Boehringer, Lilly start acute heart failure trial with Jardiance

Boehringer and Eli Lilly have started a large-scale trial of their diabetes drug Jardiance in acute heart failure, seeking to get ahead of rivals such as AstraZeneca.

The new study - called EMPULSE – will see if Jardiance (empagliflozin) can improve survival and other clinical outcomes in people hospitalised for acute heart failure who have been stabilised on standard therapies.

SGLT2 inhibitors such as Jardiance and AstraZeneca’s Forxiga/Farxiga (dapagliflozin) are starting to make waves for their potential in treating chronic heart failure, but Boehringer and Lilly are treading new ground for the class with a study that focuses on acute, in-hospital treatment.

In the study, Jardiance will be given at a 10mg daily dose to patients with any type of acute heart failure, either with or without type 2 diabetes, to see if it can reduce a composite of all-cause mortality, number of heart failure events, time to first heart failure event and declines in quality-of-life scores.

It extends Boehringer and Lilly’s EMPEROR and EMPERIAL heart failure studies for Jardiance, which also includes studies in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF), as well as the EMPA-VISION trial that will look at cardiac changes in chronic heart failure.

Earlier this year, Farxiga became the first drug in the SGLT2 inhibitor to be approved to reduce the chances of hospitalisations for heart failure in adults with type 2 diabetes and other cardiovascular risks, based on the results of the DECLARE-TIMI 58 trial.

Meantime, AZ also picked up a fast-track designation from the FDA for Farxiga as a treatment to reduce risk of cardiovascular death, or worsening of heart failure – in adults with HFrEF or HFpEF with or without diabetes – on the back of positive results from the phase 3 DAPA-HF and DELIVER studies.

The EMPULSE trial plays to the fact that outcomes for patients who have been hospitalised for heart failure are notoriously poor, with a 15% mortality and 30% readmission rate within 60 to 90 days of being discharged.

If Jardiance is shown to be effective early in the acute setting, that could encourage greater use of the drug outside the hospital setting in chronic heart failure.

“Acute decompensated heart failure is one of the fastest-growing diseases in the world and a leading cause of hospital admissions worldwide with high short term mortality and rehospitalisation,” commented Adriaan Voors of University Medical Center Groningen in the Netherlands.

“Unlike chronic heart failure, there is no established therapy available that improves clinical outcomes in acute heart failure,” he added.

Jardiance is the market leader in the SGLT2 inhibitor category with sales of $2.7 billion last year, driven by data showing that it can improve cardiovascular outcomes in diabetics from the EMPA-REG OUTCOME study.

It made almost twice the $1.4 billion booked in Farxiga sales in that year, but AZ’s drug is expected to gain ground thanks to cardiovascular and kidney outcomes data and the new heart failure indication.