Efficacy and Safety of Finerenone in Type 2 Diabetes: A Pooled Analysis of Trials of Heart Failure and Chronic Kidney Disease
Year: 2025
Type: article
Abstract: 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.
Source: Diabetes Care
DOI: 10.2337/dc24-1873
Authors: John W. Ostrominski, Brian L. Claggett, Zi Michael Miao, Gerasimos Filippatos, Akshay S. Desai, Pardeep S. Jhund, Alasdair Henderson, Meike Brinker, Patrick Schloemer, Prabhakar Viswanathan, Andrea Lage, Katja Rohwedder, Carolyn S.P. Lam, Michele Senni, Sanjiv J. Shah, Adriaan A. Voors, Faiez Zannad, Peter Rossing, Luis M. Ruilope, Stefan D. Anker, Bertram Pitt, Rajiv Agarwal, John J.V. McMurray, Scott D. Solomon, Muthiah Vaduganathan
Institutions: Brigham and Women's Hospital, Harvard University, National and Kapodistrian University of Athens, University of Glasgow, Bayer (Germany), National University of Singapore, National University Heart Centre Singapore, National Heart Centre Singapore, Ospedale Papa Giovanni XXIII, Northwestern University, University of Groningen, Inserm, Centre Hospitalier Régional et Universitaire de Nancy, Université de Lorraine, University of Copenhagen, Steno Diabetes Center Copenhagen, Hospital Universitario 12 De Octubre, Charité - Universitätsmedizin Berlin, University of Michigan, Indiana University School of Medicine
Language: English
Subfield: Nephrology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: Bayer
OpenAlex ID: W4408081170