The FDA has approved dulaglutide as the first type 2 diabetes medication to reduce major adverse cardiovascular events (MACE) in adults with diabetes and established cardiovascular disease, according to a release from the manufacturer.

The approval came after the completion of the REWIND cardiovascular outcomes trial, which included patients with CV risk factors, but not necessarily CV disease. REWIND was a multicenter, randomized, double-blind, placebo-controlled trial where patients were prescribed a 1.5 mg dose or a placebo, which were added to standard of care. 

The primary outcome was first occurrence of MACE, defined as the composite of CV death or nonfatal myocardial infarction or nonfatal stroke. The secondary outcomes included “each component of the primary composite CV outcome,” as well as heart failure requiring hospitalization, and all-cause mortality, among others.  a composite clinical microvascular outcome comprising retinal or renal disease

The patient population included more than 9,000 people from 24 countries who had a mean duration of diabetes of 10.5 years, and a baseline A1C of 7.2%, according to the manufacturer. Of the more than 9,000 patients enrolled, only 31.5% had established CV disease. This included myocardial infarction, ischemic stroke, or angina, among other conditions. 

“Globally, over 415 million people have type 2 diabetes, which is itself a cardiovascular risk factor,” said Hertzel Gerstein, MD, MSc, FRCPC, professor of medicine and deputy director of the Population Health Institute at McMaster University and Health Sciences. “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.” 

Trulicity has been approved for use in the United States since 2014 for the treatment of type diabetes.