Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company have presented the results of the EMPA-REG OUTCOME trial of Jardiance (empagliflozin) in type 2 diabetes patients at high-risk for cardiovascular (CV) events.
Jardiance is a once-daily pill taken in the morning, used along with diet and exercise, to lower blood sugar (A1C) in adults with type 2 diabetes.
The drug showed a significant reduction in both CV risk and death in the long-term, multicentre, randomised, double-blind, placebo-controlled trial.
More than 7,000 patients from 42 countries with type 2 diabetes at high-risk for CV events participated in the study.
Jardiance significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14% when added to standard of care in patients with type 2 diabetes and a 38% reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
In addition, the drug treatment also showed a lower risk of all-cause mortality of 32% reduction and hospitalisation for heart failure of 35% reduction.
Boehringer Ingelheim Global vice-president medicine Dr Hans-Juergen Woerle said: "The Boehringer Ingelheim and Lilly Diabetes Alliance is very pleased to share the results of the EMPA-REG OUTCOME trial with the healthcare community.
"Cardiovascular disease is the number one cause of death in people with type 2 diabetes worldwide and reducing cardiovascular risk, including death, is an essential component of diabetes management."
The results were presented at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden, and published in the New England Journal of Medicine.
The primary endpoint was time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke.
In the study, standard of care comprised of glucose-lowering agents and cardiovascular drugs, including blood pressure and cholesterol-lowering medications.