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 cardiovascular disease

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

September 22, 2020 09:29 ET | Source: Eli Lilly Canada

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.”

About the REWIND Study REWIND ( R esearching cardiovascular E vents with a W eekly IN cretin in D iabetes) 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 (according to local standard of care guidelines), 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 nonfatal myocardial infarction or nonfatal 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 10.5 years and a median baseline A1C of 7.2 percent. While all participants had CV risk factors, only 31.5 percent of the study participants had established CV disease while 62.8 percent only had multiple CV risk factors Prior (established) cardiovascular disease in REWIND was defined as a history of myocardial infarction, ischemic stroke, unstable angina, revascularization (coronary, carotid, or peripheral), myocardial ischemia by a stress test or cardiac imaging or hospitalization for unstable angina with at least one of the following: ECG changes, myocardial ischemia on imaging, or a need for percutaneous coronary intervention.

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.

About Diabetes in Canada Approximately 11 million Canadians live with diabetes or prediabetes. People with diabetes are over three times more likely to be hospitalized with cardiovascular disease and contribute to 30% of strokes and 40% of heart attacks. Diabetes can reduce lifespan by 5 to 15 years and complications are associated with premature death. It is estimated that the all-cause mortality rate among Canadians living with diabetes is twice as high as the all-cause mortality rate for people without diabetes. 1

About Lilly Diabetes Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and people who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more.

About Lilly Canada Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world’s first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca .

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Media Contact: Samira Rehman Rehman_Samira@lilly.com 647-617-1994

REFERENCES 1 www.diabetes.ca, Diabetes in Canada - Backgrounder, pg. 1, February 2020. *In a study, 94% of people said it was easy to use.