Dosing, Treatment Patterns and Safety of Finerenone Use in Routine Care: an Interim Analysis of the Prospective, Real-World and Observational FINE-REAL Study.

Background:Finerenone improves cardiovascular and renal outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), but real-world data are limited. The FINE-REAL study (NCT05348733) is examining the use of finerenone (10 or 20 mg) in participants with CKD and T2D in routine clinical practice. Methods:FINE-REAL is an ongoing global, prospective, single-arm, non-interventional study. This preplanned interim analysis was conducted 2 years after the first participant first visit. Assessments included demographics, concomitant medications and safety. Results:Data were available for 1916 participants with a median age of 68 years [interquartile range (IQR) 59-74], 65% male, with a median follow-up of 260 days (IQR 139-357). The baseline mean estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration equation) was 54 ml/min/1.73 m2 (standard deviation 24) and the median urine albumin:creatinine ratio was 293 mg/g (IQR 86-783). Prior/concomitant medications included renin-angiotensin system inhibitors (73%), sodium-glucose cotransporter 2 inhibitors (53%) and glucagon-like peptide 1 receptor agonists (29%). Finerenone 10 mg/day was initiated in 1548 (81%) participants and 367 (19%) were initiated on 20 mg/day. During follow-up, 404 of the 1548 participants starting at 10 mg (26%) increased their dose to 20 mg. Finerenone was continuously administered for up to 1 year in 85% of participants, interrupted in 6% and discontinued in 13%. The most common adverse events were hyperkalaemia (8% of participants; leading to discontinuation in 1% and hospitalization in 0.3%; fatal in none), urinary tract infection (4%) and urogenital tract haemorrhage (including haematuria) (3%). Conclusions:In this real-world population, most participants initiated finerenone at 10 mg and remained on that dose. Finerenone was well tolerated and safety was consistent with the known profile of the drug. This interim analysis and future data from FINE-REAL will help to guide decision-making regarding the use of finerenone in participants with CKD and T2D.