Objective: To evaluate the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, in individuals with type 2 diabetes (T2D) and either chronic kidney disease (CKD) or heart failure (HF) with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF).
Research Design And Methods: In this prespecified participant-level pooled analysis of all phase III clinical trials evaluating finerenone versus placebo conducted to date (FINE-HEART), the safety and efficacy of finerenone was evaluated among participants with a history of T2D. Treatment effects on the primary outcome of cardiovascular death and other secondary outcomes were evaluated according to baseline glycated hemoglobin (HbA1c) and glucose-lowering therapy (GLT) regimen using stratified Cox proportional hazards models.
Results: Of 18,991 FINE-HEART participants, 15,365 (80.9%) had T2D and available HbA1c at baseline (mean age, 66 ± 10 years; 32% women; mean HbA1c, 7.6 ± 1.4%). The most common GLT regimens were insulin alone (n = 2,652), insulin and metformin (n = 2,005), metformin alone (n = 1,616), metformin and sulfonylurea (n = 1,039), and "other" (n = 8,117), including sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like peptide 1 receptor agonist (GLP-1RA). Over a median follow-up of 2.9 years, treatment effects of finerenone versus placebo on cardiovascular death were consistent across baseline HbA1c (Pinteraction = 0.75) and GLT regimen (Pinteraction = 0.46). Finerenone consistently reduced the kidney composite outcome, HF hospitalization, major adverse cardiovascular events, and all-cause mortality, irrespective of baseline HbA1c and GLT regimen. Treatment effects of finerenone were also consistent across number of background GLTs and irrespective of concomitant treatment with a SGLT2i or GLP-1RA.
Conclusions: Finerenone consistently reduced morbidity and mortality in individuals with T2D across a broad range of glycemia and glucose-lowering regimens.
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