Empagliflozin (Jardiance), already shown to offer benefits to adults with chronic heart failure, can also improve outcomes for adults hospitalized with acute heart failure, according to findings presented at the American Heart Association virtual meeting.
In this exclusive video, lead author , of the University Medical Centre Groningen in The Netherlands, discusses the background and results of the .
Following is a transcript of his remarks:
EMPULSE is a unique trial in the sense that we have seen beneficial effects of SGLT2 inhibitors in chronic heart failure, as well as in diabetics, but mainly also chronic heart failure, chronic heart failure with reduced and preserved ejection fraction -- so EMPEROR trials: Preserved and EMPEROR-Reduced, DAPA-HF. So in that sense, it's different because it's in acute heart failure.
There has been one trial in acute heart failure, which is SOLOIST. That was a semi-acute heart failure trial. Some of the patients were recruited pre-discharge and some post-discharge. And that SOLOIST trial only included patients with diabetes.
EMPULSE is unique in a way that it studies patients hospitalized for acute heart failure, irrespective of whether they had diabetes or not, irrespective of whether they have rEF heart failure with reduced or preserved ejection fraction. And irrespective of whether they had been diagnosed with heart failure before or not, could also be the first presentation of heart failure.
So, the study enrolled 530 patients all hospitalized for acute decompensated heart failure or de novo acute heart failure. And patients were randomized to the placebo or empagliflozin 10 mg per day after 1 to 4 days, so after stabilization in hospital.
The primary endpoint was a clinical composite endpoint, which comprised death, heart failure events, or improvement in quality-of-life total symptom score, and it was assessed by win ratio. And the win ratio revealed that patients treated with empagliflozin were 36% more likely to obtain a clinical benefit. And if we look at the separate components, so first of all death or heart failure events, we can see a 35% reduction in death or heart failure events. And it was a more than 4.5 increase in quality-of-life Kansas City Cardiomyopathy Questionnaire-Total Symptom Score -- so both reduction of events, as well as improvement in quality of life.