Therapy Areas: Diabetes
Boehringer Ingelheim, Eli Lilly Tout Full Results of Phase III Trial of Empagliflozin
1 September 2020 - - Full results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, showed that empagliflozin was associated with a significant 25% relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalisation due to heart failure, Germany-based Boehringer Ingelheim and US-based Eli Lilly and Company (NYSE: LLY) said.

The trial evaluated the effect of adding empagliflozin (10 mg) versus placebo to standard of care.

The results will be presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, and published in The New England Journal of Medicine, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY).

The findings from the primary endpoint were consistent in subgroups with and without type 2 diabetes.1 Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30%.

Additionally, the rate of decline in eGFR, a measure of kidney function decline, was slower with empagliflozin than with placebo.

In an exploratory analysis, the absolute risk reduction observed in the primary endpoint of EMPEROR-Reduced corresponded to a number needed to treat of 19 patients over 16 months to prevent one cardiovascular death or hospitalization for heart failure.

An additional exploratory analysis showed that empagliflozin decreased the relative risk of a composite kidney endpoint*, including end stage kidney disease and a profound loss of kidney function, by 50%.

In EMPEROR-Reduced, the efficacy results were achieved with a simple dosing regimen, with once daily dosing and no need for titration.1 The safety profile was similar to the well-established safety profile of empagliflozin.

There were no clinically meaningful differences in adverse events including hypovolemia (decreased blood volume), hypotension (low blood pressure), volume depletion (loss of fluids), renal insufficiency (poor kidney function), hyperkalemia (high potassium levels) or hypoglycemic events (low blood sugar) compared with placebo.

Heart failure affects over 60m people worldwide, with more than one m people being hospitalized due to the condition every year in the US and Europe.

Heart failure occurs when the heart cannot pump sufficient blood to the rest of the body and is the most common and severe complication of a heart attack.

People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.

Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.

The US Food and Drug Administration has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with heart failure.

This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials. EMPEROR-Preserved is exploring the effect of empagliflozin on cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction, an area that currently has no approved treatment options.
Login
Username:

Password: