The EMPEROR-Preserved trial demonstrated safety and efficacy of empagliflozin for patients with heart failure across spectrum of ejection fraction.
The EMPEROR-Preserved Phase 3 trial met its primary endpoint, demonstrating empagliflozin (Jardiance) significantly reduced the risk of a composite of cardiovascular (CV) death or hospitalization for heart failure in adults with preserved ejection fraction (HFpEF).
The data was announced in a statement from Boehringer Ingelheim and Eli Lilly and Company.
With more than 60 million patients worldwide with heart failure, half of these patients have HFpEF, making it a prevalent public health issue and one of the largest unmet needs in CV medicine.
The EMPEROR-Preserved trial investigated empagliflozin 10 mg in comparison with placebo. Patients were randomized 1:1 to empagliflozin or placebo.
Primary endpoint included time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure with a follow-up of up to 38 months.
EMPEROR-Preserved was launched back in 2017 and, ultimately enrolled, 5988 patients with and without diabetes for inclusion in the phase 3 trial.
The results follow findings from the EMPEROR-Reduced Phase 2 trial, which show a significant reduction in combined relative risk of CV death or hospitalization for heart failure by 25% compared to placebo in adults with heart failure with HFrEF.
The results of the EMPEROR-Preserved are scheduled to be presented at the 2021 European Society of Cardiology meeting.
Professor Stefan Anker, heart failure cardiologist at Charité Berlin, Germany, and EMPEROR-Preserved principal investigator noted in a statement that HFpEF has been the most challenging form of heart failure to treat.
"Building on previous results from the EMPA-REG OUTCOME trial, and the EMPEROR-Reduced trial in heart failure with reduced ejection fraction, 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,” Anker said.
Jeff Emmick, MD, PhD, vice president, Product Development, Lilly, said in the statement that another important milestone has been reached with the SGLT2 inhibitor, citing previous reductions in CV death in patients with type 2 diabetes and cardiovascular disease (CVD).
“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," Emmick said.