Trulicity? (dulaglutide) is the first and only type 2 diabetes medicine approved to reduce cardiovascular events in adults with and without established cardiovascular disease
[caption id="attachment_9277" align="aligncenter" width="1079"] Press Release[/caption]
New indication reflects distinct patient population in the REWIND study, including primarily people with multiple cardiovascular risk factors but without established cardiovascular disease
INDIANAPOLIS,?Feb. 21, 2020/PRNewswire/ --?The?U.S.?Food and Drug Administration (FDA) has approved Trulicity??(dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular (CV) disease or multiple cardiovascular risk factors. This decision makes?Eli Lilly and Company's?(NYSE: LLY) Trulicity the first and only type 2 diabetes medicine approved to reduce the risk of MACE for both primary and secondary prevention populations.*
The new indication reflects the differentiated patient population of REWIND, the Trulicity cardiovascular outcomes trial. While all participants had CV risk factors, the study consisted primarily of people without established CV disease. REWIND showed a significant risk reduction in MACE, a composite endpoint of nonfatal myocardial infarction (heart attack), nonfatal stroke or CV death. Results demonstrated consistent MACE risk reduction with Trulicity across major demographic and disease subgroups. Trulicity's safety profile was consistent with the GLP-1 receptor agonist (RA) class. The most common adverse events leading to the discontinuation of Trulicity were gastrointestinal events.
"The trial was designed to study a broad population of people living with type 2 diabetes, reflective of those in the general population. We therefore assessed the effect of Trulicity in people with established cardiovascular disease as well as those with multiple cardiovascular risk factors," 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 the REWIND study chair. "Globally, over 415 million people have type 2 diabetes, which is itself a cardiovascular risk factor. However, only about one third have established cardiovascular disease, which is why this new indication, and the supporting evidence, is important for the millions of people in the?U.S.?living with diabetes."
"For the first time, health care providers can prescribe a diabetes medicine proven to significantly reduce the risk of experiencing a cardiovascular event for people with type 2 diabetes with and without established cardiovascular disease," said?Sherry Martin M.D., vice president, medical affairs,?Lilly. "Trulicity can help people achieve their A1C goals and protect them from experiencing a cardiovascular event with a once-weekly, easy-to-use treatment option."
Trulicity has been available in the?U.S.?since 2014 and is the number one prescribed GLP-1 RA.?In addition to its proven glycemic efficacy and easy-to-use device**, Trulicity can now be prescribed to help people with type 2 diabetes reduce their risk of CV events.
About the REWIND Study
REWIND (Researching cardiovascular?Events with a?Weekly?INcretin in?Diabetes) 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. Prior (or established) cardiovascular disease in REWIND was defined as prior myocardial infarction, prior ischemic stroke, prior unstable angina, prior revascularization (coronary, carotid, or peripheral), prior hospitalization for ischemia-related events (unstable angina or myocardial ischemia on imaging, or need for percutaneous coronary intervention), or prior documented myocardial ischemia.
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.
PURPOSE AND SAFETY SUMMARY WITH WARNINGS
Important Facts About Trulicity? (Tr?-li-si-tee).? It is also known as dulaglutide.
TRULICITY is an injectable prescription medicine for adults with type 2 diabetes used to improve blood sugar (glucose) and used to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors.
- You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm. Use Trulicity together with the diet and exercise that your doctor recommends. Trulicity is not insulin.
- Do not use Trulicity if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity.
- Your healthcare provider should show you how to use Trulicity before you use it for the first time.
- Before?you?use?Trulicity,?talk?to?your?doctor?about?low?blood?sugar?and?how?to?manage?it.
- Do?you?have?other?medical?conditions,?including?problems?with?your?pancreas, kidneys,?liver,?or?stomach, or have a history of diabetic retinopathy?
- Do?you?take?other?diabetes?medicines, such as insulin or sulfonylureas?
- Do?you?take?any?other prescription?medicines?or?over-the-counter?drugs,?vitamins or?herbs?
- You are?pregnant or plan to become pregnant or breastfeeding or plan to breastfeed.
- You have type 1 diabetes or diabetic ketoacidosis.
- You?have or have hadan inflamed pancreas (pancreatitis).
- You have severe intestinal or stomach problems, such as slowed emptying or problems with digesting food.
- You?are a child?under?18 years old.
- Read the Instructions for Use that come with Trulicity.
- Use Trulicity exactly as your doctor says.
- Do not share your Trulicity pen, syringe or needles with another person.
- Do not give Trulicity to other people.
- If you take too much Trulicity, call your healthcare provider or seek medical advice promptly.
- Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017.?Atlanta, GA:?Centers for Disease Control and Prevention,?U.S. Dept of Health and Human Services; 2017.
- International Diabetes Federation.?IDF Diabetes Atlas,?9th edn.?Brussels, Belgium. Available at:?http://www.diabetesatlas.org.
Refer to: | Dani Barnhizer;?dbarnhizer@lilly.com; 317.607.6119 (Lilly Diabetes Communications) |
Kevin Hern;?hern_kevin_r@lilly.com; 317.277.1838 (Investor Relations) |
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SOURCE?Eli Lilly and Company