Boehringer Ingelheim and Lilly expand heart failure programme for empagliflozin with new exercise capacity trials

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced plans to expand their clinical trial programme for empagliflozin in chronic heart failure with the EMPERIAL clinical trials. These trials will evaluate the effect of empagliflozin on exercise ability and heart failure symptoms in people with chronic heart failure independent of whether they have type 2 diabetes. EMPERIAL comprises two Phase III trials that will assess the effect of 12 weeks’ treatment with empagliflozin on the ability of people with heart failure to perform daily exercise.^1,2

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The plans for the EMPERIAL trials follow initiation of the EMPEROR trials in March 2017.^3,4 While the EMPEROR outcome trials focus on long-term morbidity and mortality outcomes in people with heart failure, the EMPERIAL functional trials will investigate possible benefits on exercise capacity and heart failure symptoms.^3,4 These studies are based on data obtained from the landmark EMPA-REG OUTCOME^® trial, where the effect of empagliflozin on heart failure outcomes was evaluated.⁵

“Symptoms of heart failure can have a profound effect on quality of life, with more than three quarters of people with heart failure finding it difficult to carry out routine activities,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. “Currently, there are limited treatment options that can help improve the everyday lives of people living with chronic heart failure. We look forward to seeing whether empagliflozin can help address this unmet need.”

Heart failure is a serious condition where the heart is unable to pump enough blood around the body.⁶ It affects 26 million people worldwide and is associated with high morbidity and mortality.⁷ Approximately 50 percent of people who develop heart failure die within five years and it is the leading cause of hospitalisation in the United States and Europe.^6,8

“In the EMPA-REG OUTCOME^® trial, it was encouraging to see a significant reduction in the risk of hospitalisation for heart failure with empagliflozin in people with type 2 diabetes and established cardiovascular disease,” said Prof Dr Martina Brückmann, Global Head of Clinical Development, Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “Boehringer Ingelheim and Lilly will conduct the EMPERIAL trials to investigate whether empagliflozin could also improve daily exercise and quality of life for people with chronic heart failure with or without type 2 diabetes.”

About EMPERIAL

EMPERIAL consists of two Phase III randomised, double-blind trials. The trials evaluate the effect of 12 weeks treatment of once daily empagliflozin 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* This will be measured by the 6-minute walk test, a common measure of functional exercise capacity.

• EMPERIAL-preserved [NCT03448406]: will investigate empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looks at a functional endpoint: how far patients can walk in 6 minutes and at heart failure symptoms.¹
  • Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
  • Anticipated number of patients: approx. 300
  • Estimated completion: 2019
• EMPERIAL-reduced [NCT03448419]: will investigate empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looks at a functional endpoint: how far patients can walk in 6 minutes and at heart failure symptoms.²
  • Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
  • Anticipated number of patients: approx. 300
  • Estimated completion: 2019

*Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.⁹

HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart.¹⁰

HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.¹⁰

Both, HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling, and fatigue.

About Heart Failure

Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body.⁶ Symptoms of heart failure include difficulty breathing, swelling, and fatigue amongst others.¹¹ Heart failure is a prevalent disease; 26 million people around the world have chronic heart failure.⁷ There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years.⁸ Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the United States and Europe.⁷ Heart failure is highly prevalent in people with diabetes;¹² however, approximately half of all people with heart failure do not have diabetes.^7,13

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 reduction data in the label in several countries.^14,15,16

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 (i.e. sodium) and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). The glucosuria, natriuresis and osmotic diuresis observed with empagliflozin may contribute to the improvement in cardiovascular outcomes.

Empagliflozin is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/EMPERIAL-heart-failure

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Contact information

Boehringer Ingelheim
Dr Petra Kienle
Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Eli Lilly and Company
Grant Smith
Manager, Global Business Communications
Email: grant.smith@lilly.com
Phone: +1 (317) 954 9907