Lixisenatide and Cardiovascular Outcomes: The Burden of Proof

After cardiovascular (CV) safety concerns emerged with rosiglitazone use, the Food and Drug Administration (FDA) now requires outcome studies to be performed for all new diabetes medications.   The first CV safety study (ELIXA) for a drug in the glucagon-like peptide 1-receptor agonist (GLP-1 RA) class – lixisenatide - was published in December 2015.  Lixisenatide is a once-daily injectable GLP-1 RA approved for use in Europe and awaits FDA approval in the United States.