Trulicity significantly reduced major cardiovascular events in REWIND trial for type 2 diabetes

Detailed results from REWIND, the Trulicity (dulaglutide) cardiovascular outcome trial, showed a significant 12 percent reduction in major cardiovascular events (MACE), a composite endpoint of non-fatal myocardial infarction (heart attack), 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 highly anticipated data for Eli Lilly and Company's once-weekly Trulicity were presented during a symposium today 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 (median 5.4 years) and consisted primarily of people without established CV disease. While all participants had CV risk factors, only 31 percent 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 (7.2 percent) and had a balanced ratio of women (46.3 percent) to men (53.7 percent). 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 (HR=0.88, 95% CI: 0.79-0.99) was consistent across subgroups, including: established cardiovascular disease: HR=0.87, 95% CI: 0.74-1.02; no established cardiovascular disease: HR=0.87, 95% CI: 0.74-1.02; baseline A1C greater than or equal to 7.2 percent: HR=0.86, 95% CI: 0.74-1.00; baseline A1C less than 7.2 percent: HR=0.90, 95% CI: 0.76-1.06; women: HR=0.85, 95% CI: 0.71-1.02; and men: HR=0.90, 95% CI: 0.79-1.04. All three components contributed to the significant reduction Trulicity provided in MACE 3, including CV death (HR=0.91, 95% CI: 0.78-1.06), non-fatal heart attack (HR=0.96, 95% CI: 0.79-1.16) and non-fatal stroke (HR=0.76, 95% CI: 0.61-0.95).

Trulicity further showed reductions in composite microvascular outcomes (HR=0.87, 95% CI: 0.79-0.95), characterized by fewer composite renal outcomes. Analysis of the renal outcomes suggests long-term Trulicity use was associated with reduced progression of renal disease in people with type 2 diabetes. 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 percent compared to placebo (A1C: -0.46 percent [Trulicity], +0.16 percent [placebo]; Weight: -2.95 kg [Trulicity], -1.49 kg [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.

See-"Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial"- Prof Hertzel C Gerstein, MD ,Prof Helen M Colhoun, MD,Prof Gilles R Dagenais, MD, et al. Published:June 09, 2019DOI:https://doi.org/10.1016/S0140-6736(19)31149-3.