FDA grants dulaglutide CV indication for diabetes with or without established CVD
The FDA approved the GLP-1 receptor agonist dulaglutide for the reduction of major adverse cardiovascular events for adults with type 2 diabetes who have established cardiovascular disease or multiple CV risk factors, making it the first type 2 diabetes drug approved for primary and secondary prevention populations, according to a press release from Eli Lilly.
The new indication reflects findings from the REWIND trial, which demonstrated dulaglutide (Trulicity) reduced the risk for nonfatal myocardial infarction, nonfatal stroke and CV death by 12% compared with placebo among a large cohort of adults with type 2 diabetes with and without established CVD. The study, presented at the American Diabetes Association Scientific Sessions in June, was the first major CV outcomes trial for a diabetes therapy to include a large primary prevention population — within the cohort, only 31.5% of participants had prior CVD. REWIND was also the longest CV outcomes trial in the GLP-1 receptor agonist class (median follow-up time, 5.4 years) and had one of the lowest median baseline HbA1c levels of any diabetes CV outcome trial, according to Lilly.
“The trial was designed to study a broad population of people living with type 2 diabetes, reflective of those in the general population,” Hertzel Gerstein, MD, MSc, FRCPC, professor of medicine and deputy director of the Population Health Institute at McMaster University and Hamilton Health Sciences in Ontario, Canada, and the REWIND study chair, said in the release. “We therefore assessed the effect of Trulicity in people with established cardiovascular disease as well as those with multiple cardiovascular risk factors. 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.”
Results from REWIND demonstrated consistent major adverse CV risk reduction with dulaglutide across major demographic and disease subgroups. The most common adverse events leading to the discontinuation of dulaglutide were gastrointestinal events.
“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,” Sherry Martin, MD, vice president of medical affairs at Lilly, said in the release. “Trulicity can help people achieve their HbA1c goals and protect them from experiencing a cardiovascular event with a once-weekly, easy-to-use treatment option.”
As Healio previously reported, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended a label update in September for dulaglutide to reflect the positive REWIND findings and to include the medication’s CV benefits in the indication for use. – by Regina Schaffer
Disclosures: Eli Lilly funded the REWIND study. Gerstein reports he has received consultant fees, grants and honoraria from Abbott, AstraZeneca, Boehringer Ingelheim, Cirius, Eli Lilly, Janssen, Kowa, Merck, Novo Nordisk and Sanofi. Martin is vice president of medical affairs for Lilly.