RIDGEFIELD, Conn. and INDIANAPOLIS, Oct. 23, 2020 /PRNewswire/ -- Findings from a new
exploratory sub-analysis of the EMPEROR-Reduced phase III trial
showed that Jardiance® (empagliflozin) reduced
the risk of adverse cardiovascular and kidney events in adults with
heart failure with reduced ejection fraction – with and without
diabetes – regardless of chronic kidney disease status at baseline.
These results were shared today as an oral presentation at the
American Society of Nephrology Kidney Week 2020 and published in
Circulation, Boehringer Ingelheim and Eli Lilly and Company
(NYSE: LLY) announced.
"On their own, heart failure and chronic kidney disease are each
associated with an increased risk of hospitalizations and premature
death from cardiovascular causes. The presence of one condition
often accelerates the onset and progression of the other, further
increasing this risk and leading to poorer prognoses," said Faiez
Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and
Emeritus Professor of Therapeutics at the University of Lorraine,
France. "In EMPEROR-Reduced,
empagliflozin demonstrated a consistent reduction in the risk of
the composite primary endpoint of cardiovascular death and heart
failure hospitalizations, while slowing kidney function decline, in
adults with heart failure with reduced ejection fraction, with and
without chronic kidney disease. This is promising news for the
growing population of adults suffering from both heart failure and
chronic kidney disease."
As previously reported, EMPEROR-Reduced showed Jardiance reduced
the relative risk of the combined endpoint of cardiovascular death
or hospitalization for heart failure by 25% and of first and
recurrent hospitalizations for heart failure by 30%, and slowed the
decline in eGFR, a measure of kidney function, in adults with heart
failure with reduced ejection fraction with and without diabetes.
An additional exploratory analysis showed that Jardiance decreased
the relative risk of a composite kidney endpoint*, including end
stage kidney disease and a profound loss of kidney function, by
50%. In this new analysis of all endpoints, these benefits were
consistently observed in subgroups of patients with and without
chronic kidney disease at baseline, including patients with severe
renal impairment. In all patient cohorts participating in the
EMPEROR-Reduced trial, the safety profile was similar to the
well-established safety profile of Jardiance.
"Over half of people with heart failure have moderate to severe
chronic kidney disease, yet, there remains a need for new treatment
options that address these interconnected conditions," said
Mohamed Eid, M.D., M.P.H, M.H.A,
vice president, Clinical Development & Medical Affairs,
Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim
Pharmaceuticals, Inc. "These findings continue to show the
potential of Jardiance to help improve the lives of adults living
with cardio-renal-metabolic conditions, including heart failure and
chronic kidney disease."
"Heart failure and chronic kidney disease are common,
life-threatening diseases that require improved treatment options.
The EMPOWER clinical development program, including our ongoing
EMPEROR-Preserved and EMPA-KIDNEY trials, explores the potential
role Jardiance may play in improving outcomes for people with these
conditions," said Jeff Emmick, M.D.,
Ph.D., vice president, Product Development, Lilly. "The new
findings from EMPEROR-Reduced will help us achieve our goal of
redefining how people living with these conditions are
treated."
In March 2020, the U.S. Food and
Drug Administration (FDA) granted Fast Track designation to
Jardiance for the treatment of chronic kidney disease,
demonstrating the urgent need for new treatment options for people
living with the condition. This designation covers the ongoing
EMPA-KIDNEY trial, which is investigating the effect of Jardiance
on the progression of kidney disease and occurrence of
cardiovascular death in adults with established chronic kidney
disease, with and without diabetes. Results from EMPA-KIDNEY are
expected in 2022.
The FDA also granted Fast Track designation in June 2019 to Jardiance for the reduction of the
risk of cardiovascular death and hospitalization for heart failure
in people with heart failure. This designation is for the EMPEROR
program, which consists of the EMPEROR-Reduced and
EMPEROR-Preserved trials. EMPEROR-Preserved is exploring the effect
of Jardiance on cardiovascular death or hospitalization for heart
failure in adults with heart failure with preserved ejection
fraction, an area that currently has no approved treatment options.
EMPEROR-Preserved results are expected in 2021. Jardiance is not
indicated for the treatment of heart failure.
The EMPEROR and EMPA-KIDNEY studies are part of the EMPOWER
clinical program, the broadest and most comprehensive of any SGLT2
inhibitor, exploring the impact of Jardiance on the lives of people
across the spectrum of cardio-renal-metabolic conditions.
*Composite exploratory endpoint included chronic
dialysis or renal transplant or sustained reduction of
≥40% in eGFR (CKD-EPI) or a sustained eGFR <15
mL/min/1.73
m2 (for patients with baseline
eGFR ≥30) or sustained eGFR <10
mL/min/1.73
m2 (for patients with baseline
eGFR <30 mL/min/1.73
m2).
About the EMPEROR Heart Failure Studies
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic
heaRt failure) heart failure studies are two phase III, randomized,
double-blind trials investigating once-daily Jardiance compared
with placebo in adults with heart failure with preserved or reduced
ejection fraction*, both with and without diabetes, who are
receiving current standard of care:
- EMPEROR-Reduced [NCT03057977] investigated the safety
and efficacy of Jardiance in patients with heart failure with
reduced ejection fraction (HFrEF).
-
- Primary endpoint: time to first event of adjudicated
cardiovascular death or adjudicated hospitalization for heart
failure
- Number of patients: 3,730
- Completion: 2020
- EMPEROR-Preserved [NCT03057951] investigates the safety
and efficacy of Jardiance in patients with heart failure with
preserved ejection fraction (HFpEF).
-
- Primary endpoint: time to first event of adjudicated
cardiovascular death or adjudicated hospitalization for heart
failure [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 5,990
- Estimated completion: 2021
*Ejection fraction is a measurement of the
percentage of blood the left ventricle pumps out with each
contraction. When the heart relaxes, the ventricle refills with
blood.
- HFrEF occurs when the heart muscle does not contract
effectively, and less blood is pumped out to the body compared with
a normally functioning heart.
- HFpEF occurs when the heart muscle contracts normally
but the ventricle does not fill with enough blood, so less blood
can enter the heart compared with a normally functioning
heart.
About the EMPOWER Program
The Alliance has developed the EMPOWER program to explore the
impact of Jardiance on major clinical cardiovascular and renal
outcomes in a spectrum of cardio-renal-metabolic conditions.
Cardio-renal-metabolic conditions are the leading cause of
mortality worldwide and account for up to 20 million deaths
annually. Through the EMPOWER program, Boehringer Ingelheim and
Lilly are working to advance knowledge of these interconnected
systems and create care which offers integrated, multi-organ
benefits. Comprised of nine clinical trials and two real-world
evidence studies, EMPOWER reinforces the long-term commitment of
the Alliance to improve outcomes for people living with
cardio-renal-metabolic conditions. With 377,000 adults estimated to
have enrolled worldwide upon completion of the studies, it is one
of the broadest and most comprehensive clinical programs for an
SGLT2 inhibitor to date.
The development program encompasses:
- EMPEROR-Reduced, in adults with chronic heart failure with
reduced ejection fraction to reduce the risk of cardiovascular
death or hospitalization due to heart failure
- EMPEROR-Preserved, in adults with chronic heart failure with
preserved ejection fraction to reduce the risk of cardiovascular
death or hospitalization due to heart failure
- EMPULSE, in adults hospitalized for acute heart failure and
stabilized to improve clinical and patient reported outcomes
- EMPACT-MI, to evaluate all-cause mortality and hospitalization
for heart failure in adults with and without type 2 diabetes who
have had an acute myocardial infarction, with the aim to prevent
heart failure and improve outcomes
- EMPA-KIDNEY, in adults with established chronic kidney disease
to reduce the progression of kidney disease and the occurrence of
cardiovascular death
- EMPERIAL-Reduced, in adults with chronic heart failure with
reduced ejection fraction to evaluate functional ability and
patient reported outcomes
- EMPERIAL-Preserved, in adults with chronic heart failure with
preserved ejection fraction to evaluate functional ability and
patient-reported outcomes
- EMPA-REG OUTCOME®, in adults with type 2 diabetes
and established cardiovascular disease to reduce the risk of major
adverse cardiovascular events, including cardiovascular death
- EMPRISE, two non-interventional studies (U.S. and EU-Asia) of
the effectiveness, safety, healthcare utilization and cost of care
of empagliflozin in routine clinical practice in adults with type 2
diabetes across the cardiovascular risk continuum
About Cardio-Renal-Metabolic Conditions
Boehringer Ingelheim and Lilly are driven to transform care for
people with cardio-renal-metabolic conditions, a group of
interconnected disorders that affect more than one billion people
worldwide and are a leading cause of death.
The cardiovascular, renal and metabolic systems are
interconnected, and share many of the same risk factors and
pathological pathways along the disease continuum. Dysfunction in
one system may accelerate the onset of others, resulting in
progression of interconnected diseases such as type 2 diabetes,
cardiovascular disease, heart failure, and kidney disease, which in
turn leads to an increased risk of cardiovascular death.
Conversely, improving the health of one system can lead to positive
effects throughout the others.
Through our research and treatments, our goal is to support
people's health, restoring the harmony between the interconnected
cardio-renal-metabolic systems and reducing their risk of serious
complications. As part of our commitment to those whose health is
jeopardized by cardio-renal-metabolic conditions, we will continue
embracing a multidisciplinary approach towards care and focusing
our resources on filling treatment gaps.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with
diet and exercise to lower blood
sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular
death in adults with type 2 diabetes who have known cardiovascular
disease.
JARDIANCE is not for people with type 1
diabetes or for people with diabetic
ketoacidosis (increased ketones in the blood or
urine).
IMPORTANT SAFETY INFORMATION
Do not take JARDIANCE if you are
allergic to empagliflozin or any of the
ingredients in JARDIANCE.
Do not take JARDIANCE if you have severe
kidney problems or are on dialysis.
JARDIANCE can cause serious side effects, including:
- Dehydration. JARDIANCE can cause some people to have
dehydration (the loss of body water and salt). Dehydration may
cause you to feel dizzy, faint, light-headed, or weak, especially
when you stand up.
You may be at a
higher risk of dehydration if you:
-
- have low blood pressure
- take medicines to lower your blood pressure,
including water pills (diuretics)
- are on a low salt diet
- have kidney problems
- are 65 years of age or older.
- Vaginal yeast infection. Women who
take JARDIANCE may get vaginal yeast infections. Talk to your
doctor if you experience vaginal odor, white or yellowish vaginal
discharge (discharge may be lumpy or look like cottage cheese),
and/or vaginal itching.
- Yeast infection of the penis. Men
who take JARDIANCE may get a yeast infection of the skin around the
penis, especially uncircumcised males and those with chronic
infections. Talk to your doctor if you experience redness, itching
or swelling of the penis, rash of the penis, foul smelling
discharge from the penis, and/or pain in the skin around
penis.
- Ketoacidosis (increased ketones in your blood or
urine). Ketoacidosis is a serious condition and may need
to be treated in the hospital. Ketoacidosis may lead to death.
Ketoacidosis occurs in people with type 1 diabetes and can also
occur in people with type 2 diabetes taking JARDIANCE, even if
blood sugar is less than 250 mg/dL. Ketoacidosis has also
happened in people with diabetes who were sick or who had surgery
during treatment with JARDIANCE. Stop taking JARDIANCE and call
your doctor right away if you get any of the following
symptoms, and if possible, check for ketones in your
urine:
-
-
nausea
- vomiting
- stomach-area (abdominal) pain
- tiredness
- trouble breathing
- Kidney problems. Sudden kidney injury has happened
in people taking JARDIANCE. Talk to your doctor right away if you
reduce the amount you eat or drink, or if you lose liquids; for
example, from vomiting, diarrhea, or being in the sun too
long.
- Serious urinary tract infections. Serious urinary
tract infections can occur in people taking JARDIANCE and may lead
to hospitalization. Tell your doctor if you have symptoms of a
urinary tract infection, such as a burning feeling when passing
urine, a need to urinate often or right away, pain in the lower
part of your stomach or pelvis, or blood in the urine. Sometimes
people also may have a fever, back pain, nausea or vomiting.
- Low blood sugar (hypoglycemia): If you take JARDIANCE with
another medicine that can cause low blood sugar, such as
sulfonylurea or insulin, your risk of low blood sugar is higher.
The dose of your sulfonylurea or insulin may need to be lowered.
Symptoms of low blood sugar may include:
-
- headache
- drowsiness
- weakness
- dizziness
- confusion
- irritability
- hunger
- fast heartbeat
- sweating
- shaking or feeling jittery
- Necrotizing fasciitis. A rare but serious bacterial
infection that causes damage to the tissue under the skin in the
area between and around your anus and genitals (perineum). This
bacterial infection has happened in women and men who take
JARDIANCE, and may lead to hospitalization, multiple surgeries, and
death. Seek medical attention immediately if you have fever or
are feeling very weak, tired or uncomfortable (malaise), and you
develop any of the following symptoms in the area between and
around your anus and genitals: pain or tenderness, swelling, and
redness of skin (erythema).
- Allergic (hypersensitivity) reactions. Symptoms of
serious allergic reactions to JARDIANCE may include:
-
- swelling of your face, lips, throat and other areas of your
skin
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
If you have any of these symptoms, stop taking JARDIANCE and
contact your doctor or go to the nearest emergency room right
away.
- Increased fats in your blood (cholesterol).
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in
females.
These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.
Before taking JARDIANCE,
tell your doctor if you:
- have kidney problems. Your doctor may do blood tests to check
your kidneys before and during your treatment with JARDIANCE
- have liver problems
- have a history of urinary tract infections or problems with
urination
- are going to have surgery. Your doctor may stop your JARDIANCE
before you have surgery. Talk to your doctor if you are having
surgery about when to stop taking JARDIANCE and when to start it
again
- are eating less or there is a change in your diet
- have or have had problems with your pancreas, including
pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the
short term ("binge" drinking)
- have any other medical conditions
- are pregnant or plan to become pregnant. JARDIANCE may harm
your unborn baby. Tell your doctor right away if you become
pregnant during treatment with JARDIANCE
- are breastfeeding or are planning to breastfeed. JARDIANCE may
pass into your breast milk and may harm your baby. Do not
breastfeed while taking JARDIANCE
Tell your doctor about all the
medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal
supplements. Especially tell
your doctor if you take water pills
(diuretics) or medicines that can lower your blood sugar, such
as insulin.
You are
encouraged to report negative side
effects of prescription drugs
to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Prescribing Information and
Medication Guide.
CL-JAR-100057 01.27.2020
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim
and Eli Lilly and Company announced an alliance that centers on
compounds representing several of the largest diabetes treatment
classes. Depending on geographies, the companies either co-promote
or separately promote the respective molecules each contributing to
the alliance. The alliance leverages the strengths of two of the
world's leading pharmaceutical companies to focus on patient needs.
By joining forces, the companies demonstrate their commitment, not
only to the care of people with diabetes, but also to investigating
the potential to address areas of unmet medical need. Clinical
trials have been initiated to evaluate the impact of Jardiance on
people living with heart failure or chronic kidney disease.
About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the
heart of what we do. Our mission is to create breakthrough
therapies that change lives. Since its founding in 1885, Boehringer
Ingelheim is independent and family-owned. We have the freedom to
pursue our long-term vision, looking ahead to identify the health
challenges of the future and targeting those areas of need where we
can do the most good.
As a world-leading, research-driven pharmaceutical company, more
than 51,000 employees create value through innovation daily for our
three business areas: Human Pharma, Animal Health, and
Biopharmaceutical Contract Manufacturing. In 2019, Boehringer
Ingelheim achieved net sales of around $21.3
billion (19 billion euros).
Our significant investment of over $3.9
billion (3.5 billion euros) in
R&D drives innovation, enabling the next generation of
medicines that save lives and improve quality of life.
We realize more scientific opportunities by embracing the power
of partnership and diversity of experts across the life-science
community. By working together, we accelerate the delivery of the
next medical breakthrough that will transform the lives of patients
now, and in generations to come.
Boehringer Ingelheim Pharmaceuticals, Inc., based in
Ridgefield, CT, is the largest
U.S. subsidiary of Boehringer Ingelheim Corporation and is part of
the Boehringer Ingelheim group of companies. In addition,
there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont,
Inc. in Fremont, CA.
Boehringer Ingelheim is committed to improving lives and
strengthening our communities. Please visit
www.boehringer-ingelheim.us/csr to learn more about Corporate
Social Responsibility initiatives.
For more information, please visit www.boehringer-ingelheim.us,
or follow us on Twitter @BoehringerUS.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we
introduced the world's first commercial insulin. Today we are
building upon this heritage by working to meet the diverse needs of
people with diabetes and those who care for them. Through research,
collaboration and quality manufacturing we strive to make life
better for people affected by diabetes and related conditions. We
work to deliver breakthrough outcomes through innovative
solutions—from medicines and technologies to support programs and
more. For the latest updates, visit http://www.lillydiabetes.com/
or follow us on Twitter: @LillyDiabetes and Facebook:
LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with
discovery to make life better for people around the world. We were
founded more than a century ago by a man committed to creating
high-quality medicines that meet real needs, and today we remain
true to that mission in all our work. Across the globe, Lilly
employees work to discover and bring life-changing medicines to
those who need them, improve the understanding and management of
disease, and give back to communities through philanthropy and
volunteerism. To learn more about Lilly, please visit us at
www.lilly.com and newsroom.lilly.com/social-channels.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about Jardiance and reflects Lilly's current belief.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of drug development and
commercialization. Among other things, there can be no guarantee
that future study results will be consistent with the results to
date or that Jardiance will receive additional regulatory
approvals. For a further discussion of these and other risks and
uncertainties that could cause actual results to differ from
Lilly's expectations, please see Lilly's most recent Forms 10-K and
10-Q filed with the U.S. Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
Jardiance® and EMPA-REG OUTCOME® are registered trademarks of
Boehringer Ingelheim.
P-LLY
MPR-US-101417
CONTACT:
Jennifer Forsyth
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Stephan Thalen
Global Business Communications
Lilly Diabetes and Lilly USA
Email: stephan.thalen@lilly.com
Phone: (317) 903-5640
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