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The following is a summary of “First interim results from FINE-REAL: a prospective, non-interventional, phase 4 study providing insights into the use and safety of finerenone in a routine clinical setting,” published in the September 2024 issue of Nephrology by Nicholas et al.
A selective non-steroidal mineralocorticoid receptor antagonist is Finerenone which enhances kidney and cardiovascular outcomes in individuals with chronic kidney disease (CKD) and type 2 diabetes (T2D).
Researchers conducted a prospective study to evaluate the characteristics and treatment patterns of individuals with CKD and T2D treated with finerenone in clinical practice.
They conducted the prospective FINE-REAL study (NCT05348733), enrolling patients initiated on finerenone as part of routine care based on country-approved labels. The study began in June 2022, with a planned completion by January 2028, and this interim analysis had a cutoff date of June 13, 2023.
The results showed that participants were recruited from nephrology, endocrinology, cardiology, and primary care settings. Of the 556 enrolled by the cutoff, 504 were included in the analysis (median follow-up of 7 months [from finerenone initiation to last observation]). The baseline of 76.1% was in high or very high (KDIGO) CKD risk categories, and 71.8% and 46.6% were prescribed angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and sodium–glucose cotransporter 2 inhibitors prescribed to 71.8% and 46.6%, respectively. Based on prescribing information, 87.9% initiated finerenone at 10 mg and 12.1% at 20 mg, with 92.3% having uninterrupted treatment after 7 months. Treatment-emergent adverse events occurred in 110 (21.8%), while hyperkalemia occurred in 25 (5.0%) participants, with no cases leading to death, dialysis, or hospitalization.
Investigators concluded that finerenone was initiated in patients with CKD and T2D across diverse clinical practices, with infrequent occurrences of treatment discontinuation and hyperkalemia.
Source: link.springer.com/article/10.1007/s40620-024-02070-y