Only 31 per cent of REWIND trial participants had established CV disease
TORONTO, Nov. 5, 2018 /CNW/ - 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 per cent, and only 31 per cent 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 multicentre, 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 per cent. Thirty-one per cent 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 revascularization (coronary, carotid, or peripheral), prior hospitalization for ischemia-related events (unstable angina, or need for percutaneous coronary intervention), or prior myocardial ischemia on imaging.
Indication and Limitations of Use for Trulicity®
TRULICITY is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with:
- diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance.
- metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control.
- metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control.
- basal insulin with metformin, when diet and exercise plus basal insulin with or without metformin do not achieve adequate glycemic control.
- prandial insulin with metformin, when diet and exercise plus basal or basal-bolus insulin therapy (up to two injections of basal or basal plus prandial insulin per day) with or without oral antihyperglycemic medications, do not achieve adequate glycemic control.
About Diabetes in Canada
Diabetes is a chronic disease that occurs when the body either cannot produce insulin or cannot properly use the insulin it produces.i Approximately 3.3 million Canadians have type 1 or type 2 diabetes and this number is expected to rise to 4.8 million by 2024.ii Diabetes can result in a variety of serious complications, including heart attack, stroke, kidney failure, blindness, problems with erection (impotence) and amputation.iii Metabolic control has demonstrated reduction in the risk of microvascular complications.iv
About Eli 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.
*Treatment effect of dulaglutide versus placebo for all randomized subjects while on treatment without use of rescue medication was assessed by Mixed Model for Repeated Measures (MMRM). The primary efficacy analysis was performed using a Bayesian dose-response model.
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i Canadian Diabetes Association. Types of Diabetes. http://www.diabetes.ca/about-diabetes/what-is-diabetes. Last accessed February 17, 2015.
ii Canadian Diabetes Association. Diabetes Charter for Canada, http://www.diabetes.ca/getmedia/6ba73187-45ec-43b8-a0e5-054ab6ce032a/diabetes-charter-backgrounder-alberta-english.pdf.aspx. Last accessed January 13, 2016.
iii Canadian Diabetes Association. Complications. http://www.diabetes.ca/diabetes-and-you/complications. Last accessed February 17, 2015.
iv Stratton IM, Adler AI, Neil HAW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ: British Medical Journal. 2000;321(7258):405-412. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC27454/. Last accessed January 26, 2016.
SOURCE Eli Lilly Canada Inc.
For further information: Media Contact: Ethan Pigott, Pigott_ethan@network.lilly.com, 416-770-5843