Boehringer Ingelheim and Eli Lilly and Company have announced plans to expand their clinical trial programme for Jardiance® in chronic heart failure with the EMPERIAL clinical trials.
These trials will evaluate the effect of Jardiance 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 of treatment with Jardiance on the ability of people with heart failure to perform daily exercise.
The plans for the EMPERIAL trials follow initiation of the EMPEROR trials in March 2017. 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.
These studies are based on data obtained from the landmark EMPA-REG OUTCOME® trial, where the effect of Jardiance on heart failure outcomes was evaluated.
Heart failure is a serious condition where the heart is unable to pump enough blood around the body. It affects 26 million people worldwide, including more than 6 million Americans, and is associated with high morbidity and mortality. Approximately 50% of people who develop heart failure die within five years, and it is a leading cause of hospitalisation in the United States and Europe.
Dr Jeff Emmick, vice president, Product Development, Lilly Diabetes, said: “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.
“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 Jardiance can help address this unmet need.”
Dr Thomas Seck, vice president of Clinical Development and Medical Affairs – Primary Care, Boehringer Ingelheim Pharmaceuticals“, said: Boehringer Ingelheim and Lilly are committed to exploring how Jardiance can improve patient health outcomes and fill treatment gaps to serve as a broad cardiometabolic treatment option. We were encouraged by the heart failure findings with Jardiance in the EMPA-REG OUTCOME trial and look forward to the additional data from our other ongoing trials.”