- EMPA-KIDNEY, the largest
and broadest dedicated SGLT2 inhibitor trial in chronic kidney
disease, provides new evidence for patients commonly seen in
clinical practice
- Phase III trial also demonstrated a
statistically significant reduction (14%) in hospitalization for
any cause, bringing potential relief for patients and reducing
burden on healthcare systems
OXFORD,
United Kingdom and INGELHEIM, Germany and RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 4, 2022
/PRNewswire/ -- EMPA-KIDNEY phase III clinical trial met its
primary endpoint by demonstrating a significant kidney and
cardiovascular benefit for adults living with chronic kidney
disease (CKD). When treated with
Jardiance® (empagliflozin), the risk of
kidney disease progression or cardiovascular death was
significantly reduced by 28% vs. placebo (HR; 0.72; 95% CI 0.64 to
0.82; P<0.0001). The results were announced today during
the American Society of Nephrology (ASN)'s Kidney Week 2022 by the
Medical Research Council Population Health Research Unit (MRC PHRU)
at the University of Oxford, which
designed, conducted and analyzed EMPA-KIDNEY in a scientific
collaboration with Boehringer Ingelheim and Eli Lilly and Company
(NYSE: LLY). The results were also published simultaneously in
The New England Journal of Medicine.
EMPA-KIDNEY is the first SGLT2 inhibitor CKD trial to
demonstrate a significant reduction in all-cause hospitalizations
(14%) (HR; 0.86; 95% CI 0.78 to 0.95; p=0.0025) vs. placebo, one of
the pre-specified key secondary confirmatory endpoints. CKD
doubles a person's risk for hospitalization and is a leading cause
of death globally. Hospitalizations account for 35%-55% of total
healthcare costs for people with CKD in the U.S.
The overall safety data was generally consistent with previous
findings, confirming the well-established safety profile of
Jardiance.
"We know that there is an urgent need for new therapies proven
to delay CKD progression which can lead to the need for dialysis or
transplantation. Today's results demonstrate that Jardiance may
benefit adults at risk of progression, including those with or
without diabetes, and across a wide range of kidney function," said
William Herrington, associate
professor at MRC PHRU (part of Oxford Population Health), and
honorary consultant nephrologist, and EMPA-KIDNEY co-principal
investigator. "By reducing the risk of kidney disease progression
or cardiovascular death, Jardiance has the potential to positively
impact healthcare systems worldwide."
"The design of the EMPA-KIDNEY trial included a wider range of
patients than ever before," said Professor Richard Haynes, co-principal investigator.
"Previous SGLT2 inhibitor trials focused on certain groups of
people living with CKD, such as those with diabetes or high levels
of protein in their urine. Today's positive trial results across a
broad CKD population reflect an opportunity to improve the
treatment of this disease and prevent people from needing
dialysis."
EMPA-KIDNEY is the largest and broadest dedicated SGLT2
inhibitor trial to date. It included 6,609 participants across a
wide range of underlying causes, many with co-morbidities across
the spectrum of cardiovascular, kidney or metabolic conditions. The
trial assessed both kidney and cardiovascular outcomes in people
across the spectrum of CKD severity.
"The Boehringer Ingelheim and Lilly
Alliance is incredibly proud that EMPA-KIDNEY has provided
another pivotal moment for Jardiance," said Carinne Brouillon, head
of Human Pharma and member of the Board of Managing Directors,
Boehringer Ingelheim. "Today's data adds to the body of evidence
from our clinical program which includes more than 700,000 adults
with cardiovascular, kidney and metabolic conditions. EMPA-KIDNEY
reinforces the potential role of Jardiance in changing the way
these interconnected conditions may be managed."
Reductions in other key secondary endpoints of hospitalization
for heart failure or cardiovascular death or all-cause death were
not statistically significant, however the power to detect this was
limited by the number of events observed. Reduction in the risk of
these endpoints is consistent with the totality of the
evidence from other trials which have shown statistical
significance of these outcomes.
"Today's EMPA-KIDNEY trial results will be welcomed by people
living with CKD and the medical community. We are also encouraged
by the risk reduction for hospitalization after just two years, as
this finding is in line with the significant reductions seen in
prior Jardiance cardiovascular outcomes trials," said Jeff Emmick, M.D., Ph.D., vice president,
Product Development, Lilly. "The Alliance looks forward to
discussing plans for marketing authorization for CKD with
regulators worldwide in due course."
Notes to editors
Kidney disease progression: Defined as end-stage kidney
disease (the initiation of maintenance dialysis or receipt of a
kidney transplant), a sustained decline in estimated glomerular
filtration rate (eGFR) to below 10 mL/min/1.73 m2, kidney death or a sustained
decline of at least 40% in eGFR from randomization).
End stage kidney disease: Includes initiation of maintenance
dialysis or receipt of a kidney transplant
About EMPA-KIDNEY: The study of heart and kidney protection
with Jardiance
EMPA-KIDNEY (NCT03594110) is a multinational, randomized,
double-blind, placebo-controlled clinical trial, designed to
evaluate the effect of Jardiance on kidney disease progression and
cardiovascular mortality risk. The primary outcome is defined as
time to a first event of either cardiovascular death or kidney
disease progression, defined as end-stage kidney disease (the need
for kidney replacement therapy such as dialysis or kidney
transplantation), a sustained decline in eGFR to <10
mL/min/1.73 m2, kidney
death, or a sustained decline of ≥40 percent in eGFR from
randomization. Key secondary outcomes include cardiovascular death
or hospitalization for heart failure, all-cause hospitalization and
all-cause mortality. EMPA-KIDNEY includes 6,609 adults randomized
from eight countries with established CKD both with and without
diabetes, as well as with and without albuminuria, receiving either
Jardiance 10 mg or placebo, on top of current standard of
care.
About the Medical Research Council Population Health Research
Unit (MRC PHRU) at the University of
Oxford
The MRC PHRU at the University of Oxford, part of Oxford Population
Health, improves the treatment and prevention of chronic diseases,
particularly cardiovascular disease and metabolic disease (such as
diabetes mellitus and CKD), which collectively account for a large
proportion of premature adult deaths and the burden of disability
worldwide. MRC PHRU is led by EMPA-KIDNEY Steering Committee
co-chair Professor Colin Baigent.
MRC PHRU coordinates innovative clinical trials and meta-analyses
that have a major impact on health. Other major studies include the
ground-breaking Randomised Evaluation of COVID-19 Therapy
(RECOVERY) trial which is co-led by EMPA-KIDNEY Steering Committee
co-chair, Professor Sir Martin
Landray. MRC PHRU's worldwide approach, involving the study
of large numbers of people, provides reliable information about the
causes of disease and the effects of treatments, and has had a
major impact on global health.
About the EMPOWER program
The Boehringer Ingelheim and
Lilly Alliance has developed the
EMPOWER program to explore the impact of Jardiance on major
clinical cardiovascular and kidney outcomes in a spectrum of
cardio-kidney-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-kidney-metabolic conditions. With more than
700,000 adults enrolled worldwide in clinical trials, it is the
broadest and most comprehensive clinical program for an SGLT2
inhibitor to date.
What is JARDIANCE?
JARDIANCE is a prescription medicine used to:
- reduce the risk of cardiovascular death and hospitalization for
heart failure in adults with heart failure, when the heart cannot
pump enough blood to the rest of your body
- reduce the risk of cardiovascular death in adults with type 2
diabetes who also have known cardiovascular disease
- lower blood sugar along with diet and exercise in adults with
type 2 diabetes
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 a 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
JARDIANCE before you have surgery. Talk to your healthcare provider
about when to stop taking JARDIANCE if you are having surgery 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.
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-100131 10.17.2022
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.
About Boehringer Ingelheim
Boehringer Ingelheim is
working on breakthrough therapies that improve the lives of humans
and animals. As a leading research-driven biopharmaceutical
company, the company creates value through innovation in areas of
high unmet medical need. Founded in 1885 and family-owned ever
since, Boehringer Ingelheim takes a long-term perspective. Around
52,000 employees serve more than 130 markets in the three business
areas, Human Pharma, Animal Health, and Biopharmaceutical Contract
Manufacturing. Learn more at www.boehringer-ingelheim.us
About Eli Lilly and Company
Lilly unites caring with
discovery to create medicines that make life better for people
around the world. We've been pioneering life-changing discoveries
for nearly 150 years, and today our medicines help more than 47
million people across the globe. Harnessing the power of
biotechnology, chemistry and genetic medicine, our scientists are
urgently advancing new discoveries to solve some of the world's
most significant health challenges, redefining diabetes care,
treating obesity and curtailing its most devastating long-term
effects, advancing the fight against Alzheimer's disease, providing
solutions to some of the most debilitating immune system disorders,
and transforming the most difficult-to-treat cancers into
manageable diseases. With each step toward a healthier world, we're
motivated by one thing: making life better for millions more
people. That includes delivering innovative clinical trials that
reflect the diversity of our world and working to ensure our
medicines are accessible and affordable. To learn more about Lilly,
please visit us
at lilly.com and lilly.com/newsroom or follow
us on Facebook, Instagram, Twitter and LinkedIn.
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate
Headquarters in Ingelheim, Germany
and is intended to provide information about our global business.
Please be aware that information relating to the approval status
and labels of approved products may vary from country to country,
and a country-specific press release on this topic may have been
issued in the countries where Boehringer Ingelheim and Eli Lilly
and Company do business.
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 and hospitalization for heart failure
in adults with heart failure, and as a potential treatment for
adults with cardio-kidney-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-Reduced®,
EMPEROR-Preserved®, EMPA-REG
OUTCOME® and EMPACT-MI® are registered
trademarks of Boehringer Ingelheim.
P-LLY
MPR-US-102395
CONTACTS:
Sheryl van der Hilst
Boehringer Ingelheim
Email: sheryl.van_der_hilst@boehringer-ingelheim.com
Phone: (203) 791-5906
Stephan Thalen
Eli Lilly and Company
Email: stephan.thalen@lilly.com
Phone: +1 (317) 903-5640
Lulu Phillips
Communications Officer, Oxford Population Health
Email: louise.phillips@ndph.ox.ac.uk
Phone: +44 (0)1865 617824
or
Anne Whitehouse
Director of Communications and Public Engagement, Oxford Population
Health
Email: anne.whitehouse@ndph.ox.ac.uk
Phone: +44 (0) 1865 289474
Mobile: +44 (0) 7812 165934
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