PT - JOURNAL ARTICLE AU - Regier, Emily E. AU - Venkat, Manu V. AU - Close, Kelly L. TI - More Than 7 Years of Hindsight: Revisiting the FDA’s 2008 Guidance on Cardiovascular Outcomes Trials for Type 2 Diabetes Medications AID - 10.2337/cd16-0005 DP - 2016 Oct 01 TA - Clinical Diabetes PG - 173--180 VI - 34 IP - 4 4099 - http://clinical.diabetesjournals.org/content/34/4/173.short 4100 - http://clinical.diabetesjournals.org/content/34/4/173.full SO - diaclin2016 Oct 01; 34 AB - IN BRIEF Concerns raised about the cardiovascular safety of type 2 diabetes medications such as rosiglitazone prompted the U.S. Food and Drug Administration to issue draft guidance in 2008 that, in practice, has required large cardiovascular outcomes trials (CVOTs) for all new type 2 diabetes therapies. After more than 7 years and six completed and published trials to date, this is an opportune time to consider whether these studies, as currently designed and conducted, accurately assess the long-term benefit/risk profile of new therapies and whether they represent an optimal use of limited health care resources. This article presents and contextualizes opinions on CVOTs from 10 thought leaders in diabetes. It is intended to inform an exploration of the costs, medical ethics, and effectiveness of using large-scale CVOTs to assess the safety of new diabetes therapies.