Initial results from the real-world EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study showed that the SGLT2 inhibitor empagliflozin was associated with a 44% relative risk reduction in hospitalization for heart failure (HHF) compared with dipeptidyl peptidase-4 (DPP-4) inhibitors in routine clinical practice in the U.S.A..

These results support findings from the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients–Removing Excess Glucose (EMPA-REG OUTCOME) trial, which showed a 35% relative risk reduction in HHF (a secondary endpoint) with empagliflozin compared with placebo, when added to standard of care, in people with T2DM and established cardiovascular disease (CVD).

EMPRISE was initiated to complement the EMPA-REG OUTCOME trial results by providing data on the comparative effectiveness, safety, healthcare resource utilization and costs in routine clinical care compared with DPP-4 inhibitors in approximately 35,000 people with T2DM with and without CVD. The study will assess the first five years of empagliflozin use in the U.S. from 2014 to 2019. Over 200,000 people with T2DM from two commercial U.S. healthcare providers and Medicare are projected to be included by study completion. Further results from EMPRISE will be presented in 2019.

EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with T2DM and established CVD. The study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke.

The overall safety profile of empagliflozin in EMPRISE was consistent with that of previous trials. The EMPRISE analysis of data will be presented at the American Heart Association (AHA) Scientific Sessions 2018 in Chicago, IL, U.S.A..

Source: press release Eli Lilly, Nov 5, 2018