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 StudyREWIND (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.
Warnings
Trulicity may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. If you have a symptom, tell your doctor.
Ask your doctor how to recognize the serious side effects below and what to do if you think you have one:
Inflamed pancreas (pancreatitis). Stop using Trulicity and call your healthcare provider right away if you have severe pain in your stomach area (abdomen), with or without vomiting, that will not go away. You may feel the pain from your abdomen to your back.
Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Trulicity.
Low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include dizziness or light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability or mood changes.
Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms of a serious allergic reaction which may include: swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.
Acute kidney injury. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration). This may cause kidney problems to get worse.
Severe stomach problems. Trulicity may cause stomach problems, which could be severe.
Common side effects
The most common side effects of Trulicity include nausea, diarrhea, vomiting, abdominal pain and decreased appetite.
These are not all the possible side effects of Trulicity.
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Before using
Review these questions with your doctor:
Review the list below with your doctor. Trulicity may not be right for you if:
How to take
Learn more
For more information, call 1-844-TRU-INFO (1-844-878-4636) or go to http://www.TRULICITY.com.
This summary provides basic information about Trulicity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Trulicity and how to take it. Your doctor is the best person to help you decide if Trulicity is right for you.
Please see full Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, andMedication Guide.
Trulicity is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
DG CON BS FEB2020
About DiabetesApproximately 30 million Americans1 and an estimated 463 million adults worldwide have diabetes.2 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone.1 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.
About Lilly DiabetesLilly 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 those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes. We offer a wide range of therapies and a continued determination to provide real solutionsfrom medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
AboutEli Lilly and CompanyLilly 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 a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
*Primary prevention: Reducing the risk of atherosclerotic cardiovascular disease by preventing or managing risk factors. Secondary prevention: Reducing the risk of another event in people who have had a serious CV incident or procedure.
**In a study, 94% of people said it was easy to use.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Trulicity (dulaglutide) as a treatment for type 2 diabetes and for the reduction of cardiovascular events and its safety profile and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study findings to date, that Trulicity will receive additional regulatory approvals or that Trulicity will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
PP-DG-US-2722 02/2020 Lilly USA, LLC 2020. All rights reserved.
SOURCE Eli Lilly and Company
Read more from the original source:
Trulicity (dulaglutide) is the first and only type 2 diabetes medicine approved to reduce cardiovascular events in adults with and without established...
- Fresh health warning over common additive used in thousands of ultra-processed foods including mayo and bread - Daily Mail - April 25th, 2024
- Vertex jumps to TreeFrog to enhance production of Type 1 diabetes cell therapy candidates - FiercePharma - April 25th, 2024
- Spotting the warning signs of diabetes in your pets - CBC.ca - April 25th, 2024
- Lexington-Fayette County health department organizing weekend diabetes awareness expo - WEKU - April 25th, 2024
- Preventive effects of SGLT2 inhibitors on incident hypertension in patients with diabetes who do not have hypertension ... - Nature.com - April 25th, 2024
- Curbing the Price of Novel Diabetes and Obesity Medications - Yale School of Medicine - April 25th, 2024
- Stanford Health closing Livermore Diabetes and Bariatric Center - Pleasanton Weekly - April 25th, 2024
- The association of ALT to HDL-C ratio with type 2 diabetes in 5074 years old adults: a population-based study ... - Nature.com - April 25th, 2024
- VERTEX AND TREEFROG THERAPEUTICS ANNOUNCE LICENSING AGREEMENT AND COLLABORATION TO ... - PR Newswire - April 25th, 2024
- Understanding the Complexity of Hyperglycemic Emergencies: Exploring the Influence of the Type and Duration of ... - Cureus - April 25th, 2024
- What Every Parent Should Know About Raising a T1D Kid - Health Central - April 25th, 2024
- Healthy Living & Diabetes Awareness Fair 2024 - University of New Mexico - April 25th, 2024
- New findings on pancreatic anatomy may affect diabetes research and treatment - Medical Xpress - April 25th, 2024
- The role of yogurt in diabetes and obesity prevention - News-Medical.Net - April 25th, 2024
- How exercising outdoors can prevent depression and diabetes - inews - April 25th, 2024
- Heart of the Valley: Valley woman discusses how she improved her health following diabetes diagnosis - KRGV - April 25th, 2024
- The Right Amount of Sleep Could Help Prevent This Extremely Common Disease - Inverse - April 25th, 2024
- 'Bread and Butter': Societies Issue T2D Management Guidance - Medscape - April 25th, 2024
- She was fired after not endorsing Splenda-filled salads to people with diabetes. Why? - The Guardian - April 25th, 2024
- Glycemic index of diets: importance beyond diabetes control - The Hindu - April 25th, 2024
- 1 woman thought she was destined for diabetes. This 1 realization helped her lose 70 pounds - Yahoo! Voices - March 29th, 2024
- Franciscan Health offering diabetes education at local churches - The Times of Northwest Indiana - March 29th, 2024
- For diabetes patients, needle-free insulin injections are on the way - ScienceBlog.com - March 29th, 2024
- Las Vegas nonprofit hosting health workshop specifically aimed at local Latinos - KTNV 13 Action News Las Vegas - March 29th, 2024
- How Often Do You Really Need to Check Your Blood Sugar Levels? - WSJ - The Wall Street Journal - March 29th, 2024
- Unintended Effects of Caps on Insulin Out-of-Pocket Costs - Managed Healthcare Executive - March 29th, 2024
- Study: Pompe treatment Nexviazyme isn't linked to new or worsening... - Pompe Disease News - March 29th, 2024
- A Smoker With New-Onset Pain in Both Feet - Medscape Reference - March 29th, 2024
- Pre-diabetes leads to Type 2 diabetes; Here's how to prevent and reverse it - WXII12 Winston-Salem - March 29th, 2024
- 'From Interpretation to Action': Using CGM to Manage T2D - Medscape - March 29th, 2024
- March: diabetes-kidney | News and features - University of Bristol - March 29th, 2024
- Health centers attempt to prevent diabetes - WTVM - March 29th, 2024
- Beyond Meat Unveils New and Expanded Line of Beyond Crumbles, Now Certified by the American Heart ... - Yahoo Finance - March 29th, 2024
- Beyond Meat Launches Revamped Plant-Based Crumbles, Earning American Heart and Diabetes Association ... - vegconomist - the vegan business magazine - March 29th, 2024
- Ypsomed hands off insulin pen needle business to focus on smart pump, autoinjector development - Fierce Biotech - March 29th, 2024
- Take the online diabetes test that could help save your life - NBC Connecticut - March 29th, 2024
- Study evaluates the use of tirzepatide in overweight/obese adults with type 1 diabetes - News-Medical.Net - March 29th, 2024
- Risk prediction using genes and gut bacteria can improve early detection of diseases like type 2 diabetes - Medical Xpress - March 29th, 2024
- On a Healthy Vegan Diet, I've Healed My Liver, Reversed Type 2 Diabetes, and Lost 35 Pounds - Forks Over Knives - March 29th, 2024
- Study Links Diet, Diabetes, and Alzheimers - Neuroscience News - March 29th, 2024
- Novo Nordisk Isn't in The "Magnificent Seven," but Here's Why I Think It Should Be - Yahoo Finance - March 18th, 2024
- Doctor warns of strange telltale sign of diabetes which can appear on the legs - The Mirror - March 18th, 2024
- Unraveling the complexities of muscle repair in diabetes: A call for targeted research and therapies - News-Medical.Net - March 18th, 2024
- Popular diabetes and weight loss drugs often hard to get for people who need them - NBC News - March 18th, 2024
- Your Health Matters: The ABCs of diabetes - The Globe | News, weather, sports from Worthington, Minnesota - The Globe - March 18th, 2024
- The Link Between Pancreatic Cancer and Diabetes - Cedars-Sinai - March 18th, 2024
- Nikita Kuzmin diabetes: what was he holding in the CBB house? - Cosmopolitan UK - March 18th, 2024
- FDA Approves Rezdiffra, the First Drug for Diabetes-Related Liver Disease - diaTribe Foundation - March 18th, 2024
- He took up running rather than take diabetes medication. It worked - South China Morning Post - March 18th, 2024
- Can Eating Yogurt Really Reduce Your Risk of Diabetes? - Health.com - March 18th, 2024
- Even short periods of diabetes remission are linked to lower risk of heart attack and stroke - The BMJ - March 18th, 2024
- Kidney stone risk factors and how type 2 diabetes medication may help - WECT - March 18th, 2024
- 'Making the Invisible Visible': CGMs Offer Insights for T2D - Medscape - March 18th, 2024
- Novo Nordisk Discontinues Insulin Medication After Cutting Its Price - The American Prospect - March 18th, 2024
- Infographic: Where GLP-1s Work Now -- and What's Coming - Medscape - March 18th, 2024
- Intermountain Health Experts Say Education Key to Prevention of Type 2 Diabetes | PRUnderground - PR Underground - March 18th, 2024
- International body recommends more sensitive test to indicate risk of developing diabetes - The Hindu - March 18th, 2024
- The importance of knowing your A1C level - KSAT San Antonio - March 18th, 2024
- Tandem Diabetes Care's t:slim X2 Insulin Pump is the First Automated Insulin Delivery System to Integrate with ... - Business Wire - January 9th, 2024
- Diffuse Alveolar Hemorrhage Occurring Suddenly in a Diabetic Patient With Asthma Exacerbation - Cureus - January 9th, 2024
- Virginia Tech researchers find drugs used to treat Type 2 diabetes reduce alcohol cravings - WRIC ABC 8News - January 9th, 2024
- FDA looking into reports of hair loss, suicidal thoughts in people using popular drugs for diabetes and weight loss - CNN - January 9th, 2024
- Glycemic control and cardiovascular outcomes in patients with diabetes and coronary artery disease according to ... - Cardiovascular Diabetology - January 9th, 2024
- Insulin price cap: More Americans will now pay no more than $35 - USA TODAY - January 9th, 2024
- Eli Lilly cracks down on the use of weight loss drugs Mounjaro and Zepbound for cosmetic reasons instead of for diabetes and obesity - Fortune - January 9th, 2024
- No Increased Risk of Suicidal Ideation With GLP-1 Drugs - Medpage Today - January 9th, 2024
- Ask the Doctors | New research being conducted to treat diabetes - Eureka Times-Standard - January 9th, 2024
- Salivary Chloride Intracellular Channel 1 (CLIC1) as a Hub of Gene-Gene Interactome of Periodontitis With Diabetes ... - Cureus - January 9th, 2024
- Why Omada's CEO Thinks Amazon Selected His Startup as the 1st Partner for Its New Program - MedCity News - January 9th, 2024
- Researchers find drugs used to treat type 2 diabetes and obesity reduce alcohol cravings - Medical Xpress - January 9th, 2024
- Randomized open-label trial of semaglutide and dapagliflozin in patients with type 2 diabetes of different ... - Nature.com - January 9th, 2024
- CV Safety Profile of TheracosBio's BRENZAVVY (bexagliflozin) Confirmed in Research Published in Diabetes ... - Business Wire - January 9th, 2024
- 6 "Bad" Fruits You Should Be Eating When You Have Diabetes, According to Dietitians - EatingWell - January 9th, 2024
- Children of Women with Type 1 Diabetes Have Increased Heart Defect Risk - Inside Precision Medicine - January 9th, 2024
- Transforming Corporate Health: Fitterfly's Success in Tackling Diabetes and Weight Issues - Business Standard - January 9th, 2024
- Ozempic and weight loss | News and views - Diabetes UK - January 9th, 2024
- Drugs used to treat Type 2 diabetes reduce alcohol cravings - ScienceBlog.com - January 9th, 2024
- People taking Wegovy and Ozempic have lower risk of suicidal thoughts vs. older drugs, study finds - ABC News - January 9th, 2024
- For Those With Diabetes On Medicare Part D, Insulin Is $35...If Its Covered - Forbes - October 27th, 2023
- Biologist Douglas Melton: I was studying frogs until my son was diagnosed with diabetes then I started looking for a cure - EL PAS USA - October 27th, 2023