RX Review: Updates and Unmet Needs in HFmrEF/HFpEF—The Role of Finerenone - Episode 1
Finerenone Offers New Hope for HFpEF: Insights from the FINEARTS-HF Trial
Finerenone's FDA approval marks a breakthrough in heart failure treatment, significantly reducing cardiovascular events and hospitalizations for patients.
In July 2025, the cardiology community welcomed a first-in-class approval with the potential to usher in a paradigm shift for the management of heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) with the US Food and Drug Administration (FDA) approval of finerenone (Kerendia), a nonsteroidal mineralocorticoid receptor antagonist (nsMRA) from Bayer Pharmaceuticals.
In this 4-part HCPLive Rx Review, Stephen Greene, MD, sat down with Muthiah Vaduganathan, MD, MPH, and Andrew Sauer, MD, to discuss the evolving treatment landscape for HFpEF and HFmrEF.
In the first segment, the discussion focuses on the pivotal FINEARTS-HF trial led by Vaduganathan, who served as investigator on the phase 3 trial. The trial enrolled over 6000 patients with an ejectrion fraction of 40% or more, randomizing them to finerenone or placebo. Over a median follow-up of 2.7 years, finerenone significantly reduced the composite primary endpoint of cardiovascular death or total heart failure events by 16% (rate ratio [RR], 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = .007). This effect was driven primarily by reductions in hospitalizations (RR, 0.82; 95% CI, 0.71 to 0.94; P = .006).
Vaduganathan noted the safety profile was consistent with previous trials: a mild increase in potassium, a predictable dip in eGFR, and a modest blood pressure reduction of about 3 mmHg. These findings reinforce finerenone’s role as a nonsteroidal MRA that can be safely used in this population.
Greene emphasized the broader clinical impact noting that, together with SGLT2 inhibitors, finerenone adds to a growing toolbox for a population long seen as difficult to treat.
Panelists:
Stephen Greene, MD, is an advanced heart failure specialist and an associate professor in the Division of Cardiology at Duke Clinical Research Institute. Greene serves as moderator for this discussion.
Muthiah Vaduganathan, MD, MPH, is a cardiologist and the codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women's Hospital. Vaduganathan also served as an investigator on the pivotal FINEARTS-HF trial.
Andrew Sauer, MD, is a cardiologist and the codirector of Cardiovascular Research as well as the executive director of the Cardiometabolic Center Alliance at Saint Luke's Health System.
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Relevant disclosures for Greene include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others. Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others. Relevant disclosures for Sauer include Boston Scientific, Medtronic, Abbott, Impulse Dynamics, Amgen Inc., Biotronik, General Prognostics, Acorai, Bayer Healthcare Pharmaceuticals, CSL Vifor, and others.
References:
Bayer. U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review. Bayer. Published July 14, 2025. Accessed July 14, 2025. https://bayer2019tf.q4web.com/news/news-details/2025/U-S--FDA-Approves-KERENDIA-finerenone-to-Treat-Patients-With-Heart-Failure-With-Left-Ventricular-Ejection-Fraction-40-Following-Priority-Review/default.aspx
Solomon SD, John J.V. McMurray, Muthiah Vaduganathan, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. New England Journal of Medicine. 2024;391(16). doi: 10.1056/nejmoa2407107
