Treatment with the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) significantly reduces the risk of cardiovascular death or hospitalization for heart failure in adults with heart failure and preserved ejection fraction (HFpEF), according to top-line results of the EMPEROR-Preserved phase 3 study.
EMPEROR-Preserved investigated the safety and efficacy of empagliflozin 10 mg compared with placebo in 5988 patients with HFpEF with or without diabetes.
The primary endpoint was time to first event of adjudicated CV death or HF hospitalization over the course of up to 38 months.
Eli Lilly and Boehringer Ingelheim did not release any specific results other than saying the trial met its primary endpoint.
Full results of EMPEROR-Preserved are scheduled for presentation August 27 during the European Society of Cardiology (ESC) Congress 2021.
“HFpEF has long been the most challenging form of heart failure to treat,” principal investigator Stefan Anker, MD, PhD, Charité Berlin, Germany, said in a statement from the company announcing the top-line results today.
“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,” said Anker.
The results are in line with the EMPEROR-Reduced trial, which showed that empagliflozin significantly reduced the combined relative risk of CV death or HF hospitalization by 25% compared with placebo in adults with HF and reduced ejection fraction (HFrEF).
The EMPEROR-Reduced results formed the basis of the recent approval of a new indication for empagliflozin for the treatment of adults with HFrEF by the European Commission.
Empagliflozin is not approved for HF in the United States. Boehringer Ingelheim and Lilly have submitted a supplemental new drug application for empagliflozin to reduce the risk of CV death or HF hospitalization in adults with HFrEF to the US Food and Drug Administration, with a decision expected later this year.
The companies plan regulatory submissions for empagliflozin for HFpEF this year.
“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,” Mohamed Eid, MD, Boehringer Ingelheim vice president, clinical development & medical affairs, cardio-metabolism & respiratory medicine, said in the news 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 SGLT2 inhibitor to treat a defined population of adults with heart failure with either preserved or reduced ejection fraction,” Eid said.