- EMPEROR HF clinical trial program will evaluate the efficacy and safety of empagliflozin in patients with chronic heart failure, including those with and without type 2 diabetes
- Heart failure affects 26 million people worldwide, and 5.7 million people in the U.S., and is associated with high morbidity and mortality
- EMPEROR HF will include approximately 7,000 patients with chronic heart failure across two trials
RIDGEFIELD, Conn. and INDIANAPOLIS, March 17, 2017 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that the EMPEROR HF clinical trial program was initiated. EMPEROR HF comprises two phase III outcome studies that will investigate empagliflozin for the treatment of adults with chronic heart failure. The trials will involve not only adults 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. Approximately 26 million people worldwide, and 5.7 million people in the U.S. suffer from heart failure. It is the leading cause of hospitalizations in the United States and Europe, with more than 1 million admissions annually for heart failure as the 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 adults 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 approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. EMPA-REG OUTCOME demonstrated that JARDIANCE reduced the risk of cardiovascular death by 38 percent versus placebo in patients with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs). As one of the secondary endpoints, the trial also showed a reduction in the risk of hospitalization for heart failure by 35 percent with JARDIANCE in this patient population. These data are not included in the current JARDIANCE label.
Heart failure can be categorized by ejection fraction, a measurement used to determine how well the heart pumps blood around the body. The EMPEROR HF program consists of two event-driven phase III clinical trials that will investigate empagliflozin for the treatment of adults with chronic heart failure with either preserved ejection fraction or reduced ejection fraction. Both trials will assess the impact of treatment with empagliflozin on cardiovascular death and hospitalization 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 5 years of diagnosis. This highlights a real need for progress in the treatment of this condition," said Prof. 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."
JARDIANCE is not for people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).
About the EMPEROR HF Clinical Trial ProgramRead More
(All Rights Reserved)