EMPEROR-Reduced topline results: Empagliflozin beneficial in HFrEF with, without diabetes
Boehringer Ingelheim and Eli Lilly and Co. announced that the SGLT2 inhibitor empagliflozin to treat patients with HF with reduced ejection fraction, with and without diabetes, met its primary endpoint in the phase 3 EMPEROR-Reduced trial.
This trial demonstrated that 10 mg of empagliflozin (Jardiance) added to standard of care reduced the risk for a composite of CV death or HF hospitalization compared with placebo, according to a press release from the companies. The drug also demonstrated a similar safety profile as typically known with the drug.
“Heart failure is a common but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide,” Milton Packer, MD, distinguished scholar in cardiovascular science at Baylor University Medical Center in Dallas and chair of the executive committee for the EMPEROR program, said in the release. “The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments.”
This randomized trial assessed the safety and efficacy of empagliflozin in 3,730 patients with HFrEF.
“With these positive top-line results from the EMPEROR-Reduced trial, we are excited to mark another important advancement for Jardiance,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs within cardiometabolism and respiratory medicine at Boehringer Ingelheim, said in the release. “There is an urgent need for new heart failure treatments, and these results show promise for the potential role Jardiance can play in improving the lives of adults living with this condition.”
Results from the EMPEROR-Reduced trial will be presented during a hotline session at the European Society of Cardiology Congress on Aug. 29, according to the release. Regulatory submissions are also planned in 2020.
The EMPEROR-Preserved trial will assess the effects of empagliflozin related to CV death or hospitalization in patients with HF with preserved EF, with results expected in 2021.
“These results build upon the already established cardiovascular benefits of Jardiance in adults living with type 2 diabetes and cardiovascular disease,” Jeffrey Emmick, MD, PhD, vice president of product development for Eli Lilly and Co., said in the release. “Metabolic conditions that affect the heart and kidneys can lead to serious consequences including hospitalization and death. Through our EMPOWER clinical program, we are committed to advancing knowledge about these devastating outcomes.”