BI and Eli Lilly Announce Empagliflozin Meets Primary Endpoint in Phase III Trial for Heart Failure with Reduced Ejection Fraction

Today, Boehringer Ingelheim and Eli Lilly and Company jointly announced that empagliflozin (brand name Jardiance), an SGLT2 inhibitor co-developed by the two companies, met its primary endpoint in a Phase 3 clinical trial in adult patients with heart failure with reduced ejection fraction. Compared with placebo, the addition of empagliflozin (10 mg) to standard of care significantly reduced the composite risk of cardiovascular death or hospitalization due to heart failure.

Heart failure is a progressive, debilitating, and potentially fatal disease. It is a widespread condition affecting 60 million people worldwide, and the number of patients is expected to increase as the population ages. Heart failure is very common in patients with diabetes; however, approximately half of heart failure patients do not have diabetes. The risk of death in patients with heart failure increases with each hospitalization. Heart failure with reduced ejection fraction (HFrEF) occurs when the myocardium cannot contract effectively, resulting in less blood being pumped into the body compared to a heart with normal function.

Empagliflozin is a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor administered orally once daily. In patients with type 2 diabetes and elevated blood glucose levels, empagliflozin inhibits SGLT2, thereby preventing renal reabsorption of glucose and promoting its excretion in the urine. Additionally, empagliflozin inhibits sodium reabsorption, which increases urinary sodium excretion and reduces fluid overload in the vascular system. The empagliflozin-induced changes in the metabolism of glucose, sodium, and water may contribute to a reduction in cardiovascular mortality.

The EMPEROR-Reduced trial, a randomized, double-blind, Phase 3 clinical study, evaluated the efficacy and safety of empagliflozin in patients with heart failure with reduced ejection fraction (HFrEF), including those with and without type 2 diabetes. The primary endpoint was the time to cardiovascular death or first hospitalization for heart failure. Detailed results of the trial were scheduled to be presented on August 29 at the 2020 European Society of Cardiology (ESC) Congress. Meanwhile, empagliflozin is also being evaluated in the EMPEROR-Preserved Phase 3 clinical trial for the treatment of adult patients with heart failure with preserved ejection fraction.

Dr. Milton Packer of Baylor University Medical Center in the United States, principal investigator of the EMPEROR clinical program, stated, “Heart failure is a common yet highly serious chronic cardiovascular disease that causes substantial disability and threatens the lives of millions of people worldwide. The results of the EMPEROR-Reduced trial demonstrate that SGLT2 inhibitors have the potential to become a new standard of care for this condition, representing a meaningful addition to currently established therapies.”

Eli Lilly and Boehringer Ingelheim are expected to submit regulatory applications in 2020.

References:

[1] Empagliflozin meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in Phase III trial in adults with and without diabetes. Retrieved July 30, 2020, from https://www.businesswire.com/news/home/20200730005445/en

Flash | Boehringer Ingelheim/Eli Lilly’s empagliflozin meets Phase 3 clinical endpoints, significantly reducing the risk of cardiovascular death and heart failure hospitalization in patients with heart failure

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