Efficacy and Safety of Finerenone in Type 2 Diabetes: A Pooled Analysis of Trials of Heart Failure and Chronic Kidney Disease

OBJECTIVE To evaluate the efficacy and safety of finerenone, a nonsteroidal mineralocorti-coid 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.