FDA approves Dulaglutide for adults with T2D, with or withou
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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.

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.

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.”

Source: https://pxmd.co/XnSDY
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