Trulicity (dulaglutide) is now indicated as an adjunct to diet, exercise, and standard of care therapy to reduce the risk of non-fatal stroke in adults with type 2 diabetes mellitus who have multiple cardiovascular risk factors or established cardiovascul

New indication reflects distinct patient population in the REWIND study – people with type 2 diabetes with multiple cardiovascular risks or established cardiovascular disease

TORONTO, Sept. 22, 2020 (GLOBE NEWSWIRE) -- On September 11, 2020, Health Canada approved Trulicity (dulaglutide) to reduce the risk of non-fatal stroke in adults with type 2 diabetes mellitus who have multiple cardiovascular risk factors or established cardiovascular disease, as an adjunct to diet, exercise, and standard of care therapy. This decision makes Eli Lilly and Company’s Trulicity the first and only GLP1 receptor agonist (RA) approved to provide a cardiovascular benefit in people with multiple CV risk factors or with established cardiovascular disease.

The new indication reflects the differentiated patient population of REWIND, the Trulicity cardiovascular outcomes trial. The study consisted primarily of people with multiple cardiovascular risk factors without established cardiovascular disease. REWIND showed a significant risk reduction in MACE-3, a composite endpoint of nonfatal myocardial infarction (heart attack), non-fatal stroke or CV death. Results demonstrated consistent MACE-3 risk reduction with Trulicity across major demographic subgroups. Trulicity's safety profile was consistent with the GLP-1 RA class. The most common adverse events leading to the discontinuation of Trulicity were gastrointestinal events.

“REWIND showed that the drug dulaglutide (marketed as Trulicity) reduced major cardiovascular events, including non-fatal stroke, in adults with type 2 diabetes who either had multiple cardiovascular risk factors or established cardiovascular disease,” says Dr. Hertzel Gerstein, Professor, and Deputy Director of the Population Health Research Institute at McMaster University and Hamilton Health Sciences, Hamilton, ON. “Trulicity’s new indication to reduce the risk of non-fatal stroke in these patients will provide physicians with an important tool for type 2 diabetes care.”

In addition to its proven glycemic efficacy and easy-to-use device*, Trulicity can now be prescribed to provide cardiovascular benefit to people with type 2 diabetes.

“The GLP-1 RA class represents an important advancement in the treatment of type 2 diabetes,” says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada. “The combination of Trulicity’s proven efficacy along with a new indication for non-fatal stroke represents a significant milestone in diabetes and cardiovascular management.”