Empagliflozin may not increase exercise ability in chronic heart failure: Phase III Trials

RIDGEFIELD, Conn. and INDIANAPOLIS -- The results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to functional endpoints with Jardiance® (empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively have been announced.

In both trials, there was no significant change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. The safety profile seen in the EMPERIAL trials was similar to the currently known safety profile of Jardiance and no new safety risks were identified.

EMPERIAL consisted of two Phase III randomized, double-blind trials in adults with or without diabetes. The trials evaluated the effect of 12 weeks' treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* The primary endpoint was measured by the six-minute walk test, a common measure of exercise ability.

The EMPERIAL trials, which included people with and without diabetes, deliver novel safety data for Jardiance in non-diabetic patients with heart failure. In addition, EMPERIAL-Preserved is the first trial to deliver safety data for Jardiance in heart failure with preserved ejection fraction.

"Our large heart failure clinical program underscores our dedication to researching new options for people living with this condition," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "The EMPERIAL trials set a high bar for Jardiance to demonstrate an improvement in exercise ability in people with chronic heart failure, and we continue to believe in its potential to improve clinical outcomes. The ongoing EMPEROR trials—which are investigating outcomes including cardiovascular death, hospitalization for heart failure and quality of life—remain the cornerstone of our heart failure program, and we look forward to sharing initial results in 2020."

The EMPERIAL trials used the six-minute walk test, which measures the distance a person can walk in six minutes, to evaluate changes in exercise ability over 12 weeks. For other heart failure guideline-recommended therapies, there have been divergent results between studies examining clinical outcomes and symptom improvement, with some showing improvements in outcomes such as mortality, but neutral or inconsistent results in exercise ability and patient-reported outcomes.

The ongoing empagliflozin heart failure program also includes the EMPEROR-Preserved, EMPEROR-Reduced, EMPULSE and EMPA-VISION studies. The program, which will include more than 10,000 adults, investigates the effects of empagliflozin on heart failure-related outcomes and patient-related outcomes in people with heart failure. The EMPERIAL studies were initiated based on data obtained from the EMPA-REG OUTCOME® trial, in which Jardiance showed a 38% relative risk reduction in cardiovascular death and a 35% relative risk reduction in hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease, compared to placebo.

"The EMPERIAL trials highlight our commitment to listening to patients' needs and studying the impact of our treatments on important measures such as quality of life," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. "Boehringer Ingelheim and Lilly will continue to explore how Jardiance can potentially improve health outcomes and fill treatment gaps for people with cardiorenal metabolic conditions, including adults with chronic heart failure."