SESSION 1

Effectiveness and Safety of Empagliflozin in Routine Care: Results from the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) Study

The EMPA-REG OUTCOME trial showed that empagliflozin is superior to placebo in reducing the risk of cardiovascular death and hospitalization for heart failure in patients with type 2 diabetes (T2D) and established cardiovascular disease. These trial results lead to the expansion of empagliflozin's indication to reduce the risk of cardiovascular death in adult patients with T2D and cardiovascular disease and led to changes in major clinical guidelines.¹

However, the beneficial effects seen in the EMPA-REG OUTCOME trial had to be evaluated in routine clinical care, including in patients across a broader spectrum of cardiovascular risk.²

The EMPRISE study evaluated the effectiveness of empagliflozin in patients with T2D as treated in routine care

The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study evaluated the effectiveness, safety, and healthcare utilization of empagliflozin in routine care, utilizing real‐world data from two commercial and one federal US data sources across 5 years from 2014 to 2019 in patients with T2D across the spectrum of CV disease.²

The present final year 5 analysis of the EMPRISE study included 230,232 patients ≥18 years with type 2 diabetes initiating empagliflozin or a dipeptidyl peptidase-4 inhibitor (DPP-4i). The participants were followed-up for heart failure hospitalization in primary (HHF-Specific) or any discharge positions (HHF-Broad), a composite of myocardial infarction and stroke, and all-cause mortality (Medicare only).²

Safety outcomes included lower-limb amputations, non-vertebral fractures, diabetic ketoacidosis, acute kidney injury, renal and bladder cancers.²

The study results complement data from previous randomized control trials

67% of patients did not have cardiovascular disease at baseline. Compared to DPP4i, empagliflozin was associated with a 29-50% reduced risk of HHF [HHF-Specific: HR 0.50 (95% CI 0.44, 0.56); HHF-Broad: HR 0.71 (95% CI 0.67, 0.75)], a 12% reduced risk of the composite of myocardial infarction or stroke [HR 0.88 (95% CI 0.81, 0.96)], and a 40% reduction in all-cause mortality [HR 0.60 (95% CI 0.53, 0.68)] in a subset of patients aged >=65 years.² Results were consistent in patients with and without a history of cardiovascular disease.

Further, empagliflozin was associated with a reduced risk of acute kidney injury and a similar risk of lower-limb amputations, fractures, and renal and bladder cancer. There was an increased risk of diabetic ketoacidosis with empagliflozin, but this was consistent with the documented safety information.²

The study results from the present analysis complement data from previous randomized control trials and reiterates the beneficial effects of empagliflozin on cardiovascular outcomes, regardless of the baseline history of cardiovascular diseases.²