Eli Lilly and Company reported that it’s drug, Trulicity® significantly reduced major adverse cardiovascular events, a composite endpoint of cardiovascular death, non-fatal heart attack or stroke, meeting the primary efficacy objective in the REWIND clinical trial.
The company’s once-weekly Trulicity is the first type 2 diabetes medicine to demonstrate superiority in the reduction of major adverse cardiovascular events in a clinical trial that included a majority of participants who did not have established CV disease.
The study involved mostly patients without established CV disease at baseline, a first for the GLP-1 receptor agonist class.
The trial assessed the risk of a major adverse cardiovascular event in adults with type 2 diabetes with a wide range of CV risk.
It compared the effect of once-weekly Trulicity 1.5 mg to placebo when added to standard of care.
“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,” said Dr. Hertzel Gerstein, professor of medicine and deputy director of the Population Health Institute at McMaster University and Hamilton Health Sciences, and REWIND study chair.
“The MACE reduction demonstrated by Trulicity, across a broad range of people with type 2 diabetes, is compelling and we look forward to analyzing and reporting all of the data,” he added.
According to a company, the REWIND trial is distinct compared to other CV outcome trials due to the limited number of people with established CV disease who participated, allowing Trulicity’s CV effect to be measured in a broad population of people with type 2 diabetes.
The REWIND trial 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 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,” said Enrique Conterno, president, Lilly Diabetes and Lilly USA in a press release.
“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,” he noted.
- Trulicity® (dulaglutide) demonstrates superiority in the reduction of cardiovascular events for a broad range of people with type 2 diabetes. Eli Lilly and Company. 2018, November 5. Retrieved: https://www.prnewswire.com/news-releases/trulicity-dulaglutide-demonstrates-superiority-in-reduction-of-cardiovascular-events-for-broad-range-of-people-with-type-2-diabetes-300743485.html