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Diabetes Care. 2018 Jan;41(1):14-31. doi: 10.2337/dci17-0057.

Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum.

Author information

1
American Diabetes Association, Arlington, VA wcefalu@diabetes.org.
2
Cedars-Sinai Medical Center, Los Angeles, CA.
3
McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
4
Diabetes Trial Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K.
5
Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
6
Diabetes Research Institute, University of Miami Leonard M. Miller School of Medicine, Miami, FL.
7
Duke University Medical Center, Durham, NC.
8
University of North Carolina School of Medicine, Chapel Hill, NC.
9
Yale School of Medicine and Yale New Haven Hospital, New Haven, CT.
10
Keenan Research Centre for Biomedical Science, Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Departments of Medicine and Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.
11
Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.
12
Dallas Diabetes Research Center at Medical City and The University of Texas Southwestern Medical Center, Dallas, TX.
13
Oregon Health & Science University, Portland, OR.

Abstract

In December 2008, the U.S. Food and Drug Administration issued guidance to the pharmaceutical industry setting new expectations for the development of antidiabetes drugs for type 2 diabetes. This guidance expanded the scope and cost of research necessary for approval of such drugs by mandating long-term cardiovascular outcomes trials (CVOTs) for safety. Since 2008, 9 CVOTs have been reported, 13 are under way, and 4 have been terminated. Reassuringly, each of the completed trials demonstrated the noninferiority of their respective drugs to placebo for their primary cardiovascular (CV) composite end point. Notably, four additionally provided evidence of CV benefit in the form of significant decreases in the primary CV composite end point, two suggested reductions in CV death, and three suggested reductions in all-cause mortality. Although these trials have yielded much valuable information, whether that information justifies the investment of time and resources is controversial. In June 2016, a Diabetes Care Editors' Expert Forum convened to review the processes and challenges of CVOTs, discuss the benefits and limitations of their current designs, and weigh the merits of modifications that might improve the efficiency and clinical value of future trials. Discussion and analysis continued with the CVOT trial results released in June 2017 at the American Diabetes Association's Scientific Sessions and in September 2017 at the European Association for the Study of Diabetes scientific meeting. This article summarizes the discussion and findings to date.

PMID:
29263194
PMCID:
PMC5741160
DOI:
10.2337/dci17-0057
[Indexed for MEDLINE]
Free PMC Article

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