お知らせ • Nov 15
Bayer to Present New Prespecified Subgroup Analyses from Investigational Phase III FINEARTS-HF Trial in Patients with Heart Failure with LVEF =40% at AHA 2024
Bayer will present three new prespecified subgroup analyses from the pivotal Phase III FINEARTS-HF cardiovascular outcomes trial investigating KERENDIA® (finerenone) in heart failure (HF) patients with a left ventricular ejection fraction (LVEF) of =40%, in a Featured Science session at the American Heart Association (AHA) Scientific Sessions 2024, taking place in Chicago, IL, from November 16-18, 2024. KERENDIA is currently approved to reduce the risk of cardiovascular death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained eGFR decline, and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Presentations at AHA 2024 include: Effect of Finerenone on a Hierarchical Composite Endpoint Analyzed Using Win Statistics in Patients With Heart Failure and Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of FINEARTS-HF. Session: Featured Science: Getting Closer to the Summit · November 17, 2024, 08:10 am (CST) /09:10 am (EST) The primary outcomes of FINEARTS-HF were analyzed using a win ratio approach, to allow for analysis according to their clinical importance in the following order: cardiovascular death (Tier 1); total HF hospitalizations (taking account of both the number of events and time to event) (Tier 2); and total urgent HF visits (Tier 3). Efficacy and Safety of Finerenone in Patients With Heart Failure and Mildly Reduced or Preserved Ejection Fraction: A Prespecified Sex-Specific Analysis of the FINEARTS-HF Trial. Session: Featured Science: Getting Closer to the Summit · November 17, 2024, 08:20 am (CST) /09:20 am (EST) Recognizing sex-related differences in the clinical presentation, symptoms and quality of life, prognosis, and treatment response in HF, this prespecified analysis evaluated the efficacy and safety of finerenone for HF with LVEF =40% in both women and men. Finerenone and Risk of Hyperkalemia in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction. · Session: Featured Science: Getting Closer to the Summit · November 17, 2024, 08:30 am (CST) /09:30 am (EST) This prespecified analysis investigated the frequency and predictors of hyperkalemia and examined the treatment effect of finerenone, relative to placebo, on clinical outcomes based on post-randomization potassium levels. HF is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood.2 Approximately 6.7 million adults in the U.S. live with HF, of whom about 55% have a LVEF =40%.3 Despite the high prevalence, guideline-directed medical treatment options for patients with HF with LVEF =40% are limited.4 This patient group is often balancing multiple comorbidities, such as obesity, diabetes, hypertension and CKD. The FINEARTS-HF trial, a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III trial investigated the efficacy and safety of KERENDIA® (finerenone) for the reduction of risk of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) 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 primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. Approximately 6,000 patients were randomized to receive finerenone or placebo once daily for up to 42 months. Results from FINEARTS-HF, which were published in the New England Journal of Medicine and presented the European Society of Cardiology Congress earlier this year, showed the trial met its primary endpoint, achieving a 16% (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007) relative risk reduction of the composite primary endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits) compared to placebo in addition to a patients’ prescribed treatment regimen. In the FINEARTS-HF trial, no new safety signals were identified compared with those seen in previous studies with the compound.6 Serious adverse events were comparable between treatment groups, occurring in 38.7% (1,157/2,993) of the finerenone group and 40.5% (1,213/2,993) of the placebo group. Discontinuation of the trial drug for reasons other than death was similar between groups, with 20.4% (611/2,993) in the finerenone group and 20.6% (616/2,993) in the placebo group.6 Increases in creatinine and potassium levels were more frequent in patients receiving finerenone compared to placebo, with investigator-reported hyperkalemia in 9.7% (289/2,993) of finerenone-treated patients versus 4.2% (125/2,993) in the placebo group. Serum potassium levels >6 mmol/L were observed in 3% (n=86) of the finerenone group compared to 1.4% (41/2,993) in the placebo group. While hyperkalemia was more common with finerenone, it rarely led to hospitalization (0.5% [16/2,993] versus 0.2% [6/2,993] in the placebo group), and no cases resulted in death.6 With overall more than 15,000 patients, the MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF trial programs to date, and aims to establish a comprehensive body of evidence for finerenone across a broad spectrum of patients and clinical settings.7 KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) and was approved by the U.S. Food and Drug Administration (FDA) in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for HF in adults with CKD associated with T2D. In August, Bayer announced finerenone was the first-and-only non-steroidal MRA to meet a primary composite cardiovascular endpoint in a Phase III trial investigating patients with HF and LVEF =40%. In adults with CKD associated with T2D, KERENDIA has been recommended to reduce the risk of hospitalization for HF by the American Diabetes Association (ADA)8 and European Society of Cardiology (ESC).
