Boehringer Ingelheim and Lilly announced positive topline results from a phase 3 trial evaluating the efficacy and safety of empagliflozin (Jardiance®), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in reducing the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF).
The double-blind EMPEROR-Reduced trial included 3730 adults with HFrEF, with and without diabetes. Patients were randomized to receive either empagliflozin 10mg once daily or placebo in addition to standard of care for up to 38 months. Results demonstrated that empagliflozin met the primary composite end point achieving superiority to placebo in reducing the risk for CV death or hospitalization due to heart failure.
“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,” said 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.
The safety profile of empagliflozin was observed to be consistent with its known profile. Full trial results will be presented in a hot line session at the European Society of Cardiology (ESC) Congress 2020 on August 29, and regulatory submissions are planned in 2020.
Additionally, empagliflozin is being assessed in adults with heart failure with preserved ejection fraction in the phase 3 EMPEROR-Preserved trial with results expected in 2021.
Jardiance is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). It is also indicated to reduce the risk of CV death in adults with T2DM and established CV disease.
1. Jardiance® meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in phase III trial in adults with and without diabetes. https://www.prnewswire.com/news-releases/jardiance-meets-primary-endpoint-in-reducing-risk-of-cardiovascular-death-or-hospitalization-for-heart-failure-in-phase-iii-trial-in-adults-with-and-without-diabetes-301102692.html. Published July 30, 2020. Accessed July 30, 2020.