Eli Lilly and Boehringer Ingelheim’s Jardiance Meets Endpoints in EMPEROR-Preserved Trial in HFpEF Patients

July 6, 2021—Eli Lilly and Company, with Boehringer Ingelheim, announced that the EMPEROR-Preserved phase 3 trial met its primary endpoint, establishing Jardiance (empagliflozin) as a therapy to significantly reduce the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF).

Full results from the EMPEROR-Preserved trial, which investigated Jardiance 10 mg compared with placebo, are scheduled for presentation on August 27 at ESC 2021, the European Society of Cardiology Congress. Boehringer Ingelheim and Eli Lilly plan for regulatory submissions in 2021.

According to Eli Lilly, these findings, when added to the EMPEROR-Reduced phase 3 trial results, demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction. Additionally, the safety profile was generally consistent with the known safety profile of Jardiance. Together, these studies demonstrate the benefits of Jardiance for patients across the full heart failure spectrum, including HF with reduced EF (HFrEF) and HFpEF.

EMPEROR-Preserved investigated the safety and efficacy of Jardiance in patients with chronic HFpEF. The primary endpoint is time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure with the timeframe of up to 38 months. The trial, completed in 2021, enrolled 5,988 patients.

EMPEROR-Reduced investigated the safety and efficacy of Jardiance in patients with chronic HFrEF. The primary endpoint is time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure. The trial, which was completed in 2020, enrolled 3,730 patients. EMPEROR-Reduced showed that Jardiance significantly reduced the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% compared to placebo in adults with HFrEF.

Professor Stefan Anker, MD, who is a heart failure cardiologist at Charité—Universitätsmedizin Berlin in Berlin, Germany, serves as EMPEROR-Preserved principal investigator. “We look forward to presenting the EMPEROR-Preserved results at ESC 2021, which should offer a significant breakthrough in cardiovascular medicine and a new hope for people with HFpEF, which is an increasingly prevalent public health issue,” commented Prof. Anker in the companies’ announcement.

“HFpEF has long been the most challenging form of heart failure to treat,” Prof. Anker continued. “Building on previous results from the EMPA-REG OUTCOME trial, and the EMPEROR-Reduced trial in [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.”

In the press release, representatives for the companies discussed the significance of the trial findings.

Mohamed Eid, MD, Vice President, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc., stated, “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. 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.”

Jeff Emmick, MD, Vice President, Product Development, Lilly, added, “Jardiance was the first SGLT2 inhibitor to reduce cardiovascular death for people with type 2 diabetes and cardiovascular disease, and we have now reached another important milestone, this time in heart failure. The EMPEROR-Preserved results offer promise in a type of heart failure that until now has traditionally been very challenging to treat effectively. The EMPEROR heart failure studies are part of our EMPOWER clinical trial program exploring the effect of Jardiance across a spectrum of cardio-renal-metabolic diseases, aiming to significantly improve outcomes in these highly prevalent conditions that impact many people’s lives.”

The companies noted that the EMPEROR-Reduced results formed the basis of the recent approval of a new indication for Jardiance for the treatment of adults with HFrEF by the European Commission.

In the United States, Jardiance is not approved for the treatment of heart failure. A supplemental New Drug Application for Jardiance to reduce the risk of cardiovascular death or hospitalization for heart failure in adults with HFrEF has been submitted to the FDA, with a decision expected later this year.

Investigations are ongoing regarding Jardiance’s effects on hospitalization for heart failure and mortality in post-myocardial infarction patients with a high risk of heart failure. Jardiance is also currently being investigated in chronic kidney disease, advise the companies.