The EMPULSE study is a multi-centre, randomised, double-blind study to assess the oral EMPagliflozin 10mg compared to placebo
Image: Eli Lilly and Company's corporate centre in Indianapolis, Indiana, US. Photo: Courtesy of Momoneymoproblemz/Wikipedia.
German pharmaceutical firm Boehringer Ingelheim and US-based Eli Lilly have partnered to initiate EMPULSE program, the sixth phase III study of Jardiance (empagliflozin) for heart failure.
The study is aimed at evaluating the in-hospital administration of Jardiance 10mg daily for improving heart failure outcomes in people hospitalised for any type of acute heart failure, after being stabilized.
Jardiance is a prescription medicine, which is advised to be taken along with diet and exercise, to lower blood sugar in adults with type 2 diabetes.
The drug is also used for reducing the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease, and is not indicated for people with type 1 diabetes or diabetic ketoacidosis.
EMPULSE study will enrol participants with and without type 2 diabetes
The EMPULSE study is a multi-centre, randomised, double-blind, 90-day superiority study to assess the effect on clinical benefit, safety and tolerability of once-daily oral EMPagliflozin 10mg compared to placebo, in patients hospitalized for acute heart failure, after being stabilised.
Net clinical benefit, composite of all-cause mortality, number of heart failure events including hospitalizations, urgent heart failure visits and unplanned patient visits constitute the primary end points of the study.
In addition, time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), an instrument used for measuring the disease-specific quality of life in heart failure are also the part of primary end points.
EMPULSE program is part of the empagliflozin heart failure program, which also includes the EMPEROR-Reduced and EMPEROR-Preserved, EMPERIAL-Preserved and EMPERIAL-Reduced, and EMPA-VISION studies, assessing the effects of empagliflozin on heart failure-related outcomes and functional capacity.
Boehringer Ingelheim Pharmaceuticals cardio-metabolism and respiratory medicine clinical development and medical affairs vice president 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.”