Positive results have been announced from a phase 3 trial evaluating finerenone (Kerendia) to reduce the risk of cardiovascular death and heart failure in patients with a symptomatic heart failure diagnosis, Bayer said in a release.1 The trial is part of the company’s MOONRAKER clinical program, which is expected to be among the largest studying heart failure to date.
Results from the FINEARTS-HF (NCT04435626) trial showed that finerenone met its primary endpoint of reduction of the composite of cardiovascular death and total heart failure events up to 42 months. Key secondary endpoints being evaluated in the study include time to total heart failure events, change in total symptom score, time to occurrence of composite renal endpoint, and time to death from any cause.
About FINEARTS-HF
Trial Name: 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%
Clinicaltrials.gov Identifier: NCT04435626
Sponsor: Bayer
Summary: The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
Finerenone is a non-steroidal selective mineralocorticoid receptor antagonist. It was previously approved by the FDA in 2021 to reduce the risk of cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, sustained eGFR decline, and end-stage kidney disease in adult patients with chronic kidney disease associated with type 2 diabetes. Data supporting that approval were published in The New England Journal of Medicine.2
READ MORE: GLP-1 Use and Risk of Cardiovascular Events in Different Patient Populations
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven phase 3 study assessing the efficacy and safety of finerenone “for the reduction of risk of cardiovascular death and heart failure events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction of ≥40%, measured by local imaging measurement within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization.”
The study cohort included 6016 patients 40 years of age and older who were randomly assigned to receive either up to 40 mg finerenone once daily or placebo. Aside from meeting its primary endpoint, the therapy also demonstrated no new safety signals compared with previous studies. The most common adverse events, which were reported more frequently in the therapy group, were hyperkalemia, hypotension, and hyponatremia.
Bayer said that the data from the FINEARTS-HF clinical trial will be presented at the European Society of Cardiology (ESC) Congress 2024 in September. The company also said that it intends to discuss submission for regulatory approval of finerenone to reduce the risk of cardiovascular death and heart failure in patients with symptomatic heart failure with the FDA.
“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, head of research and development at Bayer’s pharmaceuticals division, said in a release.1
READ MORE: Cardiology Resource Center
Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.
References
2. Bakris GL, Agarwal R, Anker SD, et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23. PMID: 33264825.
