Eli Lilly presents data from Trulicity cardiovascular outcome trial
Detailed results from REWIND, the Trulicity cardiovascular outcome trial, showed a significant 12% reduction in major cardiovascular events, a composite endpoint of non-fatal myocardial infarction, non-fatal stroke or CV death. REWIND data showed a consistent MACE 3 effect in people with and without established CV disease. The CV risk reduction was sustained throughout the trial's duration. The data for Eli Lilly once-weekly Trulicity were presented during a symposium at the American Diabetes Association's 79th Scientific Sessions and simultaneously published in The Lancet. REWIND is the longest cardiovascular outcome trial in the GLP-1 receptor agonist class and consisted primarily of people without established CV disease. While all participants had CV risk factors, only 31% of study participants had established CV disease. The study also had one of the lowest median baseline A1Cs of any diabetes CV outcome trial to date and had a balanced ratio of women to men. This patient population is more representative of people with type 2 diabetes typically seen in clinical practice. REWIND compared the effect of Trulicity 1.5 mg to placebo, both in addition to standard of care, on the risk of MACE 3 in 9,901 adults with type 2 diabetes. The risk reduction shown by Trulicity for the overall study was consistent across subgroups. In addition to the long-term follow-up assessing CV outcomes, REWIND provides additional evidence of Trulicity's efficacy in treating diabetes. Trulicity reduced A1C across the study from a median baseline of 7.2% compared to placebo. Trulicity's safety profile was consistent with the GLP-1 receptor agonist class. The most common adverse events leading to the discontinuation of Trulicity were gastrointestinal events. The REWIND results have been submitted to regulatory authorities in the U.S. and Europe for review.