Boehringer Ingelheim and Eli Lilly are expanding their clinical trial programme for Jardiance in chronic heart failure (CHF) with two new Phase III studies.
The Emperial clinical trial programme will assess the effect of 12 weeks’ treatment with Jardiance (empagliflozin) on exercise ability and heart failure symptoms in people with CHF, independent of whether they have type II diabetes.
The move follows initiation of the EMPEROR trials last year, which focused on long-term morbidity and mortality outcomes in people with heart failure, as well as data from the landmark EMPA-REG OUTCOME trial, which showed that the drug cut the risk of cardiovascular death in adults with type II diabetes and established cardiovascular disease, independent of blood sugar control at the start of the study.
A reduction in cardiovascular death was also seen when Jardiance was added to common first and second-line diabetes medications, such as metformin or sulfonylurea.
“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,” noted Thomas Seck, vice president of Clinical Development and Medical Affairs – Primary Care, Boehringer Ingelheim Pharmaceuticals.
Heart failure affects 26 million people worldwide and is associated with high morbidity and mortality.
“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, 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 Jardiance can help address this unmet need.”
Jardiance belongs to the SGLT2 inhibitor class of medicines, which also includes Johnson & Johnson's Invokana (canagliflozin) and AstraZeneca Forxiga (dapagliflozin).