Boehringer Ingelheim and Lilly initiate first ever study to assess Jardiance® in people hospitalized for acute heart failure who have been stabilized
– EMPULSE is a superiority study that will assess the clinical benefit, safety and tolerability of 10 mg daily Jardiance® (empagliflozin) in acute heart failure RIDGEFIELD , Conn. and INDIANAPOLIS , Nov. 12, 2019 /PRNewswire/ — Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced the initiation of EMPULSE, the sixth phase III study in the Jardiance® (empagliflozin) heart failure program. The study will assess whether in-hospital administration of Jardiance 10 mg daily improves heart failure outcomes when initiated in people hospitalized for any type of acute heart failure event once they have been stabilized. The study will include participants both with and without type 2 diabetes.
Heart failure contributes to one in nine deaths and is a leading cause of hospitalization in the U.S., yet there are limited treatment options for people living with this debilitating disease. Outcomes for patients after they have been hospitalized for heart failure are poor, with a 15 percent mortality and 30 percent readmission rate within 60 to 90 days of discharge from the hospital. Initiating treatment in the hospital is one of the best predictors of long-term improved prognosis and patient treatment adherence. The EMPULSE study aims to understand whether Jardiance has the potential to improve outcomes in this population.
“Acute decompensated heart failure is one of the fastest-growing diseases in the world and a leading cause of hospital admissions worldwide with high short term mortality and rehospitalization. Unlike chronic heart failure, there is no established therapy available that improves clinical outcomes in acute heart failure,” said Adriaan Voors, Professor of Cardiology, University Medical Center Groningen, Netherlands. “The beneficial effects of SGLT2 inhibitors, as seen in three large randomized trials in type 2 diabetes patients, are thought to be at least partly explained by the diuretic/natriuretic effects of SGLT2 inhibitors. The EMPULSE study will investigate whether Jardiance, due to its mode of action, can alleviate symptoms associated with heart failure and improve outcomes after discharge from the hospital.”
The primary outcome of the study will be net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalizations, urgent heart failure visits and unplanned patient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS), an instrument for measuring disease-specific quality of life in heart failure.
“We are particularly delighted to announce the addition of EMPULSE as the first-ever study to assess the effects of Jardiance in people who have been hospitalized for acute heart failure,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “The study aims to address an unmet need and is an important addition to our broad and comprehensive heart failure program.”
EMPULSE is part of the empagliflozin heart failure program, which also consists of the EMPEROR-Reduced and EMPEROR-Preserved, EMPERIAL-Preserved and EMPERIAL-Reduced, and EMPA-VISION studies. These studies are investigating the effects of empagliflozin on heart failure-related outcomes and functional capacity in more than 9,500 adults with heart failure, including those with and without diabetes.
About EMPULSE (NCT04157751)
The EMPULSE study is a multicenter, randomized, double-blind, 90-day superiority study to evaluate the effect on clinical benefit, safety and tolerability of once-daily oral EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalized for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilizEd (EMPULSE).
- Primary endpoint: Net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalizations for heart failure, urgent heart failure visits and unplanned outpatient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS) after 90 days of treatment
- Anticipated number of patients: approx. 500
About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body’s demands for oxygenated blood or, to do so, requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues. It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.
Symptoms of heart failure include difficulty breathing, swelling – most commonly in feet, legs and ankles – and fatigue, among others. People with heart failure experience a substantial reduction in quality of life, approximately 76 percent of whom find it difficult to carry out usual activities. This is, in part, due to the limitation of physical activity.
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. Additionally, heart failure represents the most common cause of hospitalization among individuals aged 65 years and over in the U.S. and Europe.
About Cardiorenal Metabolic Conditions
Cardiorenal metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.
Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. A team approach to optimize patient care by coordinating treatment of related comorbidities, including the use of emerging therapies with broad cardiorenal metabolic effects, may improve outcomes for people with serious chronic conditions such as these.