Breakthrough Results Confirm Empagliflozin as First, Only Successful Trial for Heart Failure with Preserved Ejection Fraction

The new results add to earlier findings from the EMPEROR-Reduced phase 3 trial, which found that empagliflozin reduced the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% compared to placebo.

New breakthrough results have confirmed that the EMPEROR-Preserved phase 3 trial of empagliflozin met its primary endpoint, establishing empagliflozin as the first and only therapy to significantly reduce the risk of the composite of cardiovascular death or hospitalization for heart failure with preserved ejection fraction (HFpEF), according to a press release from Eli Lilly.

When added to the results from the EMPEROR-Reduced trial, these findings demonstrate the efficacy of empagliflozin in all forms of heart failure and in patients both with and without diabetes, according to the study authors. The safety profile was generally consistent with the known safety profile of the drug.

“No new therapies have been clinically proven to improve outcomes specifically for people with HFpEF, leaving a significant unmet need in this already prevalent and increasingly common form of heart failure,” said Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs, cardio-metabolism and respiratory medicine at Boehringer Ingelheim Pharmaceuticals, in a press release. “The totality of the data from the EMPEROR-Preserved trial marks a possible new chapter in heart failure, supporting the potential of Jardiance to become the first [sodium-glucose cotransporter-2 (SGLT2)] inhibitor to treat a defined population of adults with heart failure with either preserved or reduced ejection fraction.”

Heart failure poses a significant global disease burden with more than 60 million patients globally, half of whom have HFpEF. Heart failure is a leading cause of hospitalization and is increasingly prevalent in Western countries with aging populations.

Furthermore, the risk of death in individuals with heart failure increases with each hospital admission. Heart failure with the left ventricular preserved ejection fraction occurs when the left ventricle is unable to fill properly, resulting in less blood pumped throughout the body.

“HFpEF has long been the most challenging form of heart failure to treat,” said Stefan Anker, MD, PhD, principal investigator of EMPEROR-Preserved, in the press release. “Building on previous results from the EMPA-REG OUTCOME trial, and the EMPEROR-Reduced trial in heart failure with reduced ejection fraction (HFrEF), the EMPEROR-Preserved findings demonstrate that empagliflozin reduces cardiovascular death or hospitalization for heart failure and has the potential to transform the care of people living with heart failure.”

The new results add to earlier findings from the EMPEROR-Reduced phase 3 trial, which found that empagliflozin reduced the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% compared to placebo in adults with HFrEF. These studies demonstrate the benefits of empagliflozin for patients across the full spectrum of heart failure, according to the study.

The EMPEROR-Preserved trial investigated empagliflozin compared with placebo in 5988 patients with chronic HFpEF. The primary endpoint was the time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure.

Empagliflozin is not yet approved for the treatment of heart failure in the United States, although a supplemental New Drug Application to reduce the risk of cardiovascular death, hospitalization, or heart failure in adults with HFrEF has been submitted to the FDA, with a decision expected later in 2021 according to the press release.

REFERENCE

Breakthrough results for Jardiance (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction. News release. Eli Lilly and Co. July 6, 2021. Accessed July 6, 2021. http://lilly.mediaroom.com/2021-07-06-Breakthrough-results-for-Jardiance-R-empagliflozin-confirm-EMPEROR-Preserved-as-first-and-only-successful-trial-for-heart-failure-with-preserved-ejection-fraction