Finerenone in Clinical Trials for Heart Failure and Diabetic Kidney Disease
Introduction to Finerenone
- Finerenone is recommended for patients with type 2 diabetes and diabetic kidney disease at a dosage of 10-20 mg once daily to reduce the risk of progression from stage A heart failure to symptomatic incident heart failure, and to decrease cardiovascular events including hospitalization for heart failure 1, 2, 3, 4
Clinical Evidence and Trials
- The FIDELIO-DKD trial evaluated finerenone versus placebo for kidney failure, sustained decrease of ≥40% in eGFR, or death from renal causes in patients with type 2 diabetes and diabetic kidney disease 1, 5
- The FIGARO-DKD trial demonstrated that finerenone reduced the primary outcome of death from cardiovascular causes, nonfatal MI, nonfatal stroke, or hospitalization for heart failure (HR 0.87 [95% CI 0.76–0.98]; P = 0.03) 2
Dosing and Patient Selection
- The American Diabetes Association and the National Kidney Foundation recommend a starting dose of 10 mg once daily for patients with moderate CKD, with a target dose of 20 mg once daily if tolerated and no significant hyperkalemia develops 6
- Primary candidates for finerenone are patients with type 2 diabetes and diabetic kidney disease, particularly those with albuminuria (ACR ≥30 mg/g [≥3 mg/mmol]) and normal serum potassium (<4.8 mEq/l at screening) 1, 2, 3, 6
Cardiovascular and Renal Benefits
- Finerenone reduces hospitalization for heart failure (HR 0.71 [95% CI 0.56–0.90]) and the composite outcome of death from cardiovascular causes, nonfatal MI, nonfatal stroke, or hospitalization for heart failure by 13% 1, 3, 7
- Finerenone reduces kidney failure, sustained decrease in eGFR, and death from renal causes, and complements SGLT2 inhibitors in kidney protection strategy 1, 6
Combination Therapy and Safety
- The American Heart Association recommends that finerenone can be used alongside SGLT2 inhibitors with potentially additive benefits, as part of a comprehensive treatment approach that includes RAS inhibitors and metformin 6
- The European Society of Cardiology notes that hyperkalemia is the most common significant adverse effect of finerenone, requiring regular monitoring of serum potassium 6