The EMPRISE study (Real World Evidence): empagliflozin is reducing number of hospitalizations for heart failure, even in patients without cardiovascular disease

Summary

EMPRISE (Empagliflozin Comparative Effectiveness and Safety) is an ongoing, extensive RWE (“real world evidence”) study launched in 2016, whose main goal is to establish whether the CV benefit of empagliflozin as observed in the study EMPA-REG OUTCOME will also be confirmed under the conditions of normal clinical practice. The study is based on patient data collected from US medical databases and compares the results relating to patients who started treatment with empagliflozin versus a DPP-4 inhibitor, sitagliptin. The first results of the planned interim analysis of the EMPRISE study not only confirmed the findings of the RCT CVOT of the study EMPA-REG OUTCOME on the reduction of hospitalizations for heart failure (HHF), but also showed that HHF-related benefit is also present in patients without previous cardiovascular disease (CVD) or without previous heart failure (HF), and thus treatment could also be beneficial in primary prevention of HF and should be preferred over DPP4i, especially in patients where the goal is to reduce the development of HF and its consequences. Although the results of RWE studies may be limited by possible residual variables, the consistent study design and extensive “propensity score matching” of EMPRISE minimized possible sources of “bias”, which supports credibility and reliability of the results of this study.

Keywords:

diabetes – empagliflozin – EMPRISE – heart failure – real world evidence