New post-hoc analysis shows consistent cardiorenal risk reductions of empagliflozin in a sub-group of adults with type 2 diabetes and chronic kidney disease without overt proteinuria

• Findings from a post-hoc analysis of the EMPA-REG OUTCOME^®
  trial in adults with type 2 diabetes and chronic kidney disease
  without overt proteinuria were presented at the 79^th
  American Diabetes Association Scientific Sessions^®

INGELHEIM, Germany & INDIANAPOLIS, US–(BUSINESS WIRE)–Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today
announced results of a new post-hoc analysis of data from the EMPA-REG
OUTCOME^® trial. These results indicated that the effect of
empagliflozin on reducing cardiovascular and renal risk was consistent
between a sub-group of adults with type 2 diabetes and established
cardiovascular disease, who also have a form of chronic kidney disease
without overt proteinuria (high levels of protein in the urine), and all
others in the trial.¹ The results were shared as an oral
presentation at the 79^th American Diabetes Association (ADA)
Scientific Sessions^® on 10 June in San Francisco, California,
US.

“We are pleased to share new research data from the landmark EMPA-REG
OUTCOME^® trial, examining the effects of empagliflozin in
adults with type 2 diabetes who have an increasingly common, yet
infrequently studied, form of chronic kidney disease,” said Waheed
Jamal, MD, Corporate Vice President and Head of CardioMetabolic
Medicine, Boehringer Ingelheim. “The results support the need for
additional studies aimed at addressing important unmet medical needs for
people with various forms of kidney disease. To that end, we have
initiated a large outcomes trial, EMPA-KIDNEY, to investigate the
effects of empagliflozin on cardiovascular death and the progression of
kidney disease in a broad population of adults with chronic kidney
disease.”

Globally, more than 500 million people are affected by chronic kidney
disease, up to 40 percent of whom have diabetes.^2,3,4 Chronic
kidney disease is typically accompanied by the presence of varying
amounts of protein in the urine, known as proteinuria.⁵ The
majority of people with chronic kidney disease, however, have normal to
moderately-increased urinary protein levels, rather than overt
proteinuria.⁵ Kidney disease without overt proteinuria is
becoming more common yet is rarely studied in clinical trials, despite
the known increased risk for adverse outcomes.⁵

In this new post-hoc analysis, the effect of empagliflozin on reducing
the risk of cardiovascular and kidney outcomes was consistent between
people in the EMPA-REG OUTCOME^® trial who had chronic kidney
disease without overt proteinuria and all others in the trial.¹
Outcomes examined included cardiovascular death, hospitalisation for
heart failure, new or worsening kidney disease, and the combination of
cardiovascular death or hospitalisation for heart failure, as well as
safety outcomes of interest.¹

Furthermore, results from a separate post-hoc analysis recently
presented at the ISN World Congress of Nephrology 2019, indicated that
the effect of empagliflozin on the cardiorenal outcome*, was consistent
between people in the EMPA-REG OUTCOME^® trial who had
proteinuric kidney disease and all others in the trial. Together, these
post-hoc analyses suggest that the effect of empagliflozin on
cardiorenal outcomes is consistent regardless of whether patients have
proteinuric kidney disease or not.

“These new findings are just one part of a broad and comprehensive
clinical development programme that explores how empagliflozin can
improve patient health outcomes and fill therapeutic gaps to serve as a
broad cardiometabolic treatment option,” said Sherry Martin, MD, Vice
President, Medical Affairs, Lilly. “We look forward to gathering
additional information through results from EMPA-KIDNEY, which will
examine the potential for empagliflozin to improve outcomes for people
with chronic kidney disease, including those with and without
proteinuria.”

EMPA-KIDNEY will enrol approximately 5,000 adults with chronic kidney
disease both with and without diabetes as well as with and without
proteinuria worldwide.⁶

*Defined as end-stage kidney disease (initiation of maintenance renal
replacement therapy or sustained eGFR <15 ml/min/1.73m²),
sustained doubling or creatinine, or renal/cardiovascular death.

About EMPA-KIDNEY: The study of heart and kidney protection with
empagliflozin⁶
EMPA-KIDNEY (NCT03594110) is a
multinational randomised, double-blind, placebo-controlled clinical
trial, 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 either empagliflozin 10 mg or placebo, on top of
current standard of care.

EMPA-KIDNEY is an academic collaboration, independently conducted,
analysed and reported by the Medical Research Council Population Health
Research Unit at the University of Oxford (MRC PHRU), which is based in
the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU).
Boehringer Ingelheim and Lilly are providing the funding for the study
as part of their commitment to advancing treatments and pioneering
research to address the public health challenges of cardiovascular,
metabolic and kidney diseases beyond type 2 diabetes.

About Chronic Kidney Disease
Chronic kidney disease is
defined as a progressive decline of kidney function over time. About two
thirds of chronic kidney disease cases are attributable to metabolic
conditions such as diabetes (known as diabetic kidney disease), obesity
and hypertension.^7,8,9

Notably, chronic kidney disease is associated with increased morbidity
and mortality. The majority of deaths among people with chronic kidney
disease occur as a result of cardiovascular complications, often before
reaching end-stage kidney disease.^10,11,12 Once end-stage
kidney disease is reached, affected individuals have to undergo kidney
replacement treatments, such as chronic dialysis or kidney
transplantation.¹³ Chronic kidney disease is highly prevalent
in various parts of the world, affecting more than 10 percent of the
population.¹⁴ 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 in people with chronic kidney disease is evident.

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
countries.^15,16,17

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^®
trial.

Please click on the following link for ‘Notes to Editors’ and
‘References’: http://www.boehringer-ingelheim.com/press-release/type-2-diabetes-cardiorenal-post-hoc-analysis

Contacts

Dr Petra Kienle
Product Communication Manager
Boehringer
Ingelheim
Email: [email protected]
Phone:
+49 (6132) 77 143877

Stephan Thalen
Global Business Communications
Lilly
Diabetes
Email: [email protected]
Phone:
+1 (317) 276 8304