What is the indication for Finerenone (Finerenone) in adults with type 2 diabetes?

Finerenone Indication in Adults with Type 2 Diabetes

Finerenone is indicated for adults with type 2 diabetes and chronic kidney disease (CKD) who have persistent albuminuria (ACR ≥30 mg/g) despite maximum tolerated doses of renin-angiotensin system inhibitors (RASi), with eGFR ≥25 mL/min/1.73 m² and normal serum potassium concentration. 1, 2

Primary Indication and Patient Selection

• Finerenone is specifically indicated for patients with type 2 diabetes who have CKD with albuminuria (>30 mg/g) despite maximum tolerated dose of RASi therapy 1
• Eligible patients must have eGFR ≥25 mL/min/1.73 m² and normal serum potassium concentration before initiation 1
• Finerenone is most appropriate for patients at high risk of CKD progression and cardiovascular events, as demonstrated by persistent albuminuria despite standard-of-care therapies 1

Clinical Benefits

• Finerenone reduces the risk of CKD progression with a 23% reduction in composite kidney outcomes (kidney failure, sustained ≥57% decrease in eGFR, or renal death) 3, 2
• It provides significant cardiovascular protection with a 13% reduction in primary cardiovascular endpoints (cardiovascular death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure) 1, 3
• The cardiovascular benefit is primarily driven by a 29% reduction in heart failure hospitalizations 3
• Finerenone also reduces albuminuria in patients with type 2 diabetes and CKD 2

Dosing Recommendations

• For patients with eGFR 25-60 mL/min/1.73 m², the recommended starting dose is 10 mg once daily 1, 3
• For patients with eGFR >60 mL/min/1.73 m², the recommended starting dose is 20 mg once daily 1, 3
• Dose can be uptitrated to 20 mg daily if serum potassium remains <4.8 mmol/L after 4 weeks 1

Monitoring and Safety Considerations

• Serum potassium should be <4.8 mmol/L before initiation and monitored regularly during treatment 1
• If potassium increases to >5.5 mmol/L, finerenone should be withheld and can be restarted at 10 mg daily when potassium is ≤5.0 mmol/L 1
• While hyperkalemia risk is increased with finerenone (14% vs. 6.9% with placebo), the risk of severe hyperkalemia requiring drug discontinuation is relatively low (1.7% vs. 0.6%) 1, 2
• No deaths due to hyperkalemia were reported in clinical trials over 3 years of follow-up 2

Therapeutic Positioning

• KDOQI guidelines prioritize SGLT2 inhibitors over finerenone as the next step after baseline ACEi/ARB therapy due to larger effects on reducing both kidney and cardiovascular outcomes 1
• However, finerenone should be considered if a patient does not tolerate an SGLT2 inhibitor or remains with albuminuria despite being on an SGLT2 inhibitor 1
• Finerenone may be added to a RASi and an SGLT2i for treatment of type 2 diabetes and CKD in adults for complementary cardiorenal protection 1, 3

Common Pitfalls and Caveats

• Hyperkalemia is the most common adverse effect; select patients with consistently normal serum potassium and monitor regularly after initiation 1
• Finerenone should be used with caution in patients already on ACE inhibitors or ARBs due to increased hyperkalemia risk 3
• Finerenone was approved for the treatment of CKD in patients with type 2 diabetes in the United States in July 2021 and in the European Union in February 2022 1
• High medication cost may be a barrier to access, as the US patent for finerenone does not expire until 2029 1