FINEARTS-HF confirms: analysis suggests premature cessation of Finerenone is associated with risk and supports long-term treatment

Withdrawal of finerenone in patients with heart failure (HF) resulted in an increased risk for cardiovascular events, data from the FINEARTS-HF trial showed. These findings support the current guidelines, which recommend the long-term use of medication for HF to maximise outcomes.

“Guidelines recommend never stopping using HF therapies such as sodium-glucose cotransporter-2 (SGLT2) inhibitors or non-steroidal mineralocorticoid receptor antagonists (nsMRA) in patients with HF with preserved ejection fraction (HFpEF),” said Dr Muthiah Vaduganathan (Brigham and Women’s Hospital, MA, USA) [1]. “However, the assumed benefit of reducing the risk for cardiovascular events or exacerbation of HF by continuing these therapies is not very well established.” The FINEARTS-HF trial randomised 6,001 patients with HFpEF or HF with mildly reduced ejection fraction (HFmrEF) 1:1 to placebo or finerenone [2]. The investigators assessed the risk for cardiovascular adverse events after withdrawal of the study drug. The median follow-up time of the double-blind phase was 2.6 years, and 3,742 participants had entered the withdrawal phase. The study team used a pre-withdrawal phase (on average 101 days) to compare the rates of cardiovascular serious adverse events, or other adverse events leading to death, on the study drug and after withdrawal.

As expected, there was no significant increased risk for adverse events in participants in the placebo arm who withdrew from the study drug (HR 1.20; 95% CI 0.60–2.41). There was, however, an increase in adverse events in participants who were treated with finerenone and withdrew from this agent (HR 2.80; 95% CI 1.44–5.45). “The interaction effect between treatment and withdrawal on adverse event rates was significant (P=0.006),” stated Dr Vaduganathan. “Furthermore, it was encouraging to see that long-term treatment with finerenone resulted in sustained reductions in cardiovascular events, even after years of treatment,” he reflected on data from the pre-withdrawal phase (HR 0.65; 95% CI 0.41–1.05).

In conclusion, the current findings of the FINEARTS-HF trial support the goal of maintaining the use of medical therapies for HF to maximise long-term gains in cardiovascular risk reduction. “The withdrawal effect that was observed for patients on finerenone was comparable to the withdrawal effect for patients on the SGLT2 inhibitor empagliflozin [3],” Dr Vaduganathan ended.

1. Vaduganathan M, et al. Blinded withdrawal of finerenone after long-term treatment in FINEARTS-HF. Hottest trials and trial updates (1), Heart Failure 2025, 17–20 May, Belgrade, Serbia.
2. Solomon SD, et al. N Engl J Med 2024;391(16):1475-1485.
3. Packer M, et al. Circulation. 2023;148(3):1011-1022.

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Posted on 17 July 202525 August 2025