FINE-REAL: PROSPECTIVE PHASE IV STUDY OF FINERENONE IN CLINICAL PRACTICE. INTERIM US RESULTS

초록

FINE-REAL (NCT05348733) is a global, prospective, single-arm, noninterventional study of finerenone in participants (pts) aged ≥18 y with CKD and T2D in clinical practice. This interim analysis (cut-off 6/13/24) describes characteristics, concomitant therapy, dosing, treatment patterns, and safety of finerenone in US FINE-REAL pts. Of 774 pts (mean [SD] age, 66 [11] y), 54% were male, 1.9% aged <40 y, 19.9% Black/African American. Median (IQR) follow-up: 341 (206– 367) d. Baseline median (IQR) UACR: 200 (57–607) mg/g (n=332); mean (SD) eGFR: 52 (25) mL/min/1.73m2 (n=499). ACEi/ARB/ARNi, SGLT2i, and GLP1RA use at initiation: 71.3%, 43.0% and 32.6% of pts. 1.8%, 8.0%, 11.0%, and 18.5% were at low, moderate, high, and very high KDIGO risk. Initial finerenone dose was 10mg in 85.8% of pts and 20mg in 14.1% despite eGFR ≥60 in 28.7%. In 21.8% of pts starting on 10mg, dose was uptitrated; in 5.5% starting on 20mg, dose was downtitrated. Treatmentemergent adverse events (TEAEs) were seen in 33.5% of pts, most commonly urinary tract infection (4.0%), urogenital tract hemorrhage (3.7%), renal failure (2.2%). Serious TEAEs were seen in 8.1% of pts and study drug-related TEAEs in 9.2%. Hyperkalemia was seen in 6.8% of pts; 8 events led to study drug discontinuation; 5 were serious; 1 led to hospitalization; 0 were fatal. The FINE-REAL US cohort was at lower KDIGO risk than in finerenone Ph 3 trials, and more often received SGLT2i/GLP1RA. Finerenone was well tolerated; safety was consistent with the known profile.