Finerenone, polypharmacy, and clinical outcomes in heart failure: pre-specified analysis from the FINEARTS-HF trial

Clinical Snapshot

Key Findings

• P Value: Pinteraction = 0.94 (indicating consistent treatment effect)

• Effect Size: Consistent reduction in primary outcome across all polypharmacy categories

• Primary Outcome: Composite of cardiovascular death and total heart failure events

• Nnt Or Sensitivity: Event rates: non-polypharmacy 10.2, polypharmacy 12.3, hyper-polypharmacy 26.1 per 100 person-years

• Confidence Interval: Not specifically reported in abstract

Clinical Application

Highly feasible in Australian practice, addresses common clinical concern about medication burden in heart failure patients Relevant to PBS prescribing patterns and RACGP guidelines for heart failure management. Supports adding finerenone despite existing polypharmacy concerns Australian patients with HFmrEF/HFpEF, particularly elderly patients with multiple comorbidities requiring polypharmacy

Abstract

AIMS: Patients with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) have a high comorbidity burden, which may necessitate numerous medications. Patients and clinicians may be hesitant about initiating another medication, especially among those already experiencing polypharmacy. This pre-specified analysis sought to examine the efficacy and safety of adding finerenone based on the concomitant medication number. METHODS: In the FINEARTS-HF trial, baseline medication use was collected in all 6001 participants with HFmrEF/HFpEF. Clinical outcomes and treatment effects were assessed by the categories of total medication count ('non-polypharmacy': ≤4 medications; 'polypharmacy': 5-9 medications; and 'hyper-polypharmacy': ≥10 medications) and as continuous variables. The primary outcome was a composite of cardiovascular death and total HF events. RESULTS: Overall (age: 72 ± 10 years; 46% women), the total number of medications at baseline ranged from 0 to 29 (mean: 8.4 ± 3.6), with 3588 (60%) meeting polypharmacy and 1878 (31%) meeting hyper-polypharmacy. Incidence rates for the primary outcome increased across medication categories: non-polypharmacy, 10.2; polypharmacy, 12.3; and hyper-polypharmacy, 26.1 per 100 person-years. The treatment benefits of finerenone in reducing the primary outcome were consistent across the spectrum of total medication count (Pinteraction = 0.94). Any serious adverse events and study drug discontinuation were not more frequent with finerenone vs placebo, regardless of polypharmacy categories. CONCLUSION: In FINEARTS-HF, >90% of patients with HFmrEF/HFpEF met the criteria for polypharmacy or hyper-polypharmacy, and these patients faced excess risks of cardiovascular events. Finerenone safely reduced cardiovascular death and total HF events across a broad range of baseline medication use.

References

1. 1.Hamatani, Y., Claggett, B. L., Kulac, I. J., Desai, A. S., Jhund, P. S., Henderson, A. D., Lam, C. S. P., Senni, M., Shah, S. J., Voors, A. A., Zannad, F., Pitt, B., Lage, A., Sundaram, J., De Sanctis, Y., Glasauer, A., McMurray, J. J. V., Solomon, S. D., & Vaduganathan, M. (2026). Finerenone, polypharmacy, and clinical outcomes in heart failure: pre-specified analysis from the FINEARTS-HF trial. European Journal of Heart Failure. https://doi.org/10.1093/ejhf/xuag030