Positive Top-line Results for Another SGLT2 Inhibitor in HF

Megan Brooks

July 30, 2020

Top-line results of the EMPEROR-Reduced trial released today show that treatment with 10 mg empagliflozin, added to standard care, significantly reduced the risk for cardiovascular (CV) death or heart failure hospitalization in patients with heart failure with reduced ejection fraction (HFrEF), with and without diabetes.

Eli Lilly and Boehringer Ingelheim, supporters of the trial, did not release any specific results other than saying the trial met its primary endpoint.

Full results from the phase 3 trial will be reported in a hotline session August 29 during the virtual European Society of Cardiology (ESC) 2020 Congress. Regulatory submissions are planned in 2020.

Empagliflozin (Jardiance) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to treat type 2 diabetes.

In last year’s pivotal DAPA HF trial, another SGLT2 inhibitor, dapagliflozin (Farxiga), showed substantial benefit in reducing CV death and hospitalization in patients with HFrEF, with and without diabetes, suggesting a possible class effect.

The US Food and Drug Administration (FDA) approved dapagliflozin for HFrEF in May 2020.

"The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care" for HF, which will be a "meaningful addition to currently established treatments," 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 company press release.

In EMPEROR-Reduced, the overall the safety profile of empagliflozin was similar to the known safety profile of the drug.

EMPEROR-Reduced is a randomized, placebo-controlled trial investigating the safety and efficacy of empagliflozin in 3730 patients with HFrEF, with or without diabetes. The primary endpoint is time to first event of adjudicated CV death or adjudicated hospitalization for HF.

A second trial, EMPEROR-Preserved, is exploring the effect of empagliflozin on cardiovascular death or hospitalization in approximately 6000 adults with heart failure with preserved ejection fraction, with the same primary endpoint as EMPEROR-Reduced. Its results are expected next year.

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