Positive top-line results from EMPA-REG OUTCOME were announced. This is a long-term clinical trial investigating cardiovascular ( CV ) outcomes for Jardiance ( Empagliflozin ) in more than 7,000 adults with type 2 diabetes ( T2D ) at high risk for cardiovascular events.
EMPA-REG OUTCOME met its primary endpoint and demonstrated superiority of Jardiance, when added to standard of care, in cardiovascular risk reduction.
The primary endpoint was defined as time to first occurrence of either cardiovascular death, or non-fatal myocardial infarction or non-fatal stroke.
Jardiance is the only glucose-lowering agent to have demonstrated cardiovascular risk reduction in a dedicated cardiovascular outcomes trial.
Approximately 50% of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease. Reducing cardiovascular risk is an essential component of diabetes management.
The safety profile of Jardiance was consistent with previous studies.
EMPA-REG OUTCOME was a multicentre, randomised, double-blind, placebo-controlled trial that involved more than 7,000 individuals from 42 countries observed for a median duration of 3.1 years.
The study was designed to assess the effect of Empagliflozin ( 10mg or 25mg once daily ) added to standard of care compared with placebo added to standard of care on cardiovascular events in adults with type 2 diabetes at high risk of cardiovascular events and with less than optimised blood glucose control.
The study was designed to first test for non-inferiority and then for superiority.
Standard of care comprised glucose lowering agents and cardiovascular drugs ( including antihypertensive and lipid lowering agents ). ( Xagena )
Source: Boehringer Ingelheim, 2015