The need for a large-scale trial of fibrate therapy in diabetes: The rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]

P. Barter, J. Best, P. Colman, M. d'Emden, T. Davis, P. Drury, C. Ehnholm, P. Glasziou, D. Hunt, A. Keech, YA Kesaniemi, M. Laakso, R. Scott, RJ Simes, D. R. Sullivan, M. R. Taskinen, M. Whiting, J. C. Ansquer, B. Fraitag, N. AndersonG. Hankey, S. Lehto, S. Mann, M. Romo, L. P. Li, C. Hennekens, S. MacMahon, S. Pocock, A. Tonkin, L. Wilhelmsen, P. Forder, H. Akauola, F. Alford, I. Beinart, S. Bohra, S. Boyages, J. Flack, D. Darnell, P. Davoren, F. Lepre, F. De Looze, A. Duffield, R. Fassett, J. Flack, G. Fulcher, S. Grant, S. Hamwood, D. Harmelin, R. Jackson, W. Jeffries, M. Kamp, L. Kritharides, L. Mahar, V. McCann, D. McIntyre, R. Moses, H. Newnham, G. Nicholson, R. O'Brien, K. Park, N. Petrovsky, P. Phillips, G. Pinn, D. Simmons, K. Stanton, B. Stuckey, D. R. Sullivan, M. Suranyi, M. Suthers, Y. Tan, M. Templer, D. Topliss, J. H. Waites, G. Watts, T. Welborn, R. Wyndham, H. Haapamaki, A. Kesaniemi, J. Lahtela, H. Levanen, J. Saltevo, H. Sodervik, M. Vanhala, J. Baker, A. Burton, P. Dixon, J. Doran, P. Dunn, N. Graham, A. Hamer, J. Hedley, J. Lloyd, P. Manning, I. McPherson, S. Morris, C. Renner, R. Smith, M. Wackrow, S. Young, F. Alard, J. Alcoe, C. Allan, J. Amerena, R. Anderson, N. Arnold, T. Arsov, D. Ashby, C. Atkinson, L. Badhni, M. Balme, D. Barton, B. Batrouney, C. Beare, T. Beattie, J. Beggs, C. Bendall, A. Benz, A. Bond, R. Bradfield, J. Bradshaw, S. Brearley, D. Bruce, J. Burgess, J. Butler, M. Callary, J. Campbell, K. Chambers, J. Chow, S. Chow, K. Ciszek, P. Clifton, P. Clifton-Bligh, V. Clowes, P. Coates, C. Cocks, S. Cole, D. Colquhoun, M. Correcha, B. Costa, S. Coverdale, M. Croft, J. Crowe, S. Dal Sasso, W. Davis, J. Dunn, S. Edwards, R. Elder, S. El-Kaissi, L. Emery, M. England, O. Farouque, M. Fernandez, B. Fitzpatrick, N. Francis, P. Freeman, A. Fuller, D. Gale, V. Gaylard, C. Gillzan, C. Glatthaar, J. Goddard, V. Grange, T. Greenaway, J. Griffin, A. Grogan, S. Guha, J. Gustafson, PS Hamblin, T. Hannay, C. Hardie, A. Harper, G. Hartl, A. Harvey, S. Havlin, K. Haworth, P. Hay, L. Hay, B. Heenan, R. Hesketh, A. Heyworth, M. Hines, G. Hockings, A. Hodge, L. Hoffman, L. Hoskin, M. Howells, A. Hunt, W. Inder, D. Jackson, A. Jovanovska, K. Kearins, P. Kee, E. Lim, L. Lynch, K. McCarthy, J. McKenzie, C. Miller, S. Murray, S. Nair, S. Nicholls, M. O'Neill, J. Phillips, L. Porter, G. Ramnath, J. Rowe, S. Ryan, J. Shepherd, M. Smith, P. Smith, S. Smith, R. Stewart, M. Sullivan, J. Taylor, J. Turner, J. Walsh, J. Walshe, G. Ward, J. Watson, A. Webb, J. Wilkinson, D. Wilson, B. Wong, M. Wong, S. Wu, M. Yeo, A. Campbell, T. Clarke, P. Hale, M. Hammond, A. Ireland, S. Jones, G. Kerr, M. Rahman, C. Ross, L. Stevens, P. Newman, C. Anderson, S. Eckermann, M. Edwards, S. Ford, Y. Guo, J. Lee, L. P. Li, A. Martin, A. Nguyen, A. Patel, R. Taylor, R. Walker, W. Wong, R. Tirimacco

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Abstract

Background: Fibrates correct the typical lipid abnormalities of type 2 diabetes mellitus, yet no study, to date, has specifically set out to evaluate the role of fibrate therapy in preventing cardiovascular events in this setting.

Methods: Subjects with type 2 diabetes, aged 50-75 years, were screened for eligibility to participate in a long-term trial of comicronized fenofibrate 200 mg daily compared with matching placebo to assess benefits of treatment on the occurrence of coronary and other vascular events. People with total cholesterol levels 3.0-6.5 mmol/L plus either a total-to-HDLc ratio >4.0 or triglyceride level >1.0 mmol /L with no clear indication for lipid-modifying therapy were eligible.

Results: A total of 9795 people were randomized into the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial. All received dietary advice, followed by a 6-week single-blind placebo run-in, then a 6-week active run-in period before randomization. Participants are being followed up every 6 months for outcome events and safety assessments. The study is designed to yield at least 500 coronary events (primary endpoint: first nonfatal myocardial infarction or coronary death) over 5 years, to have 80% power to identify as statistically significant at 2P = 0.05 a 22% reduction in such events, using intention-to-treat methods.

Conclusions: Type 2 diabetes is the most common endocrine disorder worldwide, and its prevalence is increasing. The current evidence about use of fibrates in type 2 diabetes, from around 2000 people treated, will increase with FIELD to evidence from around 12000. FIELD will establish the role of fenofibrate treatment in reducing cardiovascular risk in people with type 2 diabetes. The main results are expected to be available in late 2005.

Original languageEnglish
Article number9
Number of pages11
JournalCardiovascular Diabetology
Volume3
Issue number9
DOIs
Publication statusPublished - 1 Dec 2004
Externally publishedYes

Bibliographical note

'© 2004 The FIELD Study Investigators; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.'

Keywords

  • Cardiovascular disease
  • Coronary heart disease
  • Diabetes mellitus
  • Fibrate
  • Randomized controlled trial
  • Type 2

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    Barter, P., Best, J., Colman, P., d'Emden, M., Davis, T., Drury, P., Ehnholm, C., Glasziou, P., Hunt, D., Keech, A., Kesaniemi, YA., Laakso, M., Scott, R., Simes, RJ., Sullivan, D. R., Taskinen, M. R., Whiting, M., Ansquer, J. C., Fraitag, B., ... Tirimacco, R. (2004). The need for a large-scale trial of fibrate therapy in diabetes: The rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]. Cardiovascular Diabetology, 3(9), [9]. https://doi.org/10.1186/1475-2840-3-9