Empagliflozin, already indicated to improve outcomes in patients with HFrEF, reduced risk of a composite of CV death or hospitalization for HF in adults HFpEF, marking a potential therapeutic milestone.
Empagliflozin is the first sodium glucose cotransporter-2 inhibitor (SGLT2i) to demonstrate safety and efficacy in the treatment of patients with heart failure, regardless of ejection fraction.
The newest data come from the phase 3 randomized controlled EMPORER-Preserved trial which demonstrated as its primary endpoint that empagliflozin significantly reduced risk of a composite of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF), according to a statement from Boehringer Ingelheim and Eli Lilly and Company. The results were observed in study participants with and without type 2 diabetes.
The full results of EMPORER-Preserved are scheduled for presentation at the European Society of Cardiology Congress 2021, on August 27, 2021.
EMPORER-Preserved findings build on results of the earlier EMPORER-Reduced trial which showed that empagliflozin led to a significant reduction in the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% vs placebo in adults with heart failure with reduced ejection fraction (HFrEF). That trial served as the basis for a new indication for empagliflozin for treatment of HFrEF granted by the European Commission.
"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. HFpEF has long been the most challenging form of heart failure to treat," said Professor Stefan Anker, heart failure cardiologist at Charita Berlin, Germany, and EMPEROR-Preserved principal investigator, in the joint statement.
Anker says that, taken together, the results from the EMPA-REG OUTCOME, the EMPEROR-Reduced, and EMPEROR-Preserved trials demonstrate that empagliflozin “…has the potential to transform the care of people living with heart failure."
EMPEROR-Preserved was launched in 2017 and enrolled 5988 participants with HFpEF with or without diabetes. These patients were randomized 1:1 to empagliflozin 10 mg once daily or placebo. The trial’s primary endpoint was time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure over a follow-up period of up to 38 months.
"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, in the companies’ statement.
"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."
Empagliflozin in the EMPA-REG OUTCOME trial was the first SGLT2i shown to reduce the risk of cardiovascular death in people with T2D and CVD and was granted a label expansion by the US Food and Drug Administration (FDA). In the joint company statement, Jeff Emrick, MD, PhD, vice president, Product Development, Lilly, points to EMPORER-Preserved as reaching “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."
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.