A recent prespecified analysis of the FINEARTS-HF trial revealed that oral finerenone significantly reduced the incidence of new-onset diabetes in patients with heart failure.
In the study, published in The Lancet, researchers evaluated the efficacy of finerenone, a mineralocorticoid receptor antagonist (MRA), compared with placebo on the development of new-onset diabetes in 6,001 participants with heart failure and left ventricular ejection fraction (LVEF) between September 14, 2020, and January 10, 2023. This risk has previously been reported as 40% or higher.
The researchers found that the risk of developing diabetes decreased by 24% in the finerenone group compared with placebo. This reduction represented "a meaningful additional clinical benefit of this treatment," wrote lead study author Jawad H. Butt, MD, of the British Heart Foundation Cardiovascular Research Centre at the University of Glasgow, and colleagues.
Participants were excluded if they had diabetes at baseline, defined as either a history of diabetes or HbA1c levels of at least 6.5%. The analysis focused instead on the development of new-onset diabetes, defined as an HbA1c measurement of 6.5% or higher on two consecutive follow-up visits or initiation of glucose-lowering therapy.
The results showed that, during a median follow-up of 31.3 months, 7.2% of the participants in the finerenone group developed new-onset diabetes compared with 9.1% of those in the placebo group. This translated to a rate of 3.0 events per 100 person-years in the finerenone group compared with 3.9 events per 100 person-years in the placebo group.
The hazard ratio (HR) for new-onset diabetes was 0.76 (95% confidence interval [CI] = 0.59–0.97), which indicated a 24% reduction in risk with finerenone (P = .026). This finding was supported by a Fine–Gray competing risk analysis, which yielded a similar result (subdistribution HR = 0.75 [95% CI = 0.59–0.96], P = .024).
The effect of finerenone on reducing new-onset diabetes was consistent across key subgroups, including those who had baseline glucose-lowering treatment and those with varying levels of heart failure severity. Sensitivity analyses confirmed the robustness of these findings.
"In the overall FINEARTS-HF population, finerenone reduced the risk of the primary composite outcome of total (first and repeat) worsening heart failure events and cardiovascular death, and improved health-related quality of life," the study authors wrote.
The analysis added to the growing evidence that supports finerenone as a treatment option for heart failure, especially given its potential to mitigate the risk of diabetes, a common comorbidity that exacerbates heart failure outcomes. While the decreased incidence of new-onset diabetes was clinically meaningful, the researchers stressed, the incidence was still significantly higher than in the general population.
The researchers also compared finerenone with other MRAs, such as spironolactone, which have shown conflicting effects on glycemic control. Eplerenone, another MRA, did not reduce diabetes incidence in the EMPHASIS-HF trial. The researchers also noted that that the effects of finerenone were additive with angiotensin receptor blockers and angiotensin-converting enzyme inhibitors because 80% of the participants were also receiving these therapies. The sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin has also been shown to reduce diabetes incidence in heart failure and reduced ejection fraction, but use of these agents in this study was low because enrollment and follow-up in the FINEARTS-HF trial occurred before benefits of SGLT2 inhibitors were demonstrated.
Findings from a prior large-scale randomized trial also demonstrated that finerenone reduced worsening heart failure events in patients with mildly reduced or preserved ejection fraction.
No potential conflict of interests were reported.