Interim analysis from EMPRISE real-world study shows empagliflozin decreased risk of hospitalisation for heart failure compared with DPP-4 inhibitors and GLP-1 receptor agonists

  • This analysis on effectiveness also shows empagliflozin was associated with a similar risk of non-fatal atherosclerotic cardiovascular events compared with DPP-4 inhibitors or GLP-1 receptor agonists
  • A second analysis on healthcare resource utilisation shows empagliflozin was associated with a reduced risk in all-cause hospitalisations compared with DPP-4 inhibitors

A new interim analysis of three-year data from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world study on effectiveness shows that empagliflozin was associated with a decreased risk of hospitalisation 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 US with type  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, US.

“Heart failure is the most common cause of hospitalisation among individuals aged 65 years and over in Europe and the US. It is therefore encouraging to see that, in addition to the clinical trial setting, empagliflozin has been seen to reduce the risk of heart failure hospitalisation in people with type 2 diabetes in routine clinical practice,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “On top of this, as one in three people with type 2 diabetes has cardiovascular disease, it is encouraging to see similar results on risk of non-fatal atherosclerotic cardiovascular events with empagliflozin and other type 2 diabetes medications that have also previously shown favourable results for this endpoint.”

In this new interim analysis, empagliflozin was associated with a reduction in risk of hospitalisation for heart failure of 41 percent compared with DPP-4 inhibitors and of 17 percent compared with GLP-1 receptor agonists. Risk for non-fatal atherosclerotic cardiovascular events – defined as non-fatal heart attack or stroke, hospitalisation for unstable angina or coronary revascularisation – was similar for those treated with empagliflozin (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 empagliflozin (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, empagliflozin was associated with a significant reduction in all-cause hospitalisations, 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 empagliflozin showed a 35 percent relative risk reduction in hospitalisation 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 percent relative risk reduction in cardiovascular death in those taking empagliflozin 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, MD, Vice President, Global Medical Affairs, Lilly. “These new real-world findings are just one part of a broad and comprehensive clinical development programme, including a large heart failure programme, that explores how empagliflozin 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 programme. The programme, 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.

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