INDIANAPOLIS, November 5, 2018 – 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 (NYSE: LLY) 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.
“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 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. “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.”
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 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. “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.”
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.
About the REWIND Study
REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes) was a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of Trulicity 1.5 mg, a weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA), compared to placebo, both added to standard of care, on cardiovascular (CV) events in adults with type 2 diabetes. The primary CV outcome was the first occurrence of MACE (the composite of CV death or non-fatal myocardial infarction or non-fatal stroke). Secondary outcomes include each component of the primary composite CV outcome, a composite clinical microvascular outcome comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality. The 9,901 participants from 24 countries had a mean duration of diabetes of 10 years and a mean baseline A1C of 7.3 percent. Thirty-one percent of participants had established CV disease at baseline. Prior (or established) cardiovascular disease in REWIND was defined as prior myocardial infarction, prior ischemic stroke, prior unstable angina, prior revascularization (coronary, carotid, or peripheral), prior hospitalization for ischemia-related events (unstable angina or myocardial ischemia on imaging, or need for percutaneous coronary intervention), or prior documented myocardial ischemia.
The REWIND trial's international scope, high proportion of women, high proportion of people without established cardiovascular disease and inclusion of participants with a lower mean baseline A1C suggest that the findings will be directly relevant to the typical type 2 diabetes patient seen in general practice throughout the world.
Indication and Limitations of Use for Trulicity®
Trulicity is a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. It should be used along with diet and exercise. Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas (pancreatitis). Trulicity should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe gastrointestinal (GI) disease. It is not a substitute for insulin. It has not been studied in children under 18 years of age.