Boehringer Ingelheim and Eli Lilly have commenced first ever trial to evaluate Jardiance (empagliflozin) in people hospitalised for acute heart failure who have been stabilised.
The Empulse, which is the sixth phase III study in the Jardiance heart failure programme, will evaluate whether in-hospital administration of Jardiance 10mg daily enhances heart failure outcomes when initiated in people hospitalised for any type of acute heart failure event once they have been stabilised.
Jardiance is a prescription medicine used along with diet and exercise to reduce lower blood sugar in adults with type 2 diabetes. It can also be used to minimise the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
The sixth phase III trial will comprise of participants both with and without type 2 diabetes.
According to Lilly, the primary outcome of the study will be a net clinical benefit, time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS).
Empulse is part of the empagliflozin heart failure programme, which also includes Emperor-Reduced, Emperor-Preserved, Emperial- Preserved and Emperial-Reduced, and Empa-Vision studies.
The trials are assessing the effects of empagliflozin on heart failure-related outcomes and functional capacity in over 9,500 adults with heart failure, including those with and without diabetes.
The Empulse is a multicentre, randomised, double-blind and 90-day superiority study designed to assess the effect on clinical benefit, safety and tolerability of once-daily oral EMPagliflozin 10mg compared to placebo, initiated in patients hospitalised for acute heart failure (de novo or decompensated chronic HF) who have been stabilised.
Boehringer Ingelheim Pharmaceuticals clinical development and medical affairs vice president Dr Mohamed Eid said: “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.
“The study aims to address an unmet need and is an important addition to our broad and comprehensive heart failure program.”
In October this year, Eli Lilly secured approval from the US Food and Drug Administration (FDA) for its Reyvow (lasmiditan) for the acute treatment of migraine.