Lilly says its once-weekly diabetes drug Trulicity cut major adverse cardiovascular events (MACE) in patients taking part in the REWIND trial.
According to the firm, Trulicity (dulaglutide) is the first type II diabetes medicine to demonstrate superiority in the reduction of MACE events in a clinical trial that included a majority of participants who did not have established CV disease.
REWIND assessed the risk of MACE - a composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke - in adults with type II diabetes with a wide range of CV risk, comparing the effect of once-weekly Trulicity 1.5mg to placebo when added to standard of care.
Specific data are yet to be revealed, but Hertzel Gerstein, professor of medicine and deputy director of the Population Health Institute at McMaster University and Hamilton Health Sciences, and REWIND study chair, said the MACE reduction demonstrated by Trulicity in the study across a broad range of people with type II diabetes "is compelling."
"The broad range of people with type II diabetes studied in REWIND, including those with and without cardiovascular disease, underscores the importance of these findings in this precedent-setting trial," added Enrique Conterno, president, Lilly Diabetes and Lilly USA.
"Millions of people with type II diabetes face a high risk for cardiovascular disease. These data further validate Trulicity as a well-established option for people with type II diabetes."
Also of note, the safety profile of Trulicity in REWIND was generally consistent with the GLP-1 receptor agonist class, Lilly said.
Data from the trial will be submitted to regulatory authorities next year.