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Feature Articles

More Than 7 Years of Hindsight: Revisiting the FDA’s 2008 Guidance on Cardiovascular Outcomes Trials for Type 2 Diabetes Medications

  1. Emily E. Regier1,2,
  2. Manu V. Venkat1,2,3 and
  3. Kelly L. Close1,2
  1. 1Close Concerns, San Francisco, CA
  2. 2The diaTribe Foundation, San Francisco, CA
  3. 3University of California, San Francisco, CA
  1. Corresponding author: Emily E. Regier, emily.regier{at}closeconcerns.com
Clinical Diabetes 2016 Oct; 34(4): 173-180. https://doi.org/10.2337/cd16-0005
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Abstract

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safety of type 2 diabetes medications such as rosiglitazone prompted the U.S. Food and Drug Administration to issue draft guidance in 2008 that, in practice, has required large cardiovascular outcomes trials (CVOTs) for all new type 2 diabetes therapies.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.

  • © 2016 by the American Diabetes Association.

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0 for details.

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Clinical Diabetes: 34 (4)

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More Than 7 Years of Hindsight: Revisiting the FDA’s 2008 Guidance on Cardiovascular Outcomes Trials for Type 2 Diabetes Medications
Emily E. Regier, Manu V. Venkat, Kelly L. Close
Clinical Diabetes Oct 2016, 34 (4) 173-180; DOI: 10.2337/cd16-0005

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More Than 7 Years of Hindsight: Revisiting the FDA’s 2008 Guidance on Cardiovascular Outcomes Trials for Type 2 Diabetes Medications
Emily E. Regier, Manu V. Venkat, Kelly L. Close
Clinical Diabetes Oct 2016, 34 (4) 173-180; DOI: 10.2337/cd16-0005
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© 2021 by the American Diabetes Association. Clinical Diabetes Print ISSN: 0891-8929, Online ISSN: 1945-4953.