- Effects of finerenone on cardio-kidney outcomes to be analyzed
in over 19,000 patients1
- Baseline characteristics from FINE-HEART analysis highlight
complex interplay between cardiovascular, kidney, and metabolic
health, with over 92% of patients presenting two or more
conditions1
The study design and baseline characteristics of FINE-HEART, a
new prespecified, exploratory pooled analysis of three Phase III
trials with finerenone1, were presented today as a Late-Breaking
Science Session at Heart Failure 2024, a scientific congress of the
European Society of Cardiology (ESC) in Lisbon.
Finerenone is marketed as Kerendia® and approved for the
treatment of adults with chronic kidney disease (CKD) associated
with type 2 diabetes (T2D) in more than 70 countries worldwide,
including the United States. The data presented here may discuss a
use outside of the approved indication.
FINE-HEART is designed to investigate the effects of finerenone
on cardio-kidney outcomes based on data from over 19,000 patients
with varying combinations of heart failure (HF), CKD and T2D across
three Phase III finerenone studies – FIDELIO-DKD, FIGARO-DKD, and
FINEARTS-HF.1
Over 92% of patients included in the analysis had overlapping
cardio-kidney-metabolic (CKM) conditions—78% had two (HF and CKD,
HF and T2D or CKD and T2D), while 14.7% had all three. 37% of
patients had a history of HF, 81% had a history of T2D, and 89% had
a history of CKD.1
The analysis showed that patients across the three studies were
at high risk for CKD progression with either reduced estimated
glomerular filtration rate (eGFR) [30% with eGFR <45, and 26%
with eGFR 45 to 60 mL/min/1.73m2] and/or albuminuria [31% with “A2”
urine albumin-to-creatinine ratio (UACR) 30-300mg/g, and 49% with
“A3” UACR>300mg/g].1
“The multimorbid patient profile of the FINE-HEART study is
reflective of the patients seen today in real-world clinical
settings, highlighting the critical need for data that investigate
the impact of finerenone on cardio-kidney outcomes,” said Dr.
Robert Perkins MPH, FACP, Vice President, U.S. Medical
Affairs/Cardiovascular-Renal at Bayer. “The 19,000+ individuals
investigated under the umbrella of FINE-HEART represent one of the
most comprehensive studies of individuals living with an
increasingly common and complex set of conditions, and I am
optimistic that the FINE-HEART program may help provide key
insights for clinicians managing ever-more complex patients.”
The prespecified, exploratory pooled analysis FINE-HEART
includes data from the FIDELITY program, which encompasses the
FIDELIO-DKD and FIGARO-DKD trials, having randomized more than
13,000 patients with CKD associated with T2D and albuminuria
(UACR≥30mg/g) on maximally tolerated doses of renin-angiotensin
system inhibitors across 48 countries.2 It also includes data from
the FINEARTS-HF trial, with more than 6,000 patients with HF with
left ventricular ejection fraction (LVEF) ≥40%, elevated
natriuretic peptides, and evidence of structural heart disease
across 37 countries.1
About Kerendia® (finerenone)3
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 heart
failure in adult patients with chronic kidney disease (CKD)
associated with type 2 diabetes (T2D).
Kerendia was studied in the largest CKD clinical trial program,
FIDELIO-DKD (Finerenone in reducing
kiDnEy
faiLure and dIsease prOgression in
Diabetic Kidney Disease) and
FIGARO-DKD (Finerenone in
reducinG cArdiovascular moRtality and mOrbidity
in Diabetic Kidney Disease),
across a broad range of CKD severity in adults with CKD associated
with T2D. In the Kerendia Phase III program for CKD associated with
T2D with over 13,000 people, FIDELIO-DKD and FIGARO-DKD showed
Kerendia reduced the risk of CKD and cardiovascular events.4 Based
on data from the clinical trial program, Kerendia has been
recommended for adults with CKD associated with T2D in several
major treatment guidelines, including those from the American
Diabetes Association® (ADA), the American Association of
Clinical Endocrinology®, and the Kidney Disease: Improving
Global Outcomes® (KDIGO) Foundation, as well as the
ADA/KDIGO Consensus Statement.4
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:
- Concomitant use with strong CYP3A4 inhibitors
- Patients with adrenal insufficiency
WARNINGS AND PRECAUTIONS:
- 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. Do not initiate KERENDIA if
serum potassium is >5.0 mEq/L. 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.
MOST COMMON ADVERSE REACTIONS:
- 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%).
DRUG INTERACTIONS:
- Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA
with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant
intake of grapefruit or grapefruit juice.
- 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.
- Strong and Moderate CYP3A4 Inducers: Avoid concomitant
use of KERENDIA with strong or moderate CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS:
- 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).
Please click here for full Prescribing
Information for KERENDIA.
About Chronic Kidney Disease in Type 2 Diabetes
Patients with chronic kidney disease (CKD) associated with type
2 diabetes (T2D) are three times more likely to die from a
CV-related cause than those with T2D alone.5 CKD is a serious and
progressive condition that is generally underrecognized.6 CKD is a
frequent complication arising from T2D and is also an independent
risk factor of CV disease.7,8,9 Approximately 40% of all patients
with T2D develop CKD. Despite guideline-directed therapies,
patients with CKD associated with T2D remain at high risk of CKD
progression and CV events.6,7,9,10 T2D is the leading cause of
end-stage kidney disease, which requires dialysis or a kidney
transplant to stay alive.10,11,12
About Heart Failure
Heart failure (HF) is a highly prevalent chronic condition,
affecting approximately 6.5 million adults in the U.S.13 HF is
characterized by the progressive decline in the heart’s ability to
pump enough blood to meet the body’s needs for blood and oxygen.13
Symptoms can include shortness of breath, fatigue, chest discomfort
and swelling in the lower body. Risk factors are hypertension,
diabetes mellitus, smoking, a past myocardial infarction and
coronary artery disease.13,14
Patients with diabetes have more than two times the risk of
developing HF than their healthier peers.15 Further, cardiovascular
outcomes, hospitalization and prognosis are worse for patients with
diabetes mellitus than those without. While 10% to 15% of the
general population has diabetes, a study suggests that 44% of
patients hospitalized for HF have diabetes.12
About Bayer’s Commitment in Cardiovascular and Kidney
Diseases
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.
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).4
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.
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 approximately 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.
Find more information at https://pharma.bayer.com/ Follow us on
Facebook: http://www.facebook.com/bayer Follow us on X:
@BayerPharma
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.
_________________________ 1 M. Vaduganathan et al. Design and
baseline characteristics of FINE-HEART: an integrated pooled
analysis of finerenone in >19,000 participants across 3 phase
III trials of HF & CKD. Heart Failure 2024, a scientific
congress of the European Society of Cardiology.; May 11-14.;
Lisbon, Portugal 2 Di Lullo L, Lavalle C, Scatena A, Mariani MV,
Ronco C, Bellasi A. Finerenone: Questions and Answers-The Four
Fundamental Arguments on the New-Born Promising Non-Steroidal
Mineralocorticoid Receptor Antagonist. J Clin Med. 2023 Jun
12;12(12):3992. doi: 10.3390/jcm12123992. PMID: 37373685; PMCID:
PMC10299719. 3 KERENDIA (finerenone) [prescribing information].
Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September
2022. 4 Data on File. 5 Afkarian M, Sachs MC, Kestenbaum B, et al.
Kidney disease and increased mortality risk in type 2 diabetes. J
Am Soc Nephrol. 2013;24(2):302-308. 6 Breyer MD, Susztak K.
Developing treatments for chronic kidney disease in the 21st
century. Semin Nephrol. 2016;36(6):436-447. 7 Anders HJ, Huber TB,
Isermann B, et al. CKD in diabetes: diabetic kidney disease versus
nondiabetic kidney disease. Nat Rev Nephrol. 2018;14:361-377. 8
Thomas MC, Brownlee M, Susztak K, et al. Diabetic kidney disease.
Nat Rev Dis Primers. 2015;1:1-20. 9 Bailey RA, Wang Y, Zhu V, et
al. Chronic kidney disease in US adults with type 2 diabetes: an
updated national estimate of prevalence based on Kidney Disease:
Improving Global Outcomes (KDIGO) staging. BMC Res Notes.
2014;7(1):415. doi:10.1186/1756-0500-7-415. 10 National Diabetes
Statistics Report 2020: Estimates of Diabetes and Its Burden in the
United States. Centers for Disease Control and Prevention. Accessed
July 9, 2021.
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
11 Stages of CKD. American Kidney Fund. Accessed May 11, 2021.
https://www.kidneyfund.org/kidney-disease/chronic-kidney-disease-ckd/stages-of-chronic-kidney-disease.
12 United States Renal Data System. USRDS Annual Data Report.
National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases; 2020. Accessed November 2021.
https://adr.usrds.org/2020/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd.
13 Fine N. Heart failure (HF). MSD Manual Professional Version.
2022 Sept. 14 Dunlay S et al. Risk factors for heart failure: A
population-based case-control study. Am J Med. 2009 Nov; 122(11):
1023–1028. 15 Kenny HC, Abel ED. Heart Failure in Type 2 Diabetes
Mellitus. Circ Res. 2019 Jan 4;124(1):121-141. doi:
10.1161/CIRCRESAHA.118.311371. PMID: 30605420; PMCID:
PMC6447311.
COR-KER-US-0076-1
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Media: Elaine Colón Bayer
Media Relations Elaine.colon@bayer.com +1-732-236-1587