The drug also reduced the risk of myocardial infarction and stroke.
Elisabetta Patorno MD, DrPh
Findings of a recent study suggest empagliflozin is associated with a decreased risk of hospitalization for heart failure and a similar risk of myocardial infarction or stroke in routine clinical care.
The findings were presented as part of the American Diabetes Association’s (ADA’s) 80th Virtual Scientific Sessions.
In a previous trial, EMPA-REG OUTCOME, empagliflozin reduced the risk of cardiovascular death by 38%, all-cause mortality by 32%, and hospitalization for heart failure by 35% in patients with type 2 diabetes and established cardiovascular disease. The EMPRISE study aimed to assess comparative effectiveness, safety, healthcare utilization, and cost of empagliflozin in patients with type 2 diabetes.
Elisabetta Patorno, MD, DrPH, and a team of investigators used data from Medicare and 2 US commercial claims datasets. The team collected data on empagliflozin for 5 years from August 2014-September 2019. The objective of the study was to analyze the data over 3 years from 2014-2017 to assess selected effectiveness and safety outcomes within 39,169 pairs of 1:1 propensity score-matched patients >18 years old with type 2 diabetes initiating EMPA or a DPP-4 inhibitor (DPP-4i).
For effectiveness outcomes, the team was interested in hospitalizations for heart failure, defined as a heart failure discharge diagnosis in the primary (specific) or in any position (broad), a composite of myocardial infarction and stroke, and all-cause mortality (Medicare only). Safety outcomes included lower limb amputations, bone fractures, diabetic ketoacidosis, and acute kidney injury.
Of the more than 39,000 patients included in the study, the mean age for empagliflozin was 60.25 years old and 60.28 years old for the DPP-4i group. A majority of the patients were female in both groups (54% vs 54%). Slightly more patients had a history of cardiovascular disease in the empagliflozin group (28% vs 27.8%).
In a comparison with DPP-4i, EMPA had a reduced risk of hospitalizations for heart failure (specific, .46; .3-.73; broad, .63; .51-.77), a similar risk of myocardial infarction or stroke (HR, .89; 95% CI, .73-1.09), and a reduced risk of all-cause mortality (HR, .52; 95% CI, .36-.76) in Medicare. There was a mean follow-up of 178 days and EMPA was associated with a decreased risk of acute kidney injury (HR, .64; 95% CI, .53-.77), an increased risk of diabetic ketoacidosis (HR, 1.56; 95% CI, 1-2.44), and a similar risk of lower limb amputations and fractures.
“While the number of events in this early assessment are still small for some of the safety outcomes, the data observed in this study are consistent with the currently available information on the safety profile of empagliflozin,” Patorno and the investigators wrote.
In routine care, the effectiveness profile of empagliflozin was consistent with randomized controlled trial findings and safety outcomes similar to previously documented information.
The study, “Effectiveness and safety of empagliflozin in routine care patients: interim results from the EMPagliflozin comparative effectIveness and SafEty (EMPRISE) study,” was published as part of ADA 2020.