Boehringer Ingelheim and Eli Lilly have reported positive findings from the post-hoc analysis of the EMPA-REG OUTCOME clinical trial of empagliflozin performed in adults with type 2 diabetes and established cardiovascular disease.
The trial was conducted to evaluate if cardiovascular benefits are based on the number of cardiovascular risk factor goals reached.
According to the analysis results, the drug led to a decrease in the risk of cardiovascular death, hospitalisation for heart failure and 3P-MACE, irrespective of the number of risk factor goals achieved.
Boehringer Ingelheim CardioMetabolic Medicine corporate vice-president and head Waheed Jamal said: “Reducing cardiovascular risk in people with type 2 diabetes can be challenging, particularly in those with uncontrolled cardiovascular risk factors, such as blood sugar levels and blood pressure.
“It is therefore encouraging to see these findings from the EMPA-REG OUTCOME trial in which empagliflozin was shown to improve cardiovascular outcomes in people with type 2 diabetes and cardiovascular disease, irrespective of whether cardiovascular risk factors were controlled.”
Empagliflozin is an oral, selective sodium-glucose cotransporter 2 (SGLT2) inhibitor intended for the treatment of type 2 diabetes. It is believed that the sugar, salt and water metabolism changes induced by the drug may be responsible for cardiovascular death reductions.
The long-term, multi-centre, randomised, double-blind, placebo-controlled EMPA-REG OUTCOME trial involved more than 7,000 patients across 42 countries.
It investigated 10mg and 25mg once-daily empagliflozin in combination with standard of care, compared to placebo plus standard of care consisting of glucose-lowering agents and cardiovascular drugs.
The primary endpoint of the study was time to the first occurrence of cardiovascular death, non-fatal heart attack, or non-fatal stroke.
A 38%, 35% and 14% reduction was observed in the risk of cardiovascular death, hospitalisation for heart failure and 3P-MACE, respectively, in patients treated with the drug combination.
The post-hoc analysis showed that cardiovascular benefits were independent of the number of risk factor goals achieved.