A new interim analysis of three-year data from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world study on effectiveness shows that Jardiance (empagliflozin) was associated with a decreased risk of hospitalization for heart failure and a similar risk of non-fatal atherosclerotic cardiovascular events compared with DPP-4 inhibitors and GLP-1 receptor agonists. The interim analysis included 190,000 adults in the U.S. with type 2 diabetes with and without cardiovascular disease. The results were shared today on behalf of Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) at the American Heart Association® Scientific Sessions 2019 in Philadelphia.
"Heart failure is a leading cause of hospitalizations in the U.S., with about one million admissions annually, yet treatment options that are available for people living with this debilitating disease are not adequate to improve the problem," 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. "Data showed that Jardiance reduced the risk of hospitalization for heart failure in adults with type 2 diabeteswith and without cardiovascular diseasein both routine clinical practice and in a clinical trial setting."
In this new interim analysis, Jardiance was associated with a reduction in risk of hospitalization for heart failure of 41% compared with DPP-4 inhibitors and of 17% compared with GLP-1 receptor agonists. Risk for non-fatal atherosclerotic cardiovascular events—defined as non-fatal heart attack or stroke, hospitalization for unstable angina or coronary revascularization—was similar for those treated with Jardiance (14.6 events per 1,000 patient-years) compared with DPP-4 inhibitors (17.6 events per 1,000 patient-years). The risk was also similar for those treated with Jardiance (14.2 events per 1,000 patient-years) compared with GLP-1 receptor agonists (14.8 events per 1,000 patient-years).
In a second interim analysis of EMPRISE, which included more than 45,000 patients, Jardiance was associated with a significant reduction in all-cause hospitalizations, emergency department visits and physician's office visits compared with DPP-4 inhibitors.
Results from the EMPRISE real-world study in routine clinical care complement data from the landmark EMPA-REG OUTCOME® trial, in which Jardiance showed a 35% relative risk reduction in hospitalization for heart failure compared with placebo in adults with type 2 diabetes and established cardiovascular disease. The EMPA-REG OUTCOME trial also showed a 38% relative risk reduction in cardiovascular death in those taking Jardiance versus placebo in the same population.
"We are pleased to see the three-year data for EMPRISE continues to complement findings from the EMPA-REG OUTCOME trial," said Sherry Martin, M.D., vice president, Global Medical Affairs, Lilly. "These new real-world findings are just one part of a broad and comprehensive clinical development program, including a large heart failure program, that explores how Jardiance can improve patient health outcomes and potentially fill treatment gaps for people with cardiorenal metabolic conditions."
The effects of empagliflozin on heart failure-related outcomes and functional capacity in people with heart failure are being evaluated in the empagliflozin heart failure program. The program, which includes more than 9,500 adults with heart failure, including those with and without diabetes, consists of the EMPEROR-Reduced, EMPEROR-Preserved, EMPERIAL-Reduced, EMPERIAL-Preserved, EMPULSE and EMPA-VISION studies.