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Treatment with empagliflozin (Jardiance) improved outcomes for hospitalized adults with acute heart failure (HF), according to results from the EMPULSE trial.

Among 530 adults who were stabilized in-hospital after being admitted with acute HF symptoms, those who were given the SGLT2 inhibitor were significantly more likely to have "clinical benefits" over the next 90 days versus patients on placebo (53.9% vs 38.7%, respectively; P=0.0054), reported Adriaan Voors, MD, PhD, of the University Medical Centre Groningen in The Netherlands.

Clinical benefits -- the trial's primary composite endpoint -- included a reduction in all-cause mortality, reduction in HF events, or an improvement in HF symptoms, he said in a presentation at the American Heart Association (AHA) virtual meeting.

For the various components of the endpoint, all-cause mortality within the 90-day treatment period was lower in the empagliflozin arm compared with the placebo arm (4.2% vs 8.3%), there were fewer HF events (10.6% vs 14.7%, respectively), and favorable changes were observed on the Kansas City Cardiomyopathy Questionnaire (35.9% vs 27.5%).

"This is the first time we have really seen this type of medication work so effectively and safely in patients who were hospitalized for acute heart failure, regardless of heart failure history or diabetes status," Voors said at an AHA press conference. "These results may lead to earlier and more frequent treatment with empagliflozin, which may improve the lives of more people with heart failure."

Empagliflozin is an SGLT2 inhibitor that showed benefits in cardiovascular disease, and chronic HF in particular, in several earlier trials, including , , and . Acute HF is characterized by pulmonary edema that requires urgent treatment. Even after discharge, these patients are at a greater risk of death, re-hospitalization and a lower quality of life, Voors explained.

"Even though there are several medicines available to improve clinical outcomes in patients with chronic heart failure, very few medicines have proven to benefit patients with new, acute onset of heart failure needing hospitalization," he stated. "Our findings indicate that empagliflozin may help to improve outcomes for these patients without an increase in serious adverse events [AEs]."

AHA press conference moderator Elaine Hylek, MD, MPH, of Boston University School of Medicine, commented that the EMPULSE results "seem exciting, and hopefully [empagliflozin] will become another addition to our armamentarium to treat these patients."

However, not everyone was fully convinced. AHA discussant Sana Al-Khatib, MD, of Duke University Medical Center in Durham, North Carolina, said she was concerned about the use of the composite endpoint.

"Not all these measures have the same weight, and perhaps the weight of some of the parts of the composite may vary as to what is most important and what is least important," she stated.

Al-Khatib also noted that, while the study found consistency within subgroups, the relatively small patient population would mean that the statistical power for those subgroups would be significantly reduced. She emphasized that "we certainly need more data on these patients in the setting of acute heart failure. This trial is important, and hopefully these results will encourage more research in this area."

EMPULSE participants had an average age of 68, and two-thirds were men. A little over 45% had diabetes. The mean baseline left ventricular ejection fraction (LVEF) was 35.1%, and a little less than a third had a LVEF >40%. They were randomized 1:1 to receive either a 90-day supply of 10 mg empagliflozin or 90 days of placebo pills.

In terms of AEs, there were no effects of ketoacidosis, and no cases of hypotension, according to Voors. There were some patients who experienced a drop in renal function but that resolved after 15 days, he added.

Voors stated that EMPULSE should reassure clinicians that empagliflozin is safe enough to start early in the hospital, and told MedPage Today that "I would expect that we would see similar results with other SGLT2 inhibitors."

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