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]

Barter, P, Best, J, Colman, P, d'Emden, M, Davis, T, Drury, P, Ehnholm, C, Glasziou, P, Hunt, D, Keech, A, Kesaniemi, Y, Laakso, M, Scott, R, Simes, R, Sullivan, D, Taskinen, MR, Whiting, M, Ansquer, JC, Fraitag, B, Anderson, N, Hankey, G, Lehto, S, Mann, S, Romo, M, Li, L, Hennekens, C, MacMahon, S, Pocock, S, Tonkin, A, Wilhelmsen, L, Forder, P, Akauola, H, Alford, F, Beinart, I, Bohra, S, Connor, H, Darnell, D, Davoren, P, Lepre, F, De Looze, F, Duffield, A, Fassett, R, Flack, J, Fulcher, G, Grant, S, Hamwood, S, Harmelin, D, Jackson, R, Jeffries, W, Kamp, M, Kritharides, L, Mahar, L, McCann, V, McIntyre, D, Moses, R, Newnham, H, Nicholson, G, O'Brien, R, Park, K, Petrovsky, N, Phillips, P, Pinn, G, Simmons, D, Stanton, K, Stuckey, B, Sullivan, DR, Suranyi, M, Suthers, M, Tan, Y, Templer, M, Topliss, D, Waites, JH, Watts, G, Welborn, T, Wyndham, R, Haapamaki, H, Kesaniemi, A, Lahtela, J, Levanen, H, Saltevo, J, Sodervik, H, Vanhala, M, Baker, J, Burton, A, Dixon, P, Doran, J, Dunn, P, Graham, N, Hamer, A, Hedley, J, Lloyd, J, Manning, P, McPherson, I, Morris, S, Renner, C, Smith, R, Wackrow, M, Young, S, Alard, F and Kotowicz, Mark 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, vol. 3, pp. 1-11, doi: 10.1186/1475-2840-3-9.

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Title 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]
Author(s) Barter, P
Best, J
Colman, P
d'Emden, M
Davis, T
Drury, P
Ehnholm, C
Glasziou, P
Hunt, D
Keech, A
Kesaniemi, Y
Laakso, M
Scott, R
Simes, R
Sullivan, D
Taskinen, MR
Whiting, M
Ansquer, JC
Fraitag, B
Anderson, N
Hankey, G
Lehto, S
Mann, S
Romo, M
Li, L
Hennekens, C
MacMahon, S
Pocock, S
Tonkin, A
Wilhelmsen, L
Forder, P
Akauola, H
Alford, F
Beinart, I
Bohra, S
Connor, H
Darnell, D
Davoren, P
Lepre, F
De Looze, F
Duffield, A
Fassett, R
Flack, J
Fulcher, G
Grant, S
Hamwood, S
Harmelin, D
Jackson, R
Jeffries, W
Kamp, M
Kritharides, L
Mahar, L
McCann, V
McIntyre, D
Moses, R
Newnham, H
Nicholson, G
O'Brien, R
Park, K
Petrovsky, N
Phillips, P
Pinn, G
Simmons, D
Stanton, K
Stuckey, B
Sullivan, DR
Suranyi, M
Suthers, M
Tan, Y
Templer, M
Topliss, D
Waites, JH
Watts, G
Welborn, T
Wyndham, R
Haapamaki, H
Kesaniemi, A
Lahtela, J
Levanen, H
Saltevo, J
Sodervik, H
Vanhala, M
Baker, J
Burton, A
Dixon, P
Doran, J
Dunn, P
Graham, N
Hamer, A
Hedley, J
Lloyd, J
Manning, P
McPherson, I
Morris, S
Renner, C
Smith, R
Wackrow, M
Young, S
Alard, F
Kotowicz, MarkORCID iD for Kotowicz, Mark
Journal name Cardiovascular diabetology
Volume number 3
Article ID 9
Start page 1
End page 11
Total pages 11
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2004-12-01
ISSN 1475-2840
Keyword(s) diabetes
typical lipid abnormalities
type 2 diabetes mellitus
cardiovascular events
fibrate therapy
Summary 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.
Language eng
DOI 10.1186/1475-2840-3-9
Indigenous content off
Field of Research 1102 Cardiorespiratory Medicine and Haematology
HERDC Research category C1.1 Refereed article in a scholarly journal
Copyright notice ©2004, The FIELD Study Investigators; licensee BioMed Central Ltd
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