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2017-03-20 09:25
First dedicated outcome trials of empagliflozin in chronic heart failure initiated
  • EMPEROR HF clinical trial programme will evaluate the efficacy and safety of empagliflozin in patients with chronic heart failure, including those with and without type 2 diabetes
    Heart failure (HF) affects 26 million people worldwide and is associated with high morbidity and mortality
    EMPEROR HF will include approximately 7,000 patients with chronic heart failure across two trials
INGELHEIM, GERMANY & INDIANAPOLIS, US--(Business Wire/Korea Newswire) March 20, 2017 -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that the EMPEROR HF clinical trial programme was initiated. EMPEROR HF comprises two Phase III outcome studies that will investigate empagliflozin for the treatment of people with chronic heart failure. The trials will involve not only people with type 2 diabetes, who have heart failure, but also heart failure patients who do not have diabetes.

Heart failure is a condition where the heart cannot pump enough blood around the body, and is associated with high morbidity and mortality. Worldwide, there are approximately 26 million people suffering from heart failure. It is the leading cause of hospitalisation in the United States and Europe, with more than one million admissions annually for heart failure as primary diagnosis. Readmission rates after a hospital stay for heart failure are as high as 30 percent within 60 to 90 days, and approximately 50 percent of patients diagnosed with heart failure will die within five years.

“Heart failure is a global health burden. We need to explore new treatment options, especially for those types of heart failure where treatments are currently limited,” said Professor Milton Packer, MD, Baylor Heart and Vascular Institute, Baylor University Medical Center, USA, lead investigator of both trials. “The EMPA-REG OUTCOME® trial demonstrated a significant reduction in the risk of cardiovascular death with empagliflozin in people with type 2 diabetes and cardiovascular disease. And now these new EMPEROR HF clinical trials will take a dedicated look at the effects of empagliflozin in heart failure patients.”

Jardiance® (empagliflozin) is the first type 2 diabetes medicine to have data on the reduction of the risk of cardiovascular (CV) death included in the label in several countries. The EMPA-REG OUTCOME® trial demonstrated that Jardiance® reduced the risk of CV death by 38 percent versus placebo in patients with type 2 diabetes and established CV disease when added to standard of care (including glucose-lowering agents and CV drugs). As one of the secondary endpoints, the trial also showed a reduction in the risk of hospitalisation for heart failure by 35 percent with Jardiance® in this patient population.

Heart failure can be categorised by ejection fraction, a measurement used to determine how well the heart pumps blood around the body. The EMPEROR HF programme consists of two event-driven Phase III clinical trials that will investigate empagliflozin for the treatment of people with chronic heart failure with either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF). Both trials will assess the impact of treatment with empagliflozin on CV death and hospitalisation for heart failure as primary endpoints. The two trials will involve approximately 7,000 patients in total and are anticipated to complete in 2020.

“Despite currently available therapies, about half of people who develop heart failure die within five years of diagnosis. This highlights a real need for progress in the treatment of this condition,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Therapeutic Area Metabolism, Boehringer Ingelheim. “Our new studies aim to explore the potential of empagliflozin for patients affected by heart failure. At the same time, these studies mark the first time empagliflozin will be evaluated in people without type 2 diabetes. So we are very excited about the initiation of these two new studies.”

About the EMPEROR HF Clinical Trial Programme

The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) HF clinical trial programme will investigate once daily empagliflozin, compared to placebo, in heart failure patients, both with and without type 2 diabetes receiving current standard of care. The programme comprises the following two Phase III, randomised, double-blind trials which assess heart failure in patients with preserved ejection fraction or patients with reduced ejection fraction*:

· EMPEROR HF-Preserved [NCT03057951]: will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Primary endpoint: time to first event of adjudicated CV (cardiovascular) death or adjudicated HHF (Hospitalisation for Heart Failure) [Time Frame: up to 38 months]
Anticipated number of patients: approx. 4,100
Estimated completion: 2020

· EMPEROR HF-Reduced [NCT03057977]: will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
Primary endpoint: time to first event of adjudicated CV (cardiovascular) death or adjudicated HHF (Hospitalisation for Heart Failure) [Time Frame: up to 38 months]
Anticipated number of patients: approx. 2,800
Estimated completion: 2020

*Ejection fraction is a measurement of the percentage of blood leaving your 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.

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.

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.

About Heart Failure

Heart failure is a debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body. Heart failure is a prevalent disease; 26 million people around the world have chronic heart failure. There is a high unmet need in the treatment of heart failure as there remains a significant morbidity and mortality associated with the condition. It is the leading cause of hospitalisation in the United States and Europe, with over one million admissions. Readmission rates after a hospital stay for heart failure are as high as 30 percent within 60 to 90 days, and approximately 50 percent of patients diagnosed with heart failure will die within five years. Heart failure is highly prevalent in patients with diabetes; however, approximately half of all heart failure patients do not have diabetes.

About Jardiance®

Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium-glucose co-transporter-2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death reduction data in the label in several countries.

Inhibition of SGLT2 with Jardiance® (empagliflozin) in patients with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of Jardiance® increases excretion of salt (i.e. sodium) from the body and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Excretion of sugar, salt and water after the initiation of treatment with empagliflozin may therefore contribute to the improvement in cardiovascular outcomes.

Jardiance® is not approved for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (metabolic disorder with increased ketones in the blood or urine).

Intended Audiences

This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/empagliflozin-chronic-heart-failure-outcome-trials-initiated

View source version on businesswire.com: http://www.businesswire.com/news/home/20170317005262/en/
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