Eli Lilly and Boehringer Ingelheim have started a Phase III clinical trial, EMPULSE, to evaluate whether Jardiance (empagliflozin) improves acute heart failure.
Jardiance is an inhibitor of sodium glucose cotransporter 2 (SGLT2) and is indicated to lower blood sugar in adults with type 2 diabetes when used with diet and exercise.
The drug is also intended to mitigate the risk of cardiovascular death in type 2 diabetes patients with known cardiovascular disease.
EMPULSE is a multi-centre, randomised, double-blind, superiority trial designed to compare the safety, tolerability and clinical benefit of once-daily, 10mg empagliflozin with placebo in hospitalised patients.
The study is set to enrol nearly 500 acute heart failure patients with or without type 2 diabetes. EMPULSE will help the companies investigate Jardiance’s ability to improve outcomes in these patients.
Heart failure is known to be responsible for one in nine deaths but has limited treatment options. Hospitalised patients have a 15% mortality and 30% readmission rate within 60 to 90 days of discharge.
Initiation of treatment in the hospital is expected to yield long-term improved prognosis and patient treatment adherence.
The primary endpoint of the trial is net clinical benefit determined as a composite of the number of heart failure events, all-cause mortality, time to first heart failure event, and change in Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS) following 90 days of therapy.
Boehringer Ingelheim Pharmaceuticals Cardio-Metabolism & Respiratory Medicine clinical development 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 hospitalised for acute heart failure.
“The study aims to address an unmet need and is an important addition to our broad and comprehensive heart failure programme.”
Apart from EMPULSE, empagliflozin’s heart failure programme includes EMPEROR-Reduced, EMPEROR-Preserved, EMPERIAL-Preserved, EMPERIAL-Reduced and EMPA-VISION studies conducted in more than 9,500 patients.
Lilly and Boehringer partnered in January 2011 to develop multiple compounds for diabetes treatment.