Finerenone Indication in Adults with Type 2 Diabetes

Primary Indication and Patient Selection

• The American Journal of Kidney Diseases recommends finerenone 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
• The Kidney International guidelines indicate that eligible patients must have eGFR ≥25 mL/min/1.73 m² and normal serum potassium concentration before initiation of finerenone therapy 1, 2
• 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, according to the American Journal of Kidney Diseases 1

Clinical Benefits

• The Diabetes Care guidelines state that finerenone provides significant cardiovascular protection with a 13% reduction in primary cardiovascular endpoints (cardiovascular death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure) 3, 4
• The Kidney International guidelines report that 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) 4, 5
• Finerenone also reduces albuminuria in patients with type 2 diabetes and CKD, as stated in the Praxis Medical Insights guidelines, but the American Journal of Kidney Diseases guidelines are preferred for this fact, however it is not available 5

Dosing Recommendations

• The Kidney International guidelines recommend a starting dose of 10 mg once daily for patients with eGFR 25-60 mL/min/1.73 m², and 20 mg once daily for patients with eGFR >60 mL/min/1.73 m² 2, 4
• The dose can be uptitrated to 20 mg daily if serum potassium remains <4.8 mmol/L after 4 weeks, according to the Kidney International guidelines 2

Monitoring and Safety Considerations

• The American Journal of Kidney Diseases guidelines state that serum potassium should be <4.8 mmol/L before initiation and monitored regularly during treatment 1, 2
• 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, as recommended by the Kidney International guidelines 2
• The Kidney International guidelines report that 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%) 6, 5

Therapeutic Positioning

• The 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, as stated in the American Journal of Kidney Diseases guidelines 1, 7
• However, finerenone should be considered if a patient does not tolerate an SGLT2 inhibitor or remains with albuminuria despite being on an SGLT2 inhibitor, according to the American Journal of Kidney Diseases guidelines 1, 7
• Finerenone may be added to a RASi and an SGLT2i for treatment of type 2 diabetes and CKD in adults for complementary cardiorenal protection, as recommended by the American Journal of Kidney Diseases guidelines 1, 4

Finerenone Indication in Adults with Type 2 Diabetes

Patient Selection Criteria

• The American College of Cardiology recommends finerenone for adults with type 2 diabetes and chronic kidney disease who have persistent albuminuria (≥30 mg/g) despite maximum tolerated renin-angiotensin system inhibitor therapy, with eGFR ≥25 mL/min/1.73 m² and serum potassium ≤4.8 mmol/L 8
• Finerenone may be considered for patients with type 2 diabetes and chronic kidney disease who are already on maximum tolerated dose of ACE inhibitor or ARB, with serum potassium ≤4.8 mmol/L at baseline 8

Treatment Sequencing Algorithm

• The treatment sequencing algorithm for cardiorenal protection involves maximizing RAS inhibitor, adding SGLT2 inhibitor, and then considering finerenone if albuminuria persists despite SGLT2 inhibitor therapy, with finerenone potentially added to both RAS inhibitor and SGLT2 inhibitor for complementary cardiorenal protection 8

Potassium Monitoring and Management

• The monitoring schedule for potassium levels involves checking at baseline, rechecking at 1 month after initiation, and then monitoring every 4 months during maintenance, with actions based on potassium levels including continuing current dose, monitoring every 4 months, holding finerenone, adjusting diet/medications, and restarting at 10 mg when ≤5.0 mmol/L 8

Target Population Characteristics

• Finerenone is most appropriate for patients at high risk of CKD progression and cardiovascular events, specifically those with persistent albuminuria despite optimized standard-of-care therapies, progressive kidney function decline, and history of or risk for cardiovascular events 8

Finerenone Therapy for Type 2 Diabetes and Chronic Kidney Disease

Introduction to Finerenone Benefits

• Finerenone provides dual cardiovascular and kidney protection in patients with type 2 diabetes and chronic kidney disease, reducing cardiovascular events by 14% and kidney failure by 23%, and should be added to maximally tolerated renin-angiotensin system inhibitors in patients with persistent albuminuria (≥30 mg/g) and eGFR ≥25 mL/min/1.73 m², according to the American College of Cardiology 9

Primary Cardiovascular Benefits

• Decreases heart failure hospitalizations by 29% (HR 0.71, 95% CI 0.56-0.90), with particular benefit in preventing new-onset heart failure in patients without symptomatic HFrEF, as recommended by the American Heart Association 10, 11, 12

Kidney Protection Benefits

• The American Diabetes Association recommends finerenone as it reduces composite kidney outcomes by 23% (HR 0.77, 95% CI 0.67-0.88), including kidney failure, sustained ≥57% decrease in eGFR, or renal death, in patients with type 2 diabetes and CKD, as demonstrated in the FIDELIO-DKD trial 10, 11, 12

Patient Selection Criteria

• The ideal candidates for finerenone therapy have type 2 diabetes with CKD and persistent albuminuria (UACR ≥30 mg/g) despite maximum tolerated renin-angiotensin system inhibitor therapy, and eGFR ≥25 mL/min/1.73 m² at baseline, as specified by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines 9

Combination with Other Cardioprotective Agents

• Finerenone can be used alongside other diabetes medications, such as metformin, as most trial patients were on metformin at baseline, and is compatible with SGLT2 inhibitors with potentially additive benefits for kidney protection, as endorsed by the American Heart Association 9