1.2-1.7% of patients 3
- Critical monitoring points: Baseline, 4 weeks after initiation, and throughout treatment 4
Common Pitfalls to Avoid
- Do not withhold finerenone solely based on fear of hyperkalemia—the absolute risk of severe hyperkalemia is low (1.2-1.7%) and manageable with monitoring 3
- Do not use finerenone as monotherapy—it should be added to maximally tolerated RAS inhibitor therapy 4
- Do not overlook the cardiovascular benefits—the heart failure hospitalization reduction (29%) is clinically significant even in patients without prior heart failure 3, 4
Clinical Benefits Beyond Heart Failure
Kidney Protection
- Reduces kidney failure and progression to end-stage kidney disease by 36% (HR 0.64,95% CI 0.41-0.995) 4
- Complements SGLT2 inhibitors in comprehensive kidney protection strategy 2