title: Should recent experiences with CVOTs for oral hypoglycemic drugs allow us to rethink the regulatory paradigm?
abstract: In response to a meta-analysis raising significant concerns over the cardiovascular safety of rosiglitazone, the US Food and Drug Administration (FDA) issued a draft guidance directing sponsors of novel diabetes drugs to address cardiovascular risk, including large outcomes trials. Regulatory experience supports that outcomes trials, absent a clear signal of risk, may add reassurance, but also have significant consequences. The FDA should finalize this guidance, taking into account the regulatory experience since 2008.
authors.affiliation: University of Virginia School of Medicine, Director of the Virginia Center for Translational and Regulatory Sciences, Charlottesville, Virginia, USA.
authors.forename: R J
authors.initials: RJ
authors.lastname: Meyer
mesh_terms: D000284:Administration, Oral; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000175:diagnosis; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000009:adverse effects; D013850:Thinking; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone