恩格列净治疗急性心衰成年患者可使临床获益

Introduction: Compared with placebo, adult patients hospitalized for acute heart failure were 36% more likely to have a clinical benefit for more than 90 days if they took empagliflozin after stabilization and before discharge.

This benefit was consistent among adults with new or existing heart failure and among adults with preserved or reduced ejection fraction.

On March 1, 2022, Boehringer Ingelheim and Eli Lilly announced that results from the Phase III EMPULSE clinical trial showed that compared with placebo, if adult patients with acute heart failure were treated with empagliflozin (Jardiance®) after stabilization and before discharge, the likelihood of clinical benefit for more than 90 days increased by 36%. Clinical benefit reflected a composite primary endpoint that included all-cause mortality, frequency of heart failure events, time to first heart failure event and symptoms as measured by the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS). The findings were published in the journal Nature Medicine and presented at the 2021 American Heart Association's Latest Scientific Sessions.

Adriaan Voors, professor of cardiology at the University Medical Center Groningen in the Netherlands and principal investigator of EMPULSE, said: "The first few months after hospitalization for heart failure are a particularly vulnerable time for patients. The current poor prognosis highlights the urgent need to improve the clinical management of hospitalized patients to prevent further hospitalization or death. The significant clinical benefit of empagliflozin compared with placebo will advance our understanding of the treatment of patients with heart failure early after hospital discharge."

In the United States, more than 1 million people are hospitalized for heart failure each year. The U.S. National Readmissions Database shows that patients hospitalized for heart failure have poor prognosis after discharge, with more than 30% of patients being readmitted within 90 days between 2010 and 2017.

The overall clinical benefit of empagliflozin was consistent in patients with new or existing heart failure, patients with diabetes or without diabetes, and patients with preserved or reduced ejection fraction. In the exploratory secondary endpoint study, empagliflozin resulted in a significant improvement in KCCQ-TSS scores of 4.5 points from baseline to day 90 compared with placebo.

The safety results of the EMPULSE trial are consistent with the established safety profile of empagliflozin. The study reported that the incidence of acute renal failure was 7.7% in the empagliflozin group and 12.1% in the placebo group. The incidence of hypoglycemia was similar in both groups (1.9% in the empagliflozin group and 1.5% in the placebo group). The volume consumption rates are 12.7% and 10.2% respectively.

Mohamed, Vice President, Clinical Development and Medical Affairs, Cardiometabolic and Respiratory Medicine, Boehringer Ingelheim "We are excited about the early and significant clinical benefits shown by empagliflozin in adults with heart failure, both with preserved and reduced ejection fraction, including improvements in endpoints of mortality, hospitalizations and quality of life," said Eid. "We remain committed to trials like this one that help us better understand how this therapy can benefit people with a range of cardiorenal and metabolic diseases for whom additional treatment options are in great need."

"The results from the EMPULSE trial add to our EMPOWER program's growing body of evidence supporting the potential role of empagliflozin in a range of conditions affecting the heart, kidneys and metabolic system," said Jeff Emmick, MD, vice president of product development at Eli Lilly. "The clinical benefit and consistent safety results during the fragile period after discharge suggest that treating appropriate patients with empagliflozin during these critical months can improve outcomes."

Recently, the U.S. Food and Drug Administration (FDA) approved empagliflozin to reduce the risk of cardiovascular death and heart failure hospitalization in adults with heart failure based on data from the EMPEROR-Preserved® trial. This decision marks the U.S. FDA’s third approval of empagliflozin in the EMPOWER project.

On February 25, 2022, the FDA approved empagliflozin to treat a wider range of heart failure types, including patients with heart failure with preserved ejection fraction (HFpEF), who have a poor prognosis and very limited treatment options. In 2014, the FDA approved empagliflozin to improve blood sugar control in adults with type 2 diabetes as a supplement to diet and exercise. In August 2021, the FDA approved its use to reduce the risk of cardiovascular death and heart failure hospitalization in adult heart failure patients with reduced ejection fraction, regardless of whether they have diabetes.