Empagliflozin Reduces Heart Failure Hospitalization, Death Risk in Phase 3 Trial

Empagliflozin (Jardiance; Eli Lilly and Boehringer Ingelheim) reduced the risk of cardiovascular death or hospitalization for heart failure (HF) in adults with and without diabetes, according to new top-line results from a phase 3 trial.

The EMPEROR-Reduced phase 3 clinical study met its primary end point, demonstrating superiority with empagliflozin over placebo in this setting, when added to standard of care, according to Eli Lilly. Overall, the safety profile was similar to the known safety profile of empagliflozin.

The EMPEROR HF studies include 2 phase 3, randomized, double-blind trials evaluating once-daily empagliflozin compared with placebo in adults with HF with preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care. This study, EMPEROR-Reduced, investigated the safety and efficacy of empagliflozin in 3730 patients with HF with reduced ejection fraction.

Full results from the EMPEROR-Reduced trial will be presented at the European Society of Cardiology Congress 2020 on August 29, and regulatory submissions are plannined in 2020, according to Eli Lilly.

“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, chair of the executive committee for the EMPEROR Program and distinguished scholar in cardiovascular science at Baylor University Medical Center in Dallas, Texas, said in a statement. “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.”

The EMPEROR-Preserved study, which is part of the EMPEROR program, will investigate the safety and efficacy of empagliflozin in patients with HF with preserved ejection fraction in an anticipated 5990 patients. The study is estimated to be completed in 2021.

Reference

Jardiance meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in phase 3 trial in adults with and without diabetes. News Release. Eli Lilly; July 30, 2020. Accessed July 31, 2020. https://investor.lilly.com/news-releases/news-release-details/jardiancer-meets-primary-endpoint-reducing-risk-cardiovascular