Dosing, treatment patterns, and safety of finerenone use in routine care: an interim analysis of the prospective, real-world, and observational FINE-REAL study

Abstract 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 pre-planned interim analysis was conducted 2 years after first participant first visit. Assessments included demographics, concomitant medications, and safety. Results Data were available for 1916 participants of median (interquartile range IQR) age 68 (59 to 74) years, 65% male, with median (IQR) follow-up of 260 (139 to 357) days. Baseline mean (standard deviation) estimated glomerular filtration rate (CKD-EPI equation) was 54 (24) mL/min/1.73 m2; median (IQR) urine albumin: creatinine ratio was 293 (86 to 783) mg/g. Prior/concomitant medications included renin − angiotensin system inhibitors (73%), sodium-glucose transport protein 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 with 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 this 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 use of finerenone in participants with CKD and T2D.