Trulicity® (dulaglutide) demonstrates superiority in reduction of cardiovascular events in type 2 diabetics.
Trulicity® (dulaglutide) significantly reduced major adverse cardiovascular events (MACE), a composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke, meeting the primary efficacy objective in the precedent-setting REWIND trial.
Eli Lilly and Company’s once-weekly Trulicity is the first type 2 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.
The study included a majority of patients without established CV disease at baseline, a first for the GLP-1 receptor agonist class. REWIND assessed the risk of MACE in adults with type 2 diabetes with a wide range of CV risk. The study compared the effect of once-weekly Trulicity 1.5 mg to placebo when added to standard of care.
REWIND is distinct compared to other CV outcome trials due to the limited number of people with established CV disease who participated in the trial, allowing Trulicity’s CV effect to be measured in a broad population of people with type 2 diabetes. Importantly, REWIND had a median follow-up period of more than 5 years, the longest for a CV outcome trial in the GLP-1 receptor agonist class. In comparison, other CV outcome trials had more people with a higher baseline A1C and a greater percentage of patients who had established CV disease. Of the 9,901 REWIND participants, the mean baseline A1C was relatively lower at 7.3 percent, and only 31 percent had established CV disease.
The safety profile of Trulicity in REWIND was generally consistent with the GLP-1 receptor agonist class. Lilly plans to submit these data to regulatory authorities next year and to share detailed results at the American Diabetes Association Scientific Sessions in 2019.
Hertzel Gerstein, M.D., MSc, FRCPC, professor of medicine and deputy director of the Population Health Institute at McMaster University and Hamilton Health Sciences, and REWIND study chair said, “The REWIND study was ambitious, assessing whether Trulicity could protect people with type 2 diabetes from experiencing an initial cardiovascular event, and prevent future events in those who have established cardiovascular disease. The MACE reduction demonstrated by Trulicity, across a broad range of people with type 2 diabetes, is compelling and we look forward to analysing and reporting all of the data.”
Enrique Conterno, president, Lilly Diabetes and Lilly USA commented on the superiority in reduction of cardiovascular events in type 2 diabetics, “The broad range of people with type 2 diabetes studied in REWIND, including those with and without cardiovascular disease, underscores the importance of these findings in this precedent-setting trial. Millions of people with type 2 diabetes face a high risk for cardiovascular disease. These data further validate Trulicity as a well-established option for people with type 2 diabetes.”