Boehringer Ingelheim and Eli Lilly Release Full Phase III EMPERIAL Trial Data for Jardiance (Empagliflozin) in Heart Failure Patients

June 22, 2020 /BioonBIOON/ -- Boehringer Ingelheim -Eli LillyDiabetesThe Alliance recently announced the complete data from the Phase III EMPERIAL trial of Jardiance® (Chinese brand name: Oujing®; generic name: empagliflozin), an SGLT2 inhibitor for diabetes, in heart failure.This project includes two Phase III trialsClinical TrialEMPERIAL-Reduced and EMPERIAL-Preserved were conducted in adult patients with heart failure with reduced ejection fraction (HFrEF) and adult patients with heart failure with preserved ejection fraction (HFpEF), respectively.

Data from two trials showed that, based on the results of the 6-minute walk test (6MWT, the primary endpoint of the studies), there was no significant difference between Jardiance and placebo in the change in exercise capacity from baseline to week 12 of treatment. The specific data were as follows: (1) In the EMPERIAL-Reduced trial, the median increase in 6MWT distance was 18.0 meters in the placebo group and 13.5 meters in the Jardiance group. (2) In the EMPERIAL-Preserved trial, the median increase in 6MWT distance was 10.0 meters in the Jardiance group versus 5.0 meters in the placebo group.

In the EMPERIAL-Reduced trial, exploratory analyses suggested that Jardiance was associated with improvements in quality of life. In this trial, researchers employed the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used measure of quality of life in patients with heart failure. The mean improvement in the KCCQ Total Symptom Score (TSS) from baseline to Week 12 was 4.55 points greater in the Jardiance group than in the placebo group. Furthermore, a higher proportion of patients in the Jardiance group achieved improvements of at least 5 and 8 points in the KCCQ-TSS compared with the placebo group; these two prespecified thresholds were established to define clinically meaningful responses to treatment.However, in the EMPERIAL-Preserved trial, a similar exploratory analysis conducted in patients with heart failure with preserved ejection fraction (HFpEF) showed that Jardiance did not improve these same outcome measures compared with placebo.

These two trials includedDiabetesPatients and noneDiabetespatients. InDiabetesAmong patients, the safety profile of Jardiance was similar to that known in adult patients with type 2 diabetes. In patients without diabetes, no new safety events were identified, and the frequency of hypoglycemic events with Jardiance in this population was comparable to that with placebo. Overall, across these two trials, there were no significant differences between Jardiance and placebo in the frequency of adverse events (including those leading to discontinuation of the study drug), and no new safety concerns were identified.

It should be noted that therapeutic approaches recommended by other heart failure guidelines have demonstrated varying results in studies evaluating clinical outcomes and symptom improvement; while some studies showed improvements in outcomes such as mortality, they reported neutral or inconsistent findings regarding exercise capacity and patient-reported outcomes.

Eli LillyJeff Emmick, M.D., Vice President of Product Development, stated, “Cardiorenal-metabolic diseases are a group of conditions affecting the heart, kidneys, and endocrine system, and are becoming increasingly prevalent. Our EMPOWER”Clinical Trials“The program is exploring the impact of Jardiance across the entire cardiorenal-metabolic disease spectrum, representing one of the most extensive and comprehensive initiatives to evaluate an SGLT2 inhibitor. Through our research, we aim to generate new knowledge that helps improve clinical outcomes for millions of patients affected by these conditions.”

Jardiance was approved for marketing in August 2014 for the treatment of patients with type 2 diabetes. In late 2016, Jardiance received further approval to reduce the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease. This approval made Jardiance the first glucose-lowering drug worldwide approved to reduce the risk of cardiovascular death in patients with type 2 diabetes.

Jardiance is a blockbuster SGLT2 inhibitor antidiabetic drug, currently holding over 50% of the market share for SGLT2 inhibitors. In recent years,Eli Lilly- The Boehringer Ingelheim alliance has been committed to developing this drug for the treatment of heart failure and chronic kidney disease.

In China, Jardiance® (Ouyangjing®) was approved for marketing in September 2017. It is indicated as monotherapy or in combination with metformin, or with both metformin and sulfonylureas, to improve glycemic control in patients with type 2 diabetes. In November 2019, Jardiance® (Ouyangjing®) was officially included in the National Reimbursement Drug List (NRDL), which came into effect nationwide on January 1, 2020. With the nationwide implementation of the NRDL, it is believed that more Chinese patients with diabetes will benefit from this excellent therapeutic agent! (Bioon.com)

Original Source:Full results from EMPERIAL exercise ability trials presented