title: Are we waiting too long for the cardiovascular outcome trials with the glucagon-like peptide-1 receptor agonists?
abstract: Several new medicines are in development for the treatment of type 2 diabetes, and cardiovascular outcome trials are the gold standard for these medicines. This editorial demonstrates that despite being available for over 10 years, there are no cardiovascular outcome studies for any of the glucagon-like peptide-1 receptor agonists, which demonstrate cardiovascular safety or benefit in subjects with high cardiovascular risk. The author argues that the FDA should be ensuring that clinical outcome studies for subjects with type 2 diabetes and high cardiovascular risk be undertaken in a timelier manner.
authors.affiliation: Queensland University of Technology, School of Biomedical Sciences, Gardens Point campus, Faculty of Health, Brisbane , GPO 2343, QLD 4002 , Australia +61 7 3138 2015 ; sheila.doggrell@qut.edu.au.
authors.forename: Sheila A
authors.initials: SA
authors.lastname: Doggrell
mesh_terms: D002318:Cardiovascular Diseases / Q000209:etiology; D002986:Clinical Trials as Topic / Q000379:methods; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D015195:Drug Design; D052216:Glucagon-Like Peptide 1 / Q000819:agonists*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D012306:Risk; D013997:Time Factors
chemical_list: D007004:Hypoglycemic Agents; D052216:Glucagon-Like Peptide 1
keywords: cardiovascular outcomes; cardiovascular safety; clinical trials; glucagon-like peptide-1 receptor agonists; type 2 diabetes