How effective is the treatment with fenelinone?

Finerenone (Finerenone) is a new nonsteroidal mineralocorticoid receptor antagonist (MRA) associated with a lower risk of hyperkalemia than steroidal MRAs. Finelidone is approved for the purpose of delaying the progressive decline in renal function in adults with chronic kidney disease associated with type 2 diabetes mellitus and proteinuria who are already taking the maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB).

Two randomized controlled trials—FIDELIO-dk D4 and FIGARO-dk D5—compared fenelidone with placebo in adults with type 2 diabetes and diabetic nephropathy. Patients have persistent, moderate, or severe proteinuria and are receiving maximum tolerated doses of ACEI or ARB therapy. A prespecified pooled analysis of individual patient data from these trials reported results in patients with a broad range of chronic kidney disease, with a median follow-up of 3 years.

The key endpoint is composite renal and cardiovascular outcomes. The composite renal outcome occurred in 5.5% of patients treated with fenelidone and 7.1% of patients treated with placebo (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.67-0.88). The composite cardiovascular event occurred in 12.7% of patients treated with fenelidone and 14.4% of patients treated with placebo (HR 0.86; 95% CI 0.78-0.90).

Approximately14% of patients received sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists at the start of the trial. Because these drugs also have renal and cardiovascular benefits and are used as part of the management of diabetic nephropathy, a subgroup analysis was performed to explore the effect of fenelidone in patients taking and not taking these drugs. These analyzes indicate that the renal and cardiovascular benefits of fenelidone are observed regardless of whether an SGLT2 inhibitor or a GLP-1 receptor agonist is used.