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EMPERIAL top-line results: Empagliflozin for HFpEF, HFrEF fails to improve exercise ability
Boehringer Ingelheim and Eli Lilly and Co. announced negative top-line results for its EMPERIAL-Reduced and EMPERIAL-Preserved trials, noting that the SGLT2 inhibitor empagliflozin did not meet the primary endpoint of improvements in exercise ability according to the 6-minute walk test from baseline to 12 weeks compared with placebo in patients with chronic HF with reduced and preserved ejection fraction.
The safety profile of empagliflozin (Jardiance) was similar in the EMPERIAL trials compared with what is currently known about the drug without finding new safety risks, according to a press release from the company.
“Our large heart failure clinical program underscores our dedication to researching new options for people living with this condition,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs at Boehringer Ingelheim Pharmaceuticals, said in the release. “The EMPERIAL trials set a high bar for Jardiance to demonstrate an improvement in exercise ability in people with chronic heart failure, and we continue to believe in its potential to improve clinical outcomes.”
The EMPERIAL trials helped determine safety data for patients with HF and without diabetes, in addition to safety data for patients with HFpEF, according to the release. The EMPERIAL trials were initiated based on results of the EMPA-REG Outcome trial. As Healio previously reported, empagliflozin, when combined with standard care, reduced the risk for CV death by 38% compared with placebo. Patients treated with empagliflozin also experienced a 32% reduction in all-cause mortality risk and a 35% reduction in risk for hospitalization for HF.
“The EMPERIAL trials highlight our commitment to listening to patients’ needs and studying the impact of our treatments on important measures such as quality of life,” Jeff Emmick, MD, PhD, vice president of product development at Lilly, said in the release. “Boehringer Ingelheim and Lilly will continue to explore how Jardiance can potentially improve health outcomes and fill treatment gaps for people with cardiorenal metabolic conditions including adults with chronic heart failure.”
Results of the EMPERIAL trials will be presented in 2020, according to the release.
Disclosures: Eid is an employee of Boehringer Ingelheim. Emmick is an employee of Lilly.