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Finerenone Reduces Cardiovascular Death, HF Events in FINEARTS-HF Trial
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The investigational therapy for heart failure (HF) with mildly reduced or preserved injection fraction met its primary end point in the phase 3 trial, Bayer announced.
Patients with heart failure with mildly reduced or preserved injection fraction who received finerenone (Kerendia) experienced a statistically significant reduction in a composite end point of cardiovascular death and total heart failure events in the phase 3 FINEARTS-HF trial (NCT04435626), Bayer announced in a press release.1
The new topline results were announced ahead of the European Society of Cardiology Congress 2024 in September, where data from the FINEARTS-HF study will be presented, according to the press release. Bayer also plans to discuss a submission for regulatory approval with the FDA. No new safety signals were seen in the trial compared with previous studies of finerenone.
Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist (MRA), is the first MRA to reach a primary cardiovascular end point in a phase 3 study in heart failure with mildly reduced or preserved injection fraction. | Image credit: Robert-stock.adobe.com
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multi-center phase 3 study that is part of the MOONRAKER program, which encompasses several studies of finerenone and is one of the largest heart failure study programs to date. The FINEARTS-HF trial’s main end point was a statistically significant reduction in composite cardiovascular deaths and total heart failure events—including first and recurrent events—defined as hospitalizations for heart failure or urgent heart failure visits.
In the trial, approximately 6000 patients received once-daily finerenone or a placebo for up to 42 months.2 Patients were at least 40 years old, had heart failure with left ventricular ejection fraction (LVEF) of at least 40% with LVEF measured within the last 12 months, and were on diuretic treatment for a minimum of 30 days prior to receiving finerenone or placebo. Other inclusion criteria included structural heart abnormalities based on local imaging within the past 12 months and n-terminal prohormone B-type natriuretic peptide (NT-proBNP) of at least 300 pg/mL (BNP ≥ 100 pg/mL) in sinus rhythm and no ongoing diagnosis of paroxysmal atrial fibrillation or NT-proBNP of 900 pg/mL or higher (BNP ≥ 300 pg/mL) in atrial fibrillation within 90 days of randomization for patients who were hospitalized or had an urgent visit for heart failure or within 30 days for patients who had not been hospitalized for heart failure in the past 90 days.
The most common adverse reactions reported in at least 1% of patients in 2 placebo-controlled trials were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3.9%), and hyponatremia (1.3% vs 0.7%).1
Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist (MRA), is the first MRA to reach a primary cardiovascular end point in a phase 3 study in this patient population, which includes individuals with heart failure and LVEF greater than 40%. While its use for heart failure is investigational, finerenone is already FDA approved for the treatment of adult patients with type 2 diabetes–associated chronic kidney disease (CKD) to reduce the risk of cardiovascular death, nonfatal myocardial infarction, hospitalization for heart failure, sustained estimated glomerular filtration rate decline, and end-stage kidney disease.3
In the US, an estimated 6.7 million adults have heart failure, and about 55% of these patients have an LVEF of at least 40%.1 Still, there is a lack of treatments for these patients. In this population, many individuals also have multiple comorbidities, including obesity, high blood pressure, and CKD.
“Bayer is determined to drive research and innovations that have the potential to become treatment options for diseases with high unmet medical need, including for patients with mildly reduced or preserved ejection fraction,” Christian Rommel, MD, head of research and development at Bayer’s Pharmaceuticals Division, said in a statement.
References
1. Bayer announces primary endpoint achieved in phase III FINEARTS-HF cardiovascular outcomes study investigating Kerendia (finerenone) in patients with heart failure with mildly reduced or preserved ejection fraction. News release. August 5, 2024. Accessed August 8, 2024. https://www.bayer.com/en/us/news-stories/study-investigating-kerendiar-in-patients-with-heart-failure
3. Study to evaluate the efficacy (effect on disease) and safety of finerenone on morbidity (events indicating disease worsening) & mortality (death rate) in participants with heart failure and left ventricular ejection fraction (proportion of blood expelled per heart stroke) greater or equal to 40% (FINEARTS-HF). ClinicalTrials.gov. Updated July 3, 2024. Accessed August 9, 2024. https://clinicaltrials.gov/study/NCT04435626
3. Kerendia (finerenone). Prescribing information. FDA; 2022. Accessed August 8, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215341s001lbl.pdf
