Presented by Dr Pardeep Jhund (University of Glasgow & Queen Elizabeth University Hospital, UK), the study pooled data from 3 clinical trials: FIDELIO-DKD (NCT02540993), FIGARO-DKD (NCT02545049), and FINEARTS-HF (NCT04435626), enrolling collectively 18,991 patients [1].
Although the study narrowly missed statistical significance in reducing cardiovascular deaths when excluding undetermined deaths, the sensitivity analysis that included these deaths reached significance. During a median follow-up of 2.9 years, cardiovascular deaths were reported in 421 (4.4%) patients treated with finerenone and 471 (5.0%) assigned to placebo (hazard ratio [HR] 0.89; 95% confidence interval [CI] 0.78-1.01; P=0.076). All-cause mortality was observed in 1,042 (11.0%) patients in the finerenone arm and 1,136 (12.0%) in the placebo arm (HR 0.91; 95% CI 0.84-0.99; P=0.027). Additionally, finerenone significantly reduced the risk of HF hospitalisation (HR 0.83; 95% CI 0.75-0.92; P<0.001) and the composite kidney outcome (HR 0.80; 95% CI 0.72-0.90; P<0.001) [2].
Safety assessments indicated no significant differences in adverse events related to acute kidney injury or blood pressure between the finerenone and placebo groups. Notably, while hyperkalemia was more frequent with finerenone, severe cases were rare, and hypokalemia was significantly less frequent among those treated with finerenone.
In conclusion, the FINE-HEART study supports the role of finerenone in managing complex patient profiles involving HF, chronic kidney disease, and T2D, promising a significant stride in multidisciplinary treatment approaches.
- Jhund PS, et al. Efficacy and safety of finerenone in type 2 diabetes: A pooled analysis of trials of heart failure and chronic kidney disease – FINE-HEART. LBA 06, EASD 2024, 9-13 September, Madrid, Spain.
- Vaduganathan M, et al. Nat Med. 2024, Sep 1. DOI:10.1038/s41591-024-03264-4.
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