IN-BOEHRINGER-INGELHEIM

Empagliflozin reduced the risk of total (first plus recurrent) cardiovascular events compared with placebo, when both were given on top of standard of care, in adults with type 2 diabetes and established cardiovascular disease over the three years of the EMPA-REG OUTCOME^® trial, according to results of a new post-hoc analysis. Total cardiovascular events included 3P-MACE (a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death), hospitalization for heart failure and all-cause hospitalization. The findings, announced by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), were published in The Lancet Diabetes & Endocrinology. ²

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“People with type 2 diabetes and established atherosclerotic cardiovascular disease are at an increased risk of cardiovascular complications often requiring recurrent admissions to hospital, imposing a significant burden on quality of life for patients and on healthcare systems,” said Darren McGuire, M.D., M.H.Sc., lead author of the analysis and Professor of Medicine at the University of Texas Southwestern Medical Center and Parkland Health and Hospital System. “Considering the totality of hospitalization events, as opposed to just the first event that is most commonly analyzed in clinical trials, better reflects the net effect of beneficial therapies. These new findings help us understand the impact of long-term treatment with empagliflozin for adults who may experience recurrent events due to these debilitating conditions.”

Previously, the landmark EMPA-REG OUTCOME^® trial showed that, in adults with type 2 diabetes and established cardiovascular disease, empagliflozin reduced the relative risk of 3P-MACE by 14 percent, driven by a 38 percent reduction in the relative risk of cardiovascular death.³

These new exploratory analyses show that, when added to standard of care, empagliflozin reduced the relative risk of the following total (first plus recurrent) events versus placebo:²

• 3P-MACE by 22 percent
• Hospitalizations for heart failure by 42 percent
• All-cause hospitalizations by 17 percent
• Fatal or non-fatal myocardial infarction, commonly known as heart attack, by 21 percent
• Coronary heart disease events (a composite of myocardial infarction and coronary revascularization) by 20 percent.

“These new findings add to previous evidence of the ability of empagliflozin to reduce cardiovascular and all-cause mortality, and in fact suggest additional positive effects of empagliflozin on hospitalization and atherosclerosis-related outcomes in people with type 2 diabetes with established cardiovascular disease,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.

“Boehringer Ingelheim and Lilly will continue to explore how empagliflozin can potentially improve health outcomes and fill treatment gaps for adults with type 2 diabetes and heart disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “We look forward to presenting further results from our EMPOWER program, which is one of the largest cardiovascular clinical programs for an SGLT2 inhibitor to date with more than 377,000 adults studied worldwide.”

About EMPA-REG OUTCOME^® (NCT01131676 )³

EMPA-REG OUTCOME^® was a long-term, multicenter, randomized, 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 (10 mg or 25 mg 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 medication for the treatment of hypertension and hypercholesteremia). 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 the EMPOWER program

The Alliance has developed the EMPOWER program to explore the impact of empagliflozin 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.⁴ 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 377,000 adults estimated to have enrolled worldwide upon completion of the studies, 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 failure⁵
• EMPEROR-Preserved, in adults with chronic heart failure with preserved ejection fraction to reduce the risk of cardiovascular death or hospitalization due to heart failure⁶
• EMPULSE, in adults hospitalized for acute heart failure and stabilized to improve clinical and patient reported outcomes⁷
• 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 outcomes⁸
• EMPA-KIDNEY, in adults with established chronic kidney disease to reduce the progression of kidney disease and the occurrence of cardiovascular death⁹
• EMPERIAL-Reduced, in adults with chronic heart failure with reduced ejection fraction to evaluate functional ability and patient reported outcomes¹⁰
• EMPERIAL-Preserved, in adults with chronic heart failure with preserved ejection fraction to evaluate functional ability and patient-reported outcomes¹¹
• EMPA-REG OUTCOME^® , in adults with type 2 diabetes and established cardiovascular disease to reduce the risk of major adverse cardiovascular events, including cardiovascular death³
• 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^12,13

About Type 2 Diabetes and Cardiovascular Disease

Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.¹⁴ More than 463 million people worldwide have diabetes, of which 232 million are estimated to be undiagnosed.¹⁴ By 2045, the number of people with diabetes is expected to rise to 700 million people worldwide.¹⁴ Type 2 diabetes is the most common form of diabetes.¹⁴

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes.¹⁵ One in two people with type 2 diabetes worldwide die from a cardiovascular event.¹⁶

About Cardio-Renal-Metabolic Conditions

Boehringer Ingelheim and Lilly are driven to transform 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.^17,18

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.^19,20

Through our research and treatments, our goal is to support people’s health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.

About Empagliflozin

Empagliflozin (marketed as Jardiance^® ) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first medicine approved by regulatory authorities to significantly reduce the risk of cardiovascular death or include data on the reduction of the risk of cardiovascular death in the label for adults with type 2 diabetes and established cardiovascular disease.^18,19,21

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels prevents sugar being re-absorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, initiation of empagliflozin also prevents salt being re-absorbed, leading to increased excretion of salt from the body and reducing 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.²⁰

Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/empa-reg-outcome-recurrent-events

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