Sometimes a medicine approved for one thing shows promise in treating something else. In the best case scenario, the medication gets the green light for treating that other condition. That just happened with the medication Trulicity (dulaglutide), which is an injectable prescription medicine for adults with type 2 diabetes manufactured by Eli Lilly. The U.S. Food and Drug Administration (FDA) approved a new indication for Trulicity to reduce the risk of major cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular disease or have multiple cardiovascular risk factors. Trulicity therefore becomes the first and only type 2 diabetes medication to “reduce cardiovascular events in adults with and without established cardiovascular disease.”
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The FDA approval was based on the results of a trial called REWIND, which stands for Researching Cardiovascular Events with a Weekly Incretin in Diabetes (an incretin is a hormone that stimulates the secretion of insulin by the pancreas). REWIND was a randomized, double-blind study carried out at 371 sites in 24 countries. Nearly 10,000 men and women aged 50 and above with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned to weekly injections of either Trulicity or a placebo. The group was 46% female and the average age was 66.2. The duration of follow-up was 5.4 years.
The results showed that a once-weekly injection of Trulicity was better than a placebo (inactive treatment) in improving glycemic control and reducing cardiovascular events in patients who had type 2 diabetes and higher cardiovascular risk. The study also found Trulicity modestly reduced A1C (0.6%), weight (about 3 ½ pounds), and systolic blood pressure (1.7 mm Hg).
These were considered significant findings. As Matthew C. Riddle, M.D., one of the lead investigators in REWIND and professor of medicine at Oregon Health and Science University, put it, “Both healthcare providers and patients who are looking for ways to reduce cardiovascular risks while also lowering glucose levels, blood pressure and weight will welcome the findings of this trial.” According to Sherry Martin, MD, vice president of medical affairs at Lilly, “For the first time, healthcare 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. 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.”
Want to learn more about protecting your heart? Read “Fight Off Heart Disease With These Five Heart-Healthy Foods” and “Lower Your Risk of Heart Disease.”