Heavy!

Recently, Oxford University Medical Research Council (MRC) Population Health Research, Boehringer Ingelheim and Eli Lilly (NYSE: LLY) announced that the EMPA-KIDNEY clinical trial will be Terminated early, this clinical trial evaluated empagliflozin in adults with chronic kidney disease (CKD)

As the largest clinical trial to date of an SGLT2 inhibitor in CKD, EMPA-KIDNEY is evaluating the efficacy and safety of empagliflozin in adult patients with CKD in a population that is common in clinical practice but has previously been tested with an SGLT2 inhibitor In adults with underrepresented CKD, this clinical trial aims to address a critical unmet clinical need

• mild to severe reduction in eGFR (a measure of kidney function);

• Normal and elevated levels of albumin (a protein present in urine);

• with and without diabetes;

• CKD due to a wide range of potential causes

EMPA-KIDNEY is a large, double-blind, randomized, placebo-controlled, academic-led clinical trial of more than 6,600 adults with CKD

"Chronic kidney disease kills 5 to 10 million people worldwide each year, and the lives of many patients are severely impacted by frequent dialysis treatments," said Associate Professor William Herrington, University of Oxford Population Health Clinical Scientist, Honorary Consultant in Nephrology, and EMPA-KIDNEY Co-Principal Investigator

"We are delighted that the clinical trial showed that empagliflozin benefited patients enrolled in the EMPA-KIDNEY study," said co-principal investigator Professor Richard Haynes

Kidney disease is a global public health problem, affecting nearly 850 million people, or more than 1 in 10 adults

"Committed to helping the millions of people with chronic kidney disease, the early termination of the EMPA-KIDNEY trial brings us one step closer to achieving this goal faster," said Waheed Jamal, Corporate Vice President and Head of Cardiometabolic Medicine, Boehringer Ingelheim said the MD

Full results from the EMPA-KIDNEY clinical trial will be presented at an upcoming medical congress

"EMPA-KIDNEY enrolled a broad range of adults with kidney disease who were excluded or underrepresented in previous trials focused on SGLT2 inhibitors to slow the progression of kidney disease," said Eli Lilly, Vice President of Product Development said Jeff Emmick, MD

EMPA-KIDNEY follows the landmark EMPA-REG OUTCOME ^® and EMPEROR clinical trials, all of which demonstrated the cardiorenal benefits of empagliflozin

The EMPA-KIDNEY trial is part of the EMPOWER clinical program, the most extensive and comprehensive clinical research program of any SGLT2 inhibitor to date, to explore the impact of empagliflozin on the lives of patients with various cardio-renal-metabolic diseases
.

*Defined as end-stage renal disease (starting maintenance dialysis or receiving kidney transplantation), persistent decline in eGFR to less than 10 mL/min/1.
73 m ² , renal death after randomization, or persistent decline in eGFR of at least 40%
.

†Prespecified secondary exploratory endpoint: 39% relative risk reduction for renal disease events or worsening
.
It was defined as progression to macroalbuminuria, doubling of serum creatinine (with eGFR [MDRD] ≤45 mL/min/1.
73 m ² ), initiation of renal replacement therapy, or death from renal disease
.

eGFR assesses glomerular filtration rate; MDRD: dietary changes in renal disease
.

About Chronic Kidney Disease

About one-third of chronic kidney disease is caused by metabolic diseases such as diabetes (ie, diabetic nephropathy), hypertension and obesity
.
[12 13] Notably, chronic kidney disease increases morbidity and mortality
.
Most people with chronic kidney disease die from cardiovascular complications, which usually precede end-stage renal disease
.
[14 15] Once end-stage renal disease progresses, patients must undergo renal replacement therapy, such as chronic dialysis or kidney transplantation
.
[16] Chronic kidney disease is very common around the world, affecting more than 10% of the population
.
[14 15]

About EMPA-KIDNEY: A study of empagliflozin for cardio and kidney protection [2 16]

EMPA-KIDNEY (NCT03594110) is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the effect of empagliflozin on clinically relevant outcomes of renal disease progression and risk of cardiovascular death
.
The primary outcome was time to first event of cardiovascular death or renal disease progression
.
Renal disease progression refers to end-stage renal disease (requiring renal replacement therapy, such as dialysis or kidney transplantation), persistent decline in estimated glomerular filtration rate (eGFR) to <10mL/min/1.
73m2 ^, renal death or randomization Post-eGFR continued to decline by ≥40%
.
EMPA-KIDNEY is expected to enroll approximately 6,000 patients with chronic kidney disease, with or without diabetes or proteinuria
.
These patients received empagliflozin 10 mg or placebo in addition to existing standard of care
.

About Oxford University Medical Research Council (MRC) Population Health Research Unit (PHRU)

Oxford MRC PHRU (Medical Research Council), part of Oxford Population Health, aims to improve the treatment and prevention of chronic diseases, especially cardiovascular and metabolic diseases (such as diabetes and chronic kidney disease), which are Diseases collectively contribute to the burden of premature death and disability in a large proportion of adults worldwide
.
The MRC PHRU is led by Professor Colin Baigent, Co-Chair of the EMPA-KIDNEY Steering Committee
.
The MRC PHRU leads innovative clinical research and meta-analyses aimed at identifying important advances that have a significant impact on health
.
Other major studies include the groundbreaking Randomized Evaluation of Therapeutics for COVID-19 (RECOVERY) trial, co-led by Professor Martin Landray, co-chair of the EMPA-KIDNEY Steering Committee
.
MRC PHRU research has a global reach, covering a large number of people, providing reliable information on the cause of disease and the effect of treatment, and has a huge impact on global human health
.

About the EMPOWER project

The consortium developed the EMPOWER project to explore the effects of empagliflozin on key clinical cardiovascular and renal outcomes across a range of cardio-renal-metabolic diseases
.
Cardiorenal metabolic diseases are the leading cause of death worldwide, causing up to 20 million deaths each year
.
Through the EMPOWER project, Boehringer Ingelheim and Eli Lilly are working to increase understanding of these interconnected systems and develop treatments that provide comprehensive, multi-organ benefit
.
Comprising nine studies and two real-world studies, EMPEROR reinforces the alliance's long-term commitment to improving clinical outcomes for patients with cardio-renal-metabolic disease
.
With clinical studies enrolling more than 400,000 adult patients worldwide, EMPOWER is the most extensive and comprehensive clinical research program on SGLT2 inhibitors to date
.

About Heart-Kidney-Metabolic Disease

Boehringer Ingelheim and Eli Lilly hope to change the way patients are treated for heart-kidney-metabolic disease, a group of interconnected diseases that affect more than a billion people worldwide and are the leading cause of death
.
[20]

The cardiovascular, renal, and metabolic systems are interconnected and share many of the same risk factors and pathological pathways across the disease spectrum
.
Dysfunction in one system may accelerate the onset of other systems, leading to the development of related diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease that are interconnected, leading to an increased risk of cardiovascular death
.
Conversely, improving the health of one system can have a positive impact in other systems
.
[7 17 18 ]

Through our research and treatments, we aim to support people's health, restore balance between the interconnected heart-kidney-metabolic systems, and reduce their risk of serious complications
.
As part of our commitment to those whose health is compromised by cardiorenal metabolic disease, we will continue to research multidisciplinary treatment options and focus our resources on filling treatment gaps
.

About Empagliflozin

Empagliflozin (trade name Ou Tangjing) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, and is the first in many countries to include lower cardiovascular Type 2 diabetes medications with mortality risk data
.
[19 20]

About Boehringer Ingelheim and Eli Lilly

In January 2011, Boehringer Ingelheim and Eli Lilly announced a cooperation agreement, which includes several varieties of hypoglycemic drugs
.
Based on different markets, the two parties will choose to jointly promote or individually promote the drugs provided by each of them for this cooperation
.
This collaboration brings together the strengths of two leading global pharmaceutical companies focused on patient needs, and by working together, the two companies are committed to helping people with diabetes and exploring solutions to their unmet medical needs
.
Clinical trials evaluating empagliflozin in patients with heart failure or chronic kidney disease have been initiated
.

About Boehringer Ingelheim

Boehringer Ingelheim is committed to researching breakthrough treatments aimed at improving human and animal health
.
As a leading global biopharmaceutical company driven by research and development, the company delivers value through innovation in areas of high unmet medical need
.
Since its founding in 1885, Boehringer Ingelheim has remained an independent family-owned company and this will not change in the long run
.
About 52,000 employees serve more than 130 locations worldwide in three business areas: Human Medicines, Animal Health and Biopharmaceutical Contract Manufacturing
.
For more information, please visit:  

About Eli Lilly and Company

As a global leader in the healthcare industry, Lilly is committed to repaying patients with innovation and caring for life
.
For more than 140 years since its establishment, Lilly has always pursued the philosophy of providing patients with the highest quality medicines with the latest technology, which is in line with the commitment of the company's founder, Colonel Lilly
.
Today, Lilly remains committed to this mission and conducts its work accordingly
.
Lilly people around the world not only devote themselves to the development of life-saving medicines, actively help patients better understand and manage diseases, but also give back to the society through charitable activities
.
To learn more about Lilly, visit lilly.
com and lilly.
com/newsroom
.

references

[1] Herrington WG, Preiss D, Haynes R, et al.
The potential for improving cardio-renal outcomes by sodium-glucose co-transporter-2 inhibition in people with chronic kidney disease: a rationale for the EMPA-KIDNEY study.
Clin Kidney J.
2018;11(6):749–61.

[2]  The EMPA-KIDNEY Collaborative Group.
[Published online ahead of print March 3 2022].
Nephrol Dial Transplant.
2022.
DOI: 10.
1093/ndt/gfac040.