The FDA granted GLP-1 receptor agonist (GLP-1 RA) dulaglutide (Trulicity, Eli Lilly) an indication for the reduction of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) with established cardiovascular (CV) disease or with multiple CV risk factors.
Dulaglutide is the first T2D drug approved for both primary and secondary CV prevention, according to a press release from Eli Lilly.
"The trial was designed to study a broad population of people living with type 2 diabetes, reflective of those in the general population," said Hertzel Gerstein, MD, MSc, FRCPC, professor of medicine and deputy director of the Population Health Institute at McMaster University and Hamilton Health Sciences, and chair of the supporting REWIND study, in the press release. "We therefore assessed the effect of Trulicity in people with established cardiovascular disease as well as those with multiple cardiovascular risk factors."
The REWIND trial, on which the FDA based its label expansion, was a large, prospective, double-blind, randomized cardiovascular outcomes trial (CVOT) of dulaglutide vs placebo in 9901 adults aged at least 50 years with T2D. Participants were on stable doses of up to 2 oral antihyperglycemic agents, with or without basal insulin. Within the cohort, less than one-third (31.5%) had prior CVD, making REWIND the largest primary CVOT with a GLP-1 RA.
Trial results demonstrated that dulaglutide reduced the risk for MACE--a composite of nonfatal myorcardial infarction, nonfatal stroke, and CV death--by 12% vs placebo in T2D patients with and without CVD. Results demonstrated consistent MACE risk reduction with dulaglutide across major demographic and disease subgroups.
In addition to the large proportion of participants without established CVD, the Lilly press release notes that the international scope of REWIND (24 countries), the high proportion of women (46.3%), and inclusion of participants with lower mean baseline A1c suggest the results can be generalized to the typical T2D patient seen in general practice.
"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," said study chair Gerstein.
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