Boehringer Ingelheim and Eli Lilly have announced that data from a new post-hoc analysis of the EMPA-REG OUTCOME trial found that three-year treatment with Jardiance (empagliflozin) lowered the risk of total cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Jardiance is an oral, once-daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor.
According to the findings published in The Lancet Diabetes & Endocrinology journal, Jardiance lowered the risk of first plus recurrent cardiovascular events, including 3P-MACE, hospitalisation for heart failure, and all-cause hospitalisation over placebo.
3P-MACE is a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death.
The long-term multi-centre, randomised, double-blind, placebo-controlled trial was conducted on 7,000 patients from 42 countries.
It evaluated the effect of once daily dose of 10mg or 25mg Jardiance versus placebo, along with standard of care (SOC).
SOC included glucose-lowering agents and cardiovascular drugs, such as medication for hypertension and hypercholesteremia.
Time to first occurrence of cardiovascular death, non-fatal heart attack, or non-fatal stroke was considered as the trial’s primary endpoint.
Jardiance reduced the relative risk of 3P-MACE by 22%, hospitalisations for heart failure by 42%, and all-cause hospitalisations by 17% compared to placebo, data showed.
The drug also reduced the risk of fatal or non-fatal myocardial infarction and coronary heart disease events by 21% and 20%, respectively.
Boehringer Ingelheim corporate vice-president and CardioMetabolic Medicine head Waheed Jamal said: “These new findings add to previous evidence of the ability of empagliflozin to reduce cardiovascular and all-cause mortality, and in fact suggest additional positive effects of empagliflozin on hospitalisation and atherosclerosis-related outcomes in people with type 2 diabetes with established cardiovascular disease.”
In the trial, Jardiance showed a safety profile that was consistent with the previously observed ones.