New post-hoc analysis of EMPA-REG OUTCOME® examined cost-effectiveness of empagliflozin versus standard of care in a subgroup of people with type 2 diabetes and diabetic kidney disease

INGELHEIM, Germany & INDIANAPOLIS, Ind.–(BUSINESS WIRE)–Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today
announced results from a new cost-effectiveness analysis of the EMPA-REG
OUTCOME® trial in a subgroup of 2,250 people with type 2
diabetes and established cardiovascular disease who also have diabetic
kidney disease.1 Results suggest that treatment with
empagliflozin, in addition to standard of care, leads to fewer
cardiovascular and renal events, and has the potential to be a
cost-effective treatment option for people with type 2 diabetes and
diabetic kidney disease from the perspective of payers in the US.1 The
results were presented at the ISN World Congress of Nephrology 2019 on
13 April in Melbourne, Australia.

Currently, there are more than 425 million people living with diabetes
worldwide, 30-40 percent of whom are at risk of developing diabetic
kidney disease.2,3 Furthermore, one third of people with
diabetic kidney disease are at risk of progressing to end-stage kidney
disease.3 Type 2 diabetes and diabetic kidney disease
independently increase the risk of developing cardiovascular disease,
with up to 1.2 million deaths from cardiovascular disease attributed to
impaired kidney function.4 This progression of diabetic
kidney disease among people with type 2 diabetes imposes substantial
medical care costs.4 Typically, high-income countries spend
more than 2-3 percent of their annual healthcare budget on the treatment
of end-stage kidney disease.4

Diabetic kidney disease occurs in up to 40 percent of people living
with type 2 diabetes, many of whom are at substantial risk of
experiencing kidney failure. This places a huge burden, not only on the
patient’s life and the lives of their loved ones, but also on healthcare
systems,” said Waheed Jamal, MD, Corporate Vice President and Head of
CardioMetabolic Medicine, Boehringer Ingelheim. “We are encouraged by
this latest analysis of the EMPA-REG OUTCOME® trial, which
suggests that empagliflozin has the potential to be a cost-effective
treatment option for people with type 2 diabetes and diabetic kidney

Empagliflozin is not indicated for the prevention of kidney disease.

Cost effectiveness analysis is a conventional method of evaluating the
economic impact of a treatment. The results were garnered using a
simulation economic model to predict clinical events and estimated costs
for the EMPA-REG OUTCOME® trial subgroup of patients with
type 2 diabetes and established cardiovascular disease who also have
diabetic kidney disease receiving empagliflozin with standard of care
versus standard of care alone.1 The modeling and simulation
of cost effectiveness was performed using the cost per episode of
certain diabetes-related clinical events and health utilities in the US
associated with these events. Patients receiving empagliflozin were
predicted to experience fewer of these clinical events, including
progression of albuminuria (presence of the protein albumin in the
urine), composite renal outcomes, hospitalisation for heart failure and
cardiovascular deaths. Additionally, patients taking empagliflozin with
standard of care were projected to survive 1.37 years longer compared to
standard of care alone. This sensitivity analyses showed that, from a US
perspective, empagliflozin could be a cost effective option for 99
percent of people with type 2 diabetes and cardiovascular disease at a
threshold of $100,000/quality-adjusted life years (QALYs).1*†

Boehringer Ingelheim and Eli Lilly and Company are committed to
addressing the high, unmet clinical need for additional therapies to
reduce the risk of kidney disease progression and cardiovascular disease
in people with kidney disease, irrespective of whether or not they have
diabetes,” said Sherry Martin, M.D., Vice President, Medical Affairs,
Lilly Diabetes. “We are looking forward to validating the results
presented today with the patient outcomes in EMPA-KIDNEY, which
investigates whether empagliflozin could help improve the lives of
people living with kidney disease.”

In the landmark EMPA-REG OUTCOME® trial, empagliflozin showed
promising results related to the reduction in the relative risk of new
onset or worsening kidney disease.5 Based on these insights,
Boehringer Ingelheim and Lilly have initiated an academic collaboration
with the Medical Research Council Population Health Research Unit at the
University of Oxford (MRC PHRU) to conduct EMPA-KIDNEY.6 The
study investigates the effects of empagliflozin on the progression of
kidney disease and the occurrence of cardiovascular death in people with
established chronic kidney disease with and without diabetes.
Recruitment for the trial started in 2019 with the first results
expected in 2022.6

About diabetic kidney disease
Diabetic kidney disease is a
progressive decline of kidney function over time that occurs in 30-40
percent of all people with diabetes.3 One third of people
with diabetic kidney disease may develop end-stage kidney disease, also
known as kidney failure.3 Once end-stage kidney disease is
reached, affected individuals have to undergo kidney replacement
treatments, such as chronic dialysis or kidney transplantation.7
Since there is currently no approved treatment available to specifically
reduce kidney disease progression and cardiovascular death, the
overarching unmet medical need for new treatment options for people with
kidney disease is evident.

About EMPA-KIDNEY: The study of heart and kidney protection with
EMPA-KIDNEY is a multinational
randomised, double-blind, placebo-controlled clinical trial. It is
designed to evaluate the effect of empagliflozin on clinically relevant
outcomes: kidney disease progression and cardiovascular mortality risk.
The primary outcome is defined as time to a first event of either a
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
<10mL/min/1.73m2, renal death or a sustained decline of
≥40 percent in eGFR from randomisation. EMPA-KIDNEY includes people with
established chronic kidney disease both with and without diabetes
receiving current standard of care.

The study is conducted in selected countries representing a global
footprint and aims to randomise approximately 5,000 participants to
receive either empagliflozin 10mg once daily or placebo, on top of
standard of care.

About EMPA-REG OUTCOME® (NCT01131676)5
OUTCOME® was a long-term, multicenter, randomised,
double-blind, placebo-controlled trial of more than 7,000 patients from
42 countries with type 2 diabetes and established cardiovascular disease.

The study assessed the effect of empagliflozin (10mg or 25mg once daily)
added to standard of care compared with placebo added to standard of
care. Standard of care was comprised of glucose-lowering agents and
cardiovascular drugs (including for blood pressure and cholesterol). The
primary endpoint was defined as time to first occurrence of
cardiovascular death, non-fatal heart attack or non-fatal stroke.

The overall safety profile of empagliflozin was consistent with that of
previous trials.

About Empagliflozin
Empagliflozin (marketed as Jardiance®)
is an oral, once daily, highly selective sodium glucose cotransporter 2
(SGLT2) inhibitor and the first type 2 diabetes medicine to include
cardiovascular death risk reduction data in the label in several

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes
and high blood sugar levels leads to excretion of excess sugar in the
urine. In addition, initiation of empagliflozin increases excretion of
salt from the body and reduces the fluid load of the body’s blood vessel
system (i.e. intravascular volume). Empagliflozin induces changes to the
sugar, salt and water metabolism in the body that may contribute to the
reductions in cardiovascular death observed in the EMPA-REG OUTCOME®

Please click on the following link for ‘Notes to Editors’ and

* Quality-adjusted life years (QALYs) reflect a patient’s health by
weighting life years lived with a health-related utility score, which
puts a value on the reduction in a patient’s quality of life

† $100,000/QALY is the threshold for cost-effectiveness analysis in the
US. This figure is based on an estimate of the cost-effectiveness of
dialysis for chronic kidney disease

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