WHIPPANY, N.J.--(BUSINESS WIRE)--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..

拜耳公司将在2024年11月16日至18日于伊利诺伊州芝加哥举行的2024年美国心脏协会（AHA）科学会议的一次特色科学会议上，介绍三项新的预先指定的亚组分析，这些分析来自关键的III期FINEARTS-HF心血管结局试验，研究KERENDIA®（Fineenone）治疗左心室射血分数（LVEF）≥40%的心力衰竭（HF）患者。。

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).1

KERENDIA目前被批准用于降低与2型糖尿病（T2D）相关的成年慢性肾病（CKD）患者的心血管死亡，HF住院，非致命性心肌梗死（MI），持续eGFR下降和终末期肾病的风险

Presentations at AHA 2024 include:

AHA 2024的演讲包括：

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

Fineenone对心力衰竭和射血分数轻度降低或保留的患者使用Win统计分析的分层复合终点的影响：FINEARTS-HF的预先指定分析

Session: Featured Science: Getting Closer to the Summit

会议：特色科学：离峰会越来越近

November 17, 2024, 08:10 am (CST) / 09:10 am (EST)

2024年11月17日上午08:10（CST）/上午09:10（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)..

FINEARTS-HF的主要结果使用赢比方法进行分析，以便根据其临床重要性按以下顺序进行分析：心血管死亡（第1级）；；和紧急HF访问总数（第3级）。。

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

Fineenone在心力衰竭和射血分数轻度降低或保留的患者中的疗效和安全性：FINEARTS-HF试验的预先指定的性别特异性分析

Session: Featured Science: Getting Closer to the Summit

会议：特色科学：离峰会越来越近

November 17, 2024, 08:20 am (CST) / 09:20 am (EST)

2024年11月17日上午08:20（CST）/上午09:20（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.

认识到HF在临床表现，症状和生活质量，预后和治疗反应方面的性别差异，这项预先指定的分析评估了Fineenone对女性和男性LVEF≥40%的HF的疗效和安全性。

Finerenone and Risk of Hyperkalemia in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction

射血分数轻度降低或保留的心力衰竭患者的芬尼酮和高钾血症风险

Session: Featured Science: Getting Closer to the Summit

会议：特色科学：离峰会越来越近

November 17, 2024, 08:30 am (CST) / 09:30 am (EST)

2024年11月17日上午08:30（CST）/上午09:30（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.

这项预先指定的分析调查了高钾血症的频率和预测因素，并根据随机化后的钾水平检查了芬尼酮相对于安慰剂对临床结果的治疗效果。

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.2.

HF是一种复杂的临床综合征，其症状和体征是由心室充盈或血液排出的任何结构性或功能障碍引起的[2]。美国约有670万成年人患有HF，其中约55%的LVEF≥40%[3]。尽管患病率很高，但LVEF≥40%的HF患者的指南指导性药物治疗选择是有限的[4]。该患者群体经常平衡多种合并症，如肥胖，糖尿病，高血压和CKD。

About FINEARTS-HF5

关于FINEARTS-HF5

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.

FINEARTS-HF试验是一项随机，双盲，安慰剂对照，多中心，事件驱动的III期临床试验，研究了KERENDIA®（Fineenone）降低心血管死亡和心力衰竭（HF）事件风险的有效性和安全性。诊断为左心室射血分数（LVEF）≥40%的症状性心力衰竭（纽约心脏协会II-IV级）患者，在过去12个月内通过局部成像测量进行测量，并在随机化前至少30天接受利尿剂治疗。

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..

FINEARTS-HF的主要终点是心血管死亡和总（首次和复发）HF事件的综合，定义为HF住院或紧急HF就诊。大约6000名患者被随机分配接受芬尼酮或安慰剂，每天一次，持续42个月。。

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.6.

FINEARTS-HF发表在《新英格兰医学杂志》上，并于今年早些时候提交给欧洲心脏病学会大会，结果显示该试验达到了其主要终点，达到了16%（比率为0.84；95%置信区间（CI），0.74至0.95；P=0.007），与安慰剂相比，除了患者的处方治疗方案外，心血管死亡和总（首次和复发）心力衰竭（HF）事件（定义为HF住院或紧急HF就诊）的复合主要终点的相对风险降低。

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.

在FINEARTS-HF试验中，与之前使用该化合物的研究相比，没有发现新的安全性信号[6]。治疗组之间的严重不良事件相当，Fineenone组发生率为38.7%（1157/2993），安慰剂组为40.5%（1213/2993）。两组之间因死亡以外的原因停用试验药物的情况相似，芬尼酮组为20.4%（611/2993），安慰剂组为20.6%（616/2993）[6]。与安慰剂组相比，接受芬尼酮治疗的患者肌酐和钾水平升高的频率更高，研究者报告9.7%（289/2993）的芬尼酮治疗患者出现高钾血症，而安慰剂组为4.2%（125/2993）。

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.

在finerenone组的3%（n=86）中观察到血清钾水平>6 mmol/L，而安慰剂组为1.4%（41/2993）。虽然高钾血症在芬尼酮中更常见，但很少导致住院（安慰剂组为0.5%[16/2993]，而安慰剂组为0.2%[6/2993]），并且没有病例导致死亡。

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

包括FINEARTS-HF在内的Fineenone MOONRAKER临床试验项目共有15000多名患者，是迄今为止最大的HF试验项目之一，旨在为广泛的患者和临床环境中的Fineenone建立全面的证据。7

About KERENDIA® (finerenone)1

关于克伦迪亚® （芬兰语）1

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.

KERENDIA是一种非甾体盐皮质激素受体拮抗剂（MRA），于2021年7月获得美国食品和药物管理局（FDA）的批准，以降低与T2D相关的CKD成人持续eGFR下降，终末期肾病，心血管死亡，非致命性心肌梗死和HF住院的风险。

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%..

8月，拜耳宣布finerenone是第一个也是唯一一个在III期试验中达到主要复合心血管终点的非甾体MRA，该试验调查了HF和LVEF≥40%的患者。。

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).9

在与T2D相关的CKD成人中，美国糖尿病协会（ADA）8和欧洲心脏病学会（ESC）建议KERENDIA降低HF住院的风险

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONS:

Concomitant use with strong CYP3A4 inhibitors

与强CYP3A4抑制剂同时使用

Patients with adrenal insufficiency

肾上腺功能不全患者

WARNINGS AND PRECAUTIONS:

警告和注意事项：

Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly.

高钾血症：KERENDIA可引起高钾血症。发生高钾血症的风险随着肾功能的降低而增加，基线钾水平较高或其他高钾血症危险因素的患者发生高钾血症的风险更大。在开始用克伦迪亚治疗之前，测量所有患者的血清钾和eGFR，并相应地给药。

Do not initiate KERENDIA if serum potassium is >5.0 mEq/L. .

如果血清钾>5.0 mEq/L，请勿引发KERENDIA。

Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.

在用克伦迪亚治疗期间定期测量血清钾，并相应调整剂量。对于有高钾血症风险的患者，可能需要更频繁的监测，包括那些服用损害钾排泄或增加血清钾的伴随药物的患者。

MOST COMMON ADVERSE REACTIONS:

最常见的不良反应：

From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% versus 6.9%), hypotension (4.6% versus 3.9%), and hyponatremia (1.3% versus 0.7%).

根据2项安慰剂对照研究的汇总数据，≥1%的KERENDIA患者报告的不良反应比安慰剂更常见的是高钾血症（14%比6.9%），低血压（4.6%比3.9%）和低钠血症（1.3%比0.7%）。

DRUG INTERACTIONS:

药物相互作用：

Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.

强CYP3A4抑制剂：禁止同时使用KERENDIA和强CYP3A4抑制剂。避免同时摄入葡萄柚或葡萄柚汁。

Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate.

中度和弱CYP3A4抑制剂：在KERENDIA或中度或弱CYP3A4抑制剂的药物起始或剂量调整过程中监测血清钾，并酌情调整KERENDIA的剂量。

Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.

强效和中度CYP3A4诱导剂：避免同时使用KERENDIA和强效或中度CYP3A4诱导剂。

USE IN SPECIFIC POPULATIONS:

在特定人群中使用：

Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.

。

Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

肝功能损害：避免在严重肝功能损害（Child-Pugh C）患者中使用KERENDIA，并考虑对中度肝功能损害（Child-Pugh B）进行额外的血清钾监测。

Please click here for full Prescribing Information for KERENDIA.

请点击此处获取凯伦迪亚的完整处方信息。

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

关于拜耳在心血管和肾脏疾病方面的承诺

A leader in the cardiovascular (CV) space, Bayer upholds a long-standing commitment to delivering science for a better life by advancing research and treatment options. Bayer’s cardiorenal franchise, which began with the discovery and development of a number of vital therapies, now includes several products and compounds in various stages of preclinical and clinical development with the potential to impact the way that CV and kidney diseases are treated..

拜耳是心血管领域的领导者，长期以来一直致力于通过推进研究和治疗选择，为更好的生活提供科学。拜耳的心肾特许经营权始于许多重要疗法的发现和开发，现在包括临床前和临床开发各个阶段的几种产品和化合物，可能会影响心血管疾病和肾脏疾病的治疗方式。。

Bayer is investigating potential treatment approaches for areas of high unmet medical need. Currently, Bayer is investigating nine CVR-related projects in different stages of development, including heart failure (HF) and non-diabetic chronic kidney disease (CKD).10

拜耳正在研究针对医疗需求未得到满足的地区的潜在治疗方法。目前，拜耳正在调查9个处于不同发展阶段的CVR相关项目，包括心力衰竭（HF）和非糖尿病慢性肾病（CKD）

Bayer is actively identifying resources and programs aimed at better understanding the real-world management of CKD, expanding screening and early care management for CKD, aligning with and supporting groups and institutions that share the common goals of improving health outcomes, promoting health literacy and education, and promoting research and initiatives that represent the diversity required to address the needs of all patients..

拜耳正在积极确定资源和计划，旨在更好地了解CKD的现实管理，扩大CKD的筛查和早期护理管理，与具有改善健康结果、促进健康素养和教育以及促进代表满足所有患者需求所需多样性的研究和倡议的共同目标的团体和机构保持一致并提供支持。。

About Bayer

拜耳简介

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.

拜耳是一家全球性企业，在医疗保健和营养等生命科学领域拥有核心竞争力。根据其“人人健康，无人饥饿”的使命，该公司的产品和服务旨在通过支持应对全球人口不断增长和老龄化带来的重大挑战，帮助人们和地球繁荣发展。

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 approximately 100,000 people and had sales of 47.6 billion euros.

拜耳致力于推动可持续发展，并对其业务产生积极影响。与此同时，该集团旨在通过创新和增长来提高其盈利能力和创造价值。拜耳品牌代表着全世界的信任、可靠性和质量。2023财年，该集团雇佣了约10万人，销售额476亿欧元。

R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com..

不含特殊项目的研发费用为58亿欧元。欲了解更多信息，请访问www.bayer.com。。

Find more information at https://pharma.bayer.com/

更多信息请访问https://pharma.bayer.com/

Follow us on Facebook: http://www.facebook.com/bayer

Follow us on Facebook: http://www.facebook.com/bayer

Follow us on X: @BayerPharma

在X上关注我们：@BayerPharma

Forward-Looking Statements

前瞻性声明

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.

本版本可能包含基于拜耳管理层当前假设和预测的前瞻性声明。。

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..

。。

1 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf. Accessed October 28, 2024.

1拜耳制药。。U、 美国食品和药物管理局。网址：https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf.2024年10月28日访问。

2 Heidenreich P, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2023. https://pubmed.ncbi.nlm.nih.gov/35379503. Accessed September 19, 2024..

2 Heidenreich P等人，2022 AHA/ACC/HFSA心力衰竭管理指南：美国心脏病学会/美国心脏协会临床实践指南联合委员会的报告。J Am Coll Cardiol。2023https://pubmed.ncbi.nlm.nih.gov/35379503.2024年9月19日访问。。

Accessed October 28, 2024..

2024年10月28日访问。。

3 Bozkurt A, et al. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023; Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. PMID: 37797885; PMCID: PMC10864030.

3 Bozkurt A等人。心力衰竭流行病学和结果统计：美国心力衰竭协会的报告。J卡故障。2023年；十月；29（10）：1412-1451。doi:10.1016/j.cardfail.2023.07.006。Epub 2023年9月26日。PMID:37797885；PMCID:PMC10864030。

4 Desai N, et al. Heart failure with mildly reduced and preserved ejection fraction: A review of disease burden and remaining unmet medical needs within a new treatment landscape. Heart Fail Rev. 2024;29(3):631-662. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11035416/. Accessed October 28, 2024.

4 Desai N等人。射血分数轻度降低和保留的心力衰竭：在新的治疗环境中回顾疾病负担和未满足的医疗需求。心力衰竭修订版2024；29（3）：631-662。https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11035416/.2024年10月28日访问。

5 Trial 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).

5试验评估Fineenone对心力衰竭和左心室射血分数（每次心搏排出的血液比例）参与者的发病率（表明疾病恶化的事件）和死亡率（死亡率）的疗效（对疾病的影响）和安全性大于或等于40%（FINEARTS-HF）。

Clinical trial registration No. NCT04435626. https://clinicaltrials.gov/trial/NCT04435626. Accessed October 28, 2024..

临床试验注册号NCT04435626。https://clinicaltrials.gov/trial/NCT04435626.2024年10月28日访问。。

6 Solomon S, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa2407107. Accessed October 28, 2024.

6 Solomon S等人。射血分数轻度降低或保留的心力衰竭患者。。https://www.nejm.org/doi/full/10.1056/NEJMoa2407107.2024年10月28日访问。

7 Data on file.

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