Use and safety of finerenone in a routine setting: first interim results from FINE-REAL

People with chronic kidney disease (CKD) and type 2 diabetes, both of which are increasing in prevalence, are at risk of developing other comorbidities, such as cardiovascular disease and diabetic retinopathy. Despite the recommended use of ACE inhibitors or ARBs alongside SGLT2 inhibitors and/or GLP-1 receptor agonists, people with both conditions remain at high risk of kidney failure and cardiovascular events.

Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA), is recommended for the treatment of CKD associated with type 2 diabetes, having demonstrated its efficacy in clinical trials. However, the need for real-world data remains.

The FINE-REAL study aims, therefore, to evaluate the characteristics, treatment patterns and safety of finerenone in people treated in clinical practice. It is a prospective, single-arm, non-interventional study of adults with CKD and type 2 diabetes initiated on finerenone at multiple centres across the world. Started in June 2022, the study is expected to be completed by January 2028. 

Of 566 participants enrolled by the cut-off date of 13 June 2023, 504 were included in its first interim analysis, after a median follow-up duration of 7 months. At baseline, 76.1% of participants were in the high or very high KDIGO risk categories. ACE inhibitors/ARBs were prescribed to 71.8% of participants and SGLT2 inhibitors to 46.6%. A total of 443 (87.9%) and 61 (12.1%) participants initiated finerenone at doses of 10 mg and 20 mg, respectively, and treatment was uninterrupted in 92.3% of participants.

Treatment-emergent adverse events occurred in 110 (21.8%) participants. Hyperkalaemia was reported in 25 (5.0%) participants, without any associated cases of death, dialysis or hospitalisation.

FINE-REAL is the first study of its kind to investigate the use of a nsMRA in routine clinical care in people with CKD and type 2 diabetes. Treatment discontinuation and occurrence of hyperkalaemia were low, suggesting good tolerance and adherence to treatment in this cohort. 

These findings and future data from this study, including for the assessment of retinopathy, will help inform decision-making with respect to the initiation of finerenone in this population.

The full article can be read here.