Pooled analysis shows finerenone reduces cardio-kidney outcomes in CKM syndrome

This summary is based on the presentation of Muthiah Vaduganathan, MD (Boston, MA, US) at the ESC Congress 2024 - Finerenone in Heart Failure and Chronic Kidney Disease with Type 2 Diabetes: the FINE-HEART Pooled Analysis of Cardiovascular, Kidney, and Mortality Outcomes.

Introduction and methods

Cardiovascular-Kidney-Metabolic (CKM) syndrome has been recently recognized by the American Heart Association (AHA) as an independent syndrome, addressing the confluence of CVD, kidney disease and metabolic diseases in patients. Despite recent advancements in medical therapies, the burden of CKM syndrome remains high at the population level.

FINE-HEART was a prespecified pooled analysis of 3 phase 3 RCTs, namely FINEARTS-HF, FIDELIO-DKD, and FIGARO-DKD, that evaluated the effects of the non-steroidal MRA finerenone on cardio-kidney outcomes in patients with CKM syndrome. A total of 18,991 patients with varying combinations of HF, CKD and T2D were included in this analysis.

The primary outcome was cardiovascular mortality. Secondary endpoints were all-cause mortality, HF hospitalizations, and a kidney composite endpoint (comprising of sustained eGFR decline ≥50%, kidney failure or death due to kidney failure).

Main results

• The primary outcome occurred in 421 of patients (4.4%) in the finerenone group and in 471 of patients (5.0%) in the placebo group (HR: 0.89; 95%CI: 0.78-1.01; P=0.076).
• A large numbers of deaths could not specifically adjudicated to cardiovascular mortality versus non-cardiovascular mortality, therefore a prespecified analysis sensitivity analysis was performed, which included cardiovascular mortality and undetermined deaths. Compared with placebo, finerenone reduced cardiovascular mortality including undetermined deaths (HR: 0.88; 95%CI: 0.79-0.98; P=0.025).
• All-cause mortality was reduced in the finerenone group compared with the placebo group (HR: 0.91; 95%CI: 0.84-0.99; P=0.027).
• Compared with placebo, finerenone reduced HF hospitalizations (HR: 0.83; 95%CI: 0.75-0.92; P<0.001) and the kidney composite endpoint (HR: 0.80; 95%CI: 0.72-0.90; P<0.001).

Conclusion

In this large participant-level pooled analysis of FINEARTS-HF, FIDELIO-DKD, and FIGARO-DKD, finerenone failed to reduce cardiovascular mortality in patients with CKM syndrome compared with placebo. Finerenone significantly reduced all-cause mortality, HF hospitalizations, and kidney outcomes in patients with CKM syndrome compared with placebo. “The treatment effects were consistent across all clinically relevant subgroups, including those with multiple conditions and those previously treated with an SGLT2 inhibitor or GLP-1 receptor agonist”, added Muthiah Vaduganathan.

- Our reporting is based on the information provided at the ESC Congress 2024 -

The findings of this study were simultaneously published in Nat. Med.