Empagliflozin ( Jardiance ) has significantly reduced the risk of the combined endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke by 14% when added to standard of care, in patients with type 2 diabetes ( T2D ) at high risk of cardiovascular events. There was a 38% reduction in cardiovascular death, with no significant difference in the risk of non-fatal myocardial infarction or non-fatal stroke.
In addition, treatment with Empagliflozin resulted in a lower risk of all-cause mortality ( 32% reduction ) and hospitalization for heart failure ( 35% reduction ).
Life expectancy of people with T2D at high cardiovascular risk is, on average, decreased by up to twelve years with approximately 50% of deaths in people with T2D caused by cardiovascular disease.
The effect of Empagliflozin in this trial was observed on top of standard of care. This means the benefit was seen over and above other treatments patients were already receiving for diabetes and/or cardiovascular disease ( such as blood pressure and cholesterol lowering-medications ).
The overall safety profile of Empagliflozin was consistent with previous trials. The incidence of diabetic ketoacidosis was at or below 0.1% and similar across all treatment groups.
These data were presented at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden, and simultaneously published in the New England Journal of Medicine ( NEJM ).
EMPA-REG OUTCOME was a long-term, multicentre, randomised, double-blind, placebo-controlled trial that involved more than 7,000 patients from 42 countries with type 2 diabetes mellitus at high risk for cardiovascular events.
There were 772 primary outcome events in the EMPA-REG OUTCOME trial over a median observation period 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.
The primary endpoint was defined as time to first occurrence of either cardiovascular death, or non-fatal myocardial infarction or non-fatal stroke.
The study was designed to first test for non-inferiority and then for superiority.
Standard of care was comprised of glucose-lowering agents and cardiovascular drugs ( including blood pressure and cholesterol-lowering medications ).
Of the 7,020 treated patients, more than 97% completed the trial and vital status was available for more than 99% of these patients at study end.
Empagliflozin is an oral, once daily, highly selective sodium glucose co-transporter 2 ( SGLT2 ) inhibitor approved for use in adults with type 2 diabetes mellitus.
Empagliflozin works by blocking the reabsorption of glucose by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of beta-cell function and the insulin pathway.
Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis ( increased ketones in the blood or urine ). ( Xagena )
Source: Boehringer Ingelheim, 2015