Treatment with empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, significantly reduced the risk of cardiovascular (CV) death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF), according to data from the phase 3 EMPEROR-Preserved trial.
The study (ClinicalTrials.gov Identifier: NCT03057951) included 5988 adult patients with HFpEF, with and without diabetes. Patients were randomly assigned to receive either empagliflozin 10mg once daily or placebo in addition to standard of care for up to 38 months.
Findings showed that the trial met the primary endpoint demonstrating a significant reduction in risk with empagliflozin vs placebo for the composite of CV death or hospitalization for heart failure. Full trial results will be presented at the European Society of Cardiology Congress 2021 on August 27.
“No approved therapies have been clinically proven to improve outcomes specifically for people with HFpEF, leaving a significant unmet medical need in this already prevalent and increasingly common form of heart failure,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “The totality of the data from the EMPEROR-Preserved trial marks a possible new chapter in heart failure, supporting the potential of [empagliflozin] to become the first SGLT2 inhibitor to treat a defined population of adults with heart failure with either preserved or reduced ejection fraction.”
In January 2021, the Food and Drug Administration (FDA) accepted the supplemental New Drug Application (sNDA) for empagliflozin to reduce the risk of CV death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced ejection fraction (HFrEF), including those with and without type 2 diabetes. The sNDA submission was supported by data from the phase 3 EMPEROR-Reduced trial (ClinicalTrials.gov Identifier: NCT03057977), which showed that treatment with empagliflozin reduced the combined relative risk of CV death or hospitalization for heart failure by 25% compared with placebo in adults with HFrEF. The FDA is expected to make a decision on this indication later this year.
Empagliflozin is marketed under the trade name Jardiance, which is currently approved to reduce the risk of CV death in adults with type 2 diabetes and established CV disease. It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Breakthrough results for Jardiance® (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction. [press release]. Ridgefield, CT and Indianapolis, IN: Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company; July 6, 2021.