EMPRISE is a study program on the effectiveness, safety and healthcare utilization of Empagliflozin ( Jardiance ), a SGLT2 inhibitor ( SGLT2i ), in routine care across a spectrum of cardiovascular baseline risk using real-world data from two U.S. commercial and Medicare claims datasets ( 2014-2019 ).
In an interim analysis ( 2014-2016 ), researchers have identified a 1:1 propensity score-matched cohort of patients 18 years or more with type 2 diabetes initiating Empagliflozin or a DPP4 inhibitor ( DPP4i ), and have compared the risk of hospitalization for heart failure or death from any cause, lower-limb amputations, bone fractures, and diabetic ketoacidosis.
After matching, 17,539 patient pairs with similar characteristics were identified.
Compared to DPP4i, Empagliflozin has decreased the risk of hospitalization for heart failure or death by 42% [ hazard ratio, HR = 0.58; ( 95% CI, 0.45-0.74 ) ], with an increased risk of diabetic ketoacidosis [ HR=2.16 ( 1.02-4.58 ) ], and no meaningful association with lower-limb amputations [ HR=1.12 ( 0.55-2.30 ) ] or fractures [ HR=0.63 ( 0.33-1.22 ) ].
Hospitalization for heart failure or death results were consistent in patients with and without cardiovascular disease.
In conclusion, an interim assessment from EMPRISE has shown that compared with DPP4i, Empagliflozin use in routine care was associated with a decreased risk of hospitalization for heart failure or death and with a neutral effect for lower-limb amputations and bone fractures, supporting the EMPA-REG OUTCOME results.
Diabetic ketoacidosis risk was elevated confirming the existing Empagliflozin labeling information. ( Xagena )
Patorno E et al, Journal of the American College of Cardiology 2019; Volume 73, Issue 9 Supplement 1