Boehringer Ingelheim and Eli Lilly have presented its result on EMPRISE real-world research for Jardiance, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor that treats type 2 diabetes mellitus, at the American Heart Association (AHA) Scientific Sessions 2018 in Chicago.
This is the first analysis of the EMPRISE study, participated in by about 35,000 people with type 2 diabetes collected between August 2014 and September 2016.
The study has shown that Jardiance reduces the relative risk of hospitalization for heart failure (HHF) by 44 percent compared to DPP-4 inhibitors in the actual clinical setting in the U.S.
These results correlate with the company’s previous EMPA-REG OUTCOME clinical trial, which indicated that empolyglobulin, when combined with standard therapies in patients with type 2 diabetes with cardiovascular disease, reduces the relative risk of hospitalization for heart failure versus placebo by 35 percent.
“With more than a million hospital admissions for heart failure in the U.S. every year, it’s important to understand whether the relative risk reduction in hospitalization for heart failure seen in the EMPA-REG OUTCOME® trial translates into routine clinical care,” said Professor Elisabetta Patorno of the Brigham and Women’s Hospital’s Division of Pharmacoepidemiology and Pharmacoeconomics and study co-investigator.
These first results from the EMPRISE study show that empagliflozin is associated with a reduction in hospitalization for heart failure, and the effect is consistent in people with type 2 diabetes with and without a history of cardiovascular diseases, she added.
The full EMPRISE real-world evidence study will provide a clinical picture of empagliflozin in routine clinical care including comparative effectiveness, safety and healthcare resource utilization and cost outcomes compared with commonly used DPP-4 inhibitors between 2014 and 2019.
Early findings from EMPRISE, which at completion will assess the first five years of empagliflozin use in the U.S., represent data collected between August 2014 and September 2016.
The company plans to update the results after collecting more data, while the safety data from EMPRISE are not yet available.
“Insights from the EMPRISE real-world evidence study are critical in today’s healthcare landscape to understand how gold standard clinical trials, such as the EMPA-REG OUTCOME® trial, can reduce the burden of cardiovascular disease in patients seen in everyday clinical practice,” said Waheed Jamal, Boehringer Ingelheim’s corporate vice president and head of CardioMetabolic Medicine.
Initial results from EMPRISE suggest that, compared with DPP-4 inhibitors, empagliflozin provides cardioprotective benefits in people with type 2 diabetes with and without cardiovascular disease, he added.
The company plans to conduct additional EMPRISE studies in Asia and Europe to provide insights from different regions of the world with an international perspective on the use of empagliflozin in routine clinical care from 2019.
Sherry Martin, Lilly’s vice president of medical affairs, also said, “The Boehringer Ingelheim and Lilly Diabetes Alliance is committed to building a comprehensive clinical picture of empagliflozin across the cardiovascular risk continuum in type 2 diabetes.”
She went on to say, “Physicians need better options to help their patients avoid hospitalization for heart failure, and we are encouraged that these findings from EMPRISE complement cardiovascular results from the EMPA-REG OUTCOME® trial.”
As part of their efforts to help address unmet needs, Boehringer Ingelheim and Lilly have initiated two large clinical trial programs focused on improving outcomes and reducing morbidity and mortality for people with heart failure.
EMPEROR HF comprises of two phase 3 outcome trials investigating empagliflozin for the treatment of adults with chronic heart failure, while EMPERIAL comprises of two phase 3 studies evaluating the effect of empagliflozin on exercise ability and heart failure symptoms in people with chronic heart failure with or without type 2 diabetes.