Finerenone benefits in patients with cardio-kidney-metabolic syndrome with or without history of cancer: the FINE-HEART pooled analysis.

BACKGROUND AND AIMS: In cardio-kidney-metabolic (CKM) syndrome, comorbid cancer is common due to shared risk factors and overlapping pathophysiologic mechanisms. Whether treatment of CKM conditions with the non-steroidal mineralocorticoid receptor antagonist finerenone may influence or be influenced by comorbid cancer is unknown. Hence, this study aimed to describe clinical features, outcomes, and treatment responses to finerenone in patients with CKM conditions and history of cancer. METHODS: This was a post hoc analysis of FINE-HEART, a pooled participant-level analysis of the FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials. The risks of clinical outcomes according to history of cancer and randomization to finerenone were assessed using Cox proportional hazard models and Fine-Gray subdistribution hazard models. RESULTS: Among 18 991 participants, 1389 (7.3%) had cancer history, most commonly gastrointestinal, male reproductive, renal/urinary tract, and haematologic cancers. Among those without prior cancer, 915 participants (5.2%) were reported to newly develop cancer during a median follow-up of 2.9 years. Patients with comorbid cancer more often had advanced CKM stages and a greater burden of CKM conditions. History of cancer was associated with higher risks of all-cause mortality and all-cause hospitalization. Finerenone consistently reduced all-cause death, heart failure, and all-cause hospitalization, a composite kidney outcome, major adverse cardiovascular events, and new-onset atrial fibrillation, irrespective of history of cancer. Adverse events were more frequent in patients with history of cancer, but finerenone's safety profile was consistent. CONCLUSIONS: Comorbid cancer was frequent in CKM participants and independently associated with worse outcomes, but it did not attenuate the treatment benefit of finerenone.