RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 5,
2021 /PRNewswire/ -- Jardiance®
(empagliflozin) reduced the risk for the composite primary endpoint
of cardiovascular death or hospitalization for heart failure and
slowed kidney function decline in adults with heart failure with
left ventricular ejection fraction (LVEF) over 40% regardless of
chronic kidney disease status at baseline, according to findings
from a new prespecified sub-analysis of the
EMPEROR-Preserved® phase III trial. In
EMPEROR-Preserved, two thirds of enrolled adults had heart failure
with preserved ejection fraction (HFpEF; LVEF of at least 50%) and
one third had mildly reduced LVEF (greater than 40% but less than
50%). The results were presented today at the American Society of
Nephrology Kidney Week 2021, Boehringer Ingelheim and Eli Lilly and
Company (NYSE: LLY) announced.
"Heart failure and chronic kidney disease are intimately linked
— the risk of death in people with heart failure increases with
kidney function decline," said Faiez Zannad, M.D., Ph.D.,
EMPEROR Program clinical investigator and Emeritus Professor of
Therapeutics and Cardiology at the University of Lorraine,
France. "The consistent benefits
shown for the reduction of serious heart failure events and the
slowing of kidney function decline regardless of chronic kidney
disease status are welcome results for both patients and
physicians. The findings underscore the potential value of
empagliflozin across a wide range of kidney function in this heart
failure population that includes people with preserved ejection
fraction."
Nearly half of adults with heart failure also have chronic
kidney disease. Together, these conditions are associated with high
mortality rates and risk for hospital admission. More than 6
million people in the U.S. have heart failure, and approximately
half of them have HFpEF. No currently approved treatments have been
clinically proven to significantly improve outcomes across the full
spectrum of heart failure.
"Heart failure, especially with preserved ejection fraction, is
a complex, difficult-to-treat condition, and the prognosis only
worsens with the combined burden of chronic kidney disease," 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. "The encouraging results from this
sub-analysis further demonstrate the potential for Jardiance to
offer a treatment option for adults with cardio-renal-metabolic
conditions."
As previously reported, EMPEROR-Preserved showed that Jardiance
significantly reduced the risk for the composite primary endpoint
of cardiovascular death or hospitalization for heart failure in
adults with heart failure with LVEF over 40% compared with placebo.
Jardiance also significantly reduced the risk of first and
recurrent hospitalizations for heart failure and slowed kidney
function decline.
Over half (53.5%) of adults in EMPEROR-Preserved had chronic
kidney disease (defined as eGFR below 60 mL/min/1.73 m2 or UACR above 300
mg/g) at trial entry, and 9.7% had severe kidney impairment
(eGFR below 30 mL/min/1.73
m2). The new prespecified sub-analysis of
EMPEROR-Preserved demonstrated that the benefits seen in the
overall population were consistent in adults with and without
chronic kidney disease. Jardiance consistently improved
cardiovascular outcomes and slowed kidney function decline across
the full range of kidney function down to an eGFR of 20
mL/min/1.73 m2. Jardiance
was well tolerated regardless of the level of baseline kidney
function.
"This data marks an important milestone for the growing number
of people living with both heart failure and chronic kidney
disease, many of whom are in need of additional treatment options
for these interconnected, complex conditions," said Jeff Emmick, M.D., Ph.D., vice president,
Product Development, Lilly. "We look forward to continuing research
with the goal of addressing the unmet needs of those with kidney
impairment, including through our EMPA-KIDNEY phase III trial of
Jardiance, from which we eagerly await a readout next year."
The U.S. Food and Drug Administration (FDA) previously granted
Fast Track designation for the development of Jardiance to reduce
the risk of cardiovascular death and hospitalization for heart
failure in adults with chronic heart failure (New York
Heart Association [NYHA] Class II-IV). The Fast Track
designation is for the EMPEROR program, which consists of the
EMPEROR-Reduced® and EMPEROR-Preserved trials. The
EMPEROR-Reduced results formed the basis of the recent FDA approval
for heart failure with reduced ejection fraction. Based on results
from EMPEROR-Preserved, the FDA granted Breakthrough Therapy
designation for Jardiance as an investigational treatment for
adults with HFpEF. Jardiance is not indicated for the treatment of
HFpEF.
In March 2020, the FDA also
granted Fast Track designation to Jardiance for the treatment of
chronic kidney disease. 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. Jardiance is not indicated for
the treatment of chronic kidney disease.
About EMPEROR-Preserved
EMPEROR-Preserved (NCT03057951) was a phase III international,
randomized, double–blind trial that enrolled 5,988 adults with and
without type 2 diabetes. All participants had heart failure (New
York Heart Association [NYHA] functional class II, III or IV)
and LVEF over 40%; 4,005 (67%) had HFpEF (LVEF of at least 50%),
and 1,983 (33%) had mildly reduced LVEF (greater than 40% but less
than 50%).
Participants were randomized to once-daily Jardiance 10 mg
(n=2997) or placebo (n=2991), on top of treatment with
guideline-directed heart failure therapy. Median follow-up time was
26.2 months. The composite primary endpoint was defined as time to
first event of cardiovascular death or hospitalization for heart
failure.
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 more than
400,000 adults enrolled worldwide in clinical trials, 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
Prioritizing Cardio-Renal-Metabolic Care
Through research and educational initiatives, Boehringer Ingelheim
and Lilly are driven to redefine 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 (kidney) and metabolic systems are
closely intertwined and share many of the same
disease-related pathways. Dysfunction in one system may
accelerate the onset of dysfunction in others, resulting in the
progression of comorbid diseases such as type 2 diabetes,
heart failure and chronic kidney disease. Conversely, improving the
health of one system can lead to positive effects
across the others and can help reduce the risk for
further complications.
Understanding their interconnected nature, we are working to
advance treatments for people with cardio-renal-metabolic
conditions. It is only through a holistic approach to care
that we can truly transform outcomes and restore the harmony
between these critical systems.
What is JARDIANCE?
(www.jardiance.com)
JARDIANCE is a prescription medicine used to:
- lower blood sugar along with diet and exercise in adults with
type 2 diabetes
- reduce the risk of cardiovascular death in adults with type 2
diabetes who also have known cardiovascular disease
- reduce the risk of cardiovascular death and hospitalization for
heart failure (when the heart is weak and cannot pump enough blood
to the rest of your body) in adults with heart failure
JARDIANCE is not for people with type 1
diabetes. It may increase their risk of diabetic
ketoacidosis (increased ketones in the blood or
urine).
JARDIANCE is not for use to lower blood sugar in adults with
type 2 diabetes who have severe kidney problems, because it may not
work.
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 are
on dialysis.
JARDIANCE can cause serious side effects, including:
- Ketoacidosis (increased ketones in your blood or
urine). Ketoacidosis is a serious condition which needs 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 healthcare provider right away or go to the nearest hospital
emergency room 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
- Dehydration. JARDIANCE can cause some people
to become dehydrated (the
loss of body water and salt).
Dehydration may cause you to feel dizzy,
faint, light-headed,
or weak, especially when you stand up. Sudden
worsening of kidney function has happened in people who are taking
JARDIANCE.
You may be at a
higher risk of dehydration if you:
-
- 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
Talk to your healthcare provider about what you can do to
prevent dehydration, including how much fluid you should drink on a
daily basis, and if you reduce the amount of food or liquid you
drink, if you are sick or cannot eat, or start to lose liquids from
your body 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 healthcare provider 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).
-
Vaginal yeast infection. Talk to
your healthcare provider if you have 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. Swelling of an uncircumcised penis may develop that
makes it difficult to pull back the skin around the tip of the
penis. Talk to your healthcare provider if you have
redness, itching or swelling of
the penis, rash of the penis, foul smelling discharge
from the penis, and/or pain in the
skin around the penis.
Talk to your healthcare provider about what to do if you get
symptoms of a yeast infection of the vagina or penis. Your
healthcare provider may suggest you use an over-the-counter
antifungal medicine. Talk to your healthcare provider right away if
you use an over-the-counter antifungal medication and your symptoms
do not go away.
- 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 healthcare
provider or go to the
nearest emergency room right away.
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 healthcare
provider or pharmacist.
Before taking JARDIANCE, tell your healthcare
provider about all of your medical conditions, including
if you:
- have kidney problems
- have liver problems
- have a history of infection of the vagina or penis
- have a history of
urinary tract infections or problems with
urination
- are going to have surgery. Your healthcare provider may stop
your JARDIANCE before you have surgery. Talk to your healthcare
provider 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 type 1 diabetes. JARDIANCE should not be used to treat
people with type 1 diabetes
- are pregnant or plan to become pregnant.
JARDIANCE may harm your unborn baby. Tell your healthcare
provider 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 healthcare
provider about all the medicines you take,
including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Especially tell
your healthcare provider 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-100093 08.18.2021
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, with
around 52,000 employees, we create value through innovation daily
for our three business areas: Human Pharma, Animal Health, and
Biopharmaceutical Contract Manufacturing. In 2020, Boehringer
Ingelheim achieved net sales of around 22.33
billion USD (19.57 billion
EUR). Our significant investment of over 4.2 billion USD (3.7
billion EUR) in 2020 (18.9% of net sales) 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 health care leader that unites caring with
discovery to create medicines that 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 lilly.com and lilly.com/newsroom.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about Jardiance as a treatment for adults with type 2
diabetes, to reduce the risk of cardiovascular death in adults with
type 2 diabetes and known cardiovascular disease, and to reduce the
risk of cardiovascular death plus hospitalization for heart failure
in adults with heart failure with reduced ejection fraction, and as
a potential treatment for adults with cardio-renal-metabolic
conditions and reflects Lilly's current beliefs and expectations.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of drug research,
development and commercialization. Among other things, there can be
no guarantee that planned or ongoing studies will be completed as
planned, 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®, EMPEROR-Preserved®,
EMPEROR-Reduced® and EMPA-REG OUTCOME®
are registered trademarks of Boehringer Ingelheim.
P-LLY
MPR-US-101872
CONTACTS:
Jennifer
Forsyth
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Stephan Thalen
Global
Business Communications
Eli Lilly and Company
Email: stephan.thalen@lilly.com
Phone: (317) 276-8304
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