Empagliflozin Trial Shows Positive Results for Reducing Risk of Cardiovascular Death or Hospitalization

Results of a phase 3 trial showed empagliflozin (Jardiance^®) 10 mg as superior in comparison to placebo in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure, when added to standard of care.

Positive top-line results of the EMPEROR-Reduced trial showed it meeting its primary endpoint, the time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure, according to Boehringer Ingelheim and Eli Lilly and Company. Completed this year, the trial enrolled 3730 patients.

The trial is part of the EMPOWER clinical program exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.

“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,” 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, in a prepared 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.”

Heart failure is the leading cause of hospitalization in the United States, and the risk of death in people with heart failure rises with each hospital admission. Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart. Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.

“There is an urgent need for new heart failure treatments, and these results show promise for the potential role [empagliflozin] can play in improving the lives of adults living with this condition,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, in a prepared statement.

Full results from the EMPEROR-Reduced trial will be presented during the European Society of Cardiology Congress on August 29, 2020.

A second trial, EMPEROR-Preserved, is exploring the effect of empagliflozin on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction—an area with no approved treatment options. EMPEROR-Preserved results are expected in 2021.

REFERENCE

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 [news release]. Ridgefield, CT, and Indianapolis, IN; July 30, 2020: Boehringer Ingelheim. [email] Accessed August 5, 2020.