Empagliflozin, a sodium-glucose co-transporter 2 inhibitor manufactured by Boehringer Ingelheim and Eli Lilly, was not found to preserve the exercise ability of patients with chronic heart failure with reduced or preserved ejection fraction after 12 weeks of treatment when compared with placebo, according to the results of 2 phase 3 trials released by the company on December 13, 2019.
Empagliflozin is currently prescribed to adults with type 2 diabetes to lower the risk for cardiovascular death in those with a diagnosed cardiovascular condition, and to reduce blood sugar levels, in combination with a healthy diet and exercise.
The phase 3 randomized, double-blind, placebo-controlled EMPERIAL trials (EMPERIAL-preserved and EMPERIAL-reduced, Clinicaltrials.gov identifiers: NCT03448406 and NCT03448419, respectively) were designed to evaluate the effects of 10 mg of daily empagliflozin treatment for 12 weeks on the ability to exercise and heart failure symptoms in adult patients with chronic heart failure with preserved ejection fraction (n=315) or reduced ejection fraction (n=312). The 6-minute walk test was used to evaluate exercise ability at 12 weeks after treatment initiation (ie, distance walked during a 6-minute period).
Empagliflozin when compared with placebo, was not associated with changes in exercise ability from baseline to 12 weeks of treatment. No new safety risks associated with the drug were reported.
In a previous trial (EMPA-REG OUTCOME; Clinicaltrials.gov identifier: NCT01131676), empagliflozin was found to be associated with a relative risk reduction compared with placebo, of 38% and 35% for cardiovascular death and hospitalization for heart failure, respectively, in a cohort of 7064 patients with cardiovascular disease and type 2 diabetes, results which prompted the current EMPERIAL trials.
“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,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs at Boehringer Ingelheim Pharmaceuticals, Inc.
The failure of other recommended heart failure therapies to consistently improve both clinical outcomes (eg, mortality) and symptoms (eg, exercise ability) is outlined in the press release.
Press release. Boehringer Ingelheim and Lilly provide update on Jardiance® phase III exercise ability studies in chronic heart failure. Available at: https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-and-lilly-provide-update-jardiance-phase-iii-exercise-ability. Accessed December 13, 2019.