Effects of Fenofibrate Treatment on Cardiovascular Disease Risk in 9,795 Individuals With Type 2 Diabetes and Various Components of the Metabolic Syndrome

The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

  1. Russell Scott, MB CHB, PHD, FRACP1,
  2. Richard O'Brien, MB, PHD, FRACP2,
  3. Greg Fulcher, MB, MD, FRACP3,
  4. Chris Pardy4,
  5. Michael d'Emden, MB BS, PHD, FRACP5,
  6. Dana Tse, PHD4,
  7. Marja-Riitta Taskinen, MD6,
  8. Christian Ehnholm, MD, PHD7,
  9. Anthony Keech, MB BS, FRACP, MSC(EPID)4 and
  10. on behalf of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study Investigators*
  1. 1Lipid and Diabetes Research Group, Christchurch Hospital, Christchurch, New Zealand
  2. 2Department of Medicine, Austin Hospital, University of Melbourne, Melbourne, Australia
  3. 3Diabetes and Endocrinology, Royal North Shore Hospital, University of Sydney, Sydney, Australia
  4. 4National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia
  5. 5Endocrine Research Unit, Royal Brisbane Hospital, Brisbane, Australia
  6. 6Department of Medicine, Helsinki University Central Hospital and Biomedicum, Helsinki, Finland
  7. 7Department of Molecular Medicine, National Public Health Institute, Biomedicum, Helsinki, Finland
  1. Corresponding author: Russell Scott, fieldtrial{at}ctc.usyd.edu.au

Abstract

OBJECTIVE—We explored whether cardiovascular disease (CVD) risk and the effects of fenofibrate differed in subjects with and without metabolic syndrome and according to various features of metabolic syndrome defined by the Adult Treatment Panel III (ATP III) in subjects with type 2 diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.

RESEARCH DESIGN AND METHODS—The prevalence of metabolic syndrome and its features was calculated. Cox proportional models adjusted for age, sex, CVD status, and baseline A1C levels were used to determine the independent contributions of metabolic syndrome features to total CVD event rates and the effects of fenofibrate.

RESULTS—More than 80% of FIELD participants met the ATP III criteria for metabolic syndrome. Each ATP III feature of metabolic syndrome, apart from increased waist circumference, increased the absolute risk of CVD events over 5 years by at least 3%. Those with marked dyslipidemia (elevated triglycerides ≥2.3 mmol/l and low HDL cholesterol) were at the highest risk of CVD (17.8% over 5 years). Fenofibrate significantly reduced CVD events in those with low HDL cholesterol or hypertension. The largest effect of fenofibrate to reduce CVD risk was observed in subjects with marked dyslipidemia in whom a 27% relative risk reduction (95% CI 9–42, P = 0.005; number needed to treat = 23) was observed. Subjects with no prior CVD had greater risk reductions than the entire group.

CONCLUSIONS—Metabolic syndrome components identify higher CVD risk in individuals with type 2 diabetes, so the absolute benefits of fenofibrate are likely to be greater when metabolic syndrome features are present. The highest risk and greatest benefits of fenofibrate are seen among those with marked hypertriglyceridemia.

Footnotes

  • Published ahead of print at http://care.diabetesjournals.org on 4 November 2008.

    Clinical trial reg. no. ISRCTN64783481, www.controlled-trials.com/isrctn.

  • *

    * A complete list of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study contributors is available in an online appendix (http://dx.doi.org/10.2337/dc08-1543).

  • 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.

    The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.

    • Accepted October 27, 2008.
    • Received August 25, 2008.
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This Article

  1. Diabetes Care vol. 32 no. 3 493-498
  1. Online-Only Appendix
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