Bayer to present three new analyses from FINEARTS-HF evaluating frequency and predictors of hyperkalemia, the effect of finerenone in women and men, and using a win-ratio approach
Not intended for U.S. and UK Media – American Heart Association (AHA) Scientific Sessions 2024:
A new analysis of FINEARTS-HF evaluated the efficacy of finerenone using a win ratio approach to assess a combined measure of important health outcomes in heart failure patients with mildly reduced or preserved ejection fraction / An additional analysis of FINEARTS-HF examined the frequency and predictors of hyperkalemia in the same trial population / A prespecified sex-specific analysis of FINEARTS-HF evaluated the efficacy and safety of finerenone in women and men / Data presented also include an analysis from FIDELITY, the prespecified pooled analysis of more than 13,000 patients from the Phase III studies FIGARO-DKD and FIDELIO-DKD, on air pollution exposure and the effect of finerenone treatment in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)
Berlin, November 13, 2024 – Bayer announced today that three new analyses from the Phase III FINEARTS-HF trial evaluating finerenone (Kerendia™) in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥ 40%, as well as data from the pooled analysis FIDELITY in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) will be presented at the American Heart Association (AHA) Scientific Sessions 2024.
Data being presented at AHA 2024 include:
Clinical benefits of finerenone in HF with LVEF of ≥ 40% analyzed with win statistics
The components of the primary outcome 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).
o Session: Featured Science: Getting Closer to the Summit: New HFpEF Treatments
o November 17, 2024, 08:10 – 08:20 am (CT) / 15:10 – 15:20 pm (CET)
Finerenone and risk of hyperkalemia in HF with LVEF of ≥ 40%
This 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.
o Session: Featured Science: Getting Closer to the Summit: New HFpEF Treatments
o November 17, 2024, 08:30 – 08:40 am (CT) / 15:30 – 15:40 pm (CET)
Clinical benefit of finerenone in women and men with HF with LVEF of ≥ 40%
Recognizing sex-related differences in the clinical presentation, symptoms and quality of life, prognosis, and treatment response in heart failure (HF), this analysis evaluated the efficacy and safety of finerenone for HF in both women and men.
o Session: Featured Science: Getting Closer to the Summit: New HFpEF Treatments
o November 17, 2024, 08:20 – 08:30 am (CT) / 15:20 – 15:30 pm (CET)
Air pollution exposure and effect of finerenone in CKD associated with T2D
Exposure to particulate matter air pollution is established as the world’s leading environmental risk factor and is implicated in cardiovascular and kidney events. This poster is based on an analysis from the prespecified pooled analysis FIDELITY of more than 13,000 patients from the Phase III studies FIGARO-DKD and FIDELIO-DKD, evaluating air pollution exposure and the effect of finerenone treatment in patients with chronic kidney disease associated with type 2 diabetes.
o Session: Abstract Poster session “Translating the Concept of CKM Syndrome to Real-World Populations”
o November 17, 2024, 03:15 – 04:15pm (CT) / 22:15 – 23:15pm (CET)
About Kerendia™ (finerenone) / Firialta™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.
Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is not approved for the treatment of heart failure.
The study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD, respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, and the Phase II study CONFIDENCE.
About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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Dr. Daniela Esser Cardiology |
