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. Anderson; G. 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

doi:10.1186/1475-2840-3-9

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

Research output: Contribution to journal › Article › peer-review

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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 language	English
Article number	9
Number of pages	11
Journal	Cardiovascular Diabetology
Volume	3
Issue number	9
DOIs	https://doi.org/10.1186/1475-2840-3-9
Publication status	Published - 1 Dec 2004
Externally published	Yes

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1186/1475-2840-3-9Licence: CC BY

FIELD_Need_P2004Final published version, 312 KBLicence: CC BY

Cite this

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), Article 9. https://doi.org/10.1186/1475-2840-3-9

@article{a5e5cc7d1cf74ae3ae920bfdd048edbd,

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]",

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.",

keywords = "Cardiovascular disease, Coronary heart disease, Diabetes mellitus, Fibrate, Randomized controlled trial, Type 2",

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

note = "'{\textcopyright} 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.'",

year = "2004",

month = dec,

day = "1",

doi = "10.1186/1475-2840-3-9",

language = "English",

volume = "3",

journal = "Cardiovascular Diabetology",

issn = "1475-2840",

publisher = "Springer Open",

number = "9",

}

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, DR, Taskinen, MR, Whiting, M, Ansquer, JC, Fraitag, B, Anderson, N, Hankey, G, Lehto, S, Mann, S, Romo, M, Li, LP, Hennekens, C, MacMahon, S, Pocock, S, Tonkin, A, Wilhelmsen, L, Forder, P, Akauola, H, Alford, F, Beinart, I, Bohra, S, Boyages, S, Flack, J, 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, Alcoe, J, Allan, C, Amerena, J, Anderson, R, Arnold, N, Arsov, T, Ashby, D, Atkinson, C, Badhni, L, Balme, M, Barton, D, Batrouney, B, Beare, C, Beattie, T, Beggs, J, Bendall, C, Benz, A, Bond, A, Bradfield, R, Bradshaw, J, Brearley, S, Bruce, D, Burgess, J, Butler, J, Callary, M, Campbell, J, Chambers, K, Chow, J, Chow, S, Ciszek, K, Clifton, P, Clifton-Bligh, P, Clowes, V, Coates, P, Cocks, C, Cole, S, Colquhoun, D, Correcha, M, Costa, B, Coverdale, S, Croft, M, Crowe, J, Dal Sasso, S, Davis, W, Dunn, J, Edwards, S, Elder, R, El-Kaissi, S, Emery, L, England, M, Farouque, O, Fernandez, M, Fitzpatrick, B, Francis, N, Freeman, P, Fuller, A, Gale, D, Gaylard, V, Gillzan, C, Glatthaar, C, Goddard, J, Grange, V, Greenaway, T, Griffin, J, Grogan, A, Guha, S, Gustafson, J, Hamblin, PS, Hannay, T, Hardie, C, Harper, A, Hartl, G, Harvey, A, Havlin, S, Haworth, K, Hay, P, Hay, L, Heenan, B, Hesketh, R, Heyworth, A, Hines, M, Hockings, G, Hodge, A, Hoffman, L, Hoskin, L, Howells, M, Hunt, A, Inder, W, Jackson, D, Jovanovska, A, Kearins, K, Kee, P, Lim, E, Lynch, L, McCarthy, K, McKenzie, J, Miller, C, Murray, S, Nair, S, Nicholls, S, O'Neill, M, Phillips, J, Porter, L, Ramnath, G, Rowe, J, Ryan, S, Shepherd, J, Smith, M, Smith, P, Smith, S, Stewart, R, Sullivan, M, Taylor, J, Turner, J, Walsh, J, Walshe, J, Ward, G, Watson, J, Webb, A, Wilkinson, J, Wilson, D, Wong, B, Wong, M, Wu, S, Yeo, M, Campbell, A, Clarke, T, Hale, P, Hammond, M, Ireland, A, Jones, S, Kerr, G, Rahman, M, Ross, C, Stevens, L, Newman, P, Anderson, C, Eckermann, S, Edwards, M, Ford, S, Guo, Y, Lee, J, Li, LP, Martin, A, Nguyen, A, Patel, A, Taylor, R, Walker, R, Wong, W & 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, vol. 3, no. 9, 9. https://doi.org/10.1186/1475-2840-3-9

TY - JOUR

T1 - The need for a large-scale trial of fibrate therapy in diabetes

T2 - The rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]

AU - Barter, P.

AU - Best, J.

AU - Colman, P.

AU - d'Emden, M.

AU - Davis, T.

AU - Drury, P.

AU - Ehnholm, C.

AU - Glasziou, P.

AU - Hunt, D.

AU - Keech, A.

AU - Kesaniemi, YA

AU - Laakso, M.

AU - Scott, R.

AU - Simes, RJ

AU - Sullivan, D. R.

AU - Taskinen, M. R.

AU - Whiting, M.

AU - Ansquer, J. C.

AU - Fraitag, B.

AU - Anderson, N.

AU - Hankey, G.

AU - Lehto, S.

AU - Mann, S.

AU - Romo, M.

AU - Li, L. P.

AU - Hennekens, C.

AU - MacMahon, S.

AU - Pocock, S.

AU - Tonkin, A.

AU - Wilhelmsen, L.

AU - Forder, P.

AU - Akauola, H.

AU - Alford, F.

AU - Beinart, I.

AU - Bohra, S.

AU - Boyages, S.

AU - Flack, J.

AU - Darnell, D.

AU - Davoren, P.

AU - Lepre, F.

AU - De Looze, F.

AU - Duffield, A.

AU - Fassett, R.

AU - Flack, J.

AU - Fulcher, G.

AU - Grant, S.

AU - Hamwood, S.

AU - Harmelin, D.

AU - Jackson, R.

AU - Jeffries, W.

AU - Kamp, M.

AU - Kritharides, L.

AU - Mahar, L.

AU - McCann, V.

AU - McIntyre, D.

AU - Moses, R.

AU - Newnham, H.

AU - Nicholson, G.

AU - O'Brien, R.

AU - Park, K.

AU - Petrovsky, N.

AU - Phillips, P.

AU - Pinn, G.

AU - Simmons, D.

AU - Stanton, K.

AU - Stuckey, B.

AU - Sullivan, D. R.

AU - Suranyi, M.

AU - Suthers, M.

AU - Tan, Y.

AU - Templer, M.

AU - Topliss, D.

AU - Waites, J. H.

AU - Watts, G.

AU - Welborn, T.

AU - Wyndham, R.

AU - Haapamaki, H.

AU - Kesaniemi, A.

AU - Lahtela, J.

AU - Levanen, H.

AU - Saltevo, J.

AU - Sodervik, H.

AU - Vanhala, M.

AU - Baker, J.

AU - Burton, A.

AU - Dixon, P.

AU - Doran, J.

AU - Dunn, P.

AU - Graham, N.

AU - Hamer, A.

AU - Hedley, J.

AU - Lloyd, J.

AU - Manning, P.

AU - McPherson, I.

AU - Morris, S.

AU - Renner, C.

AU - Smith, R.

AU - Wackrow, M.

AU - Young, S.

AU - Alard, F.

AU - Alcoe, J.

AU - Allan, C.

AU - Amerena, J.

AU - Anderson, R.

AU - Arnold, N.

AU - Arsov, T.

AU - Ashby, D.

AU - Atkinson, C.

AU - Badhni, L.

AU - Balme, M.

AU - Barton, D.

AU - Batrouney, B.

AU - Beare, C.

AU - Beattie, T.

AU - Beggs, J.

AU - Bendall, C.

AU - Benz, A.

AU - Bond, A.

AU - Bradfield, R.

AU - Bradshaw, J.

AU - Brearley, S.

AU - Bruce, D.

AU - Burgess, J.

AU - Butler, J.

AU - Callary, M.

AU - Campbell, J.

AU - Chambers, K.

AU - Chow, J.

AU - Chow, S.

AU - Ciszek, K.

AU - Clifton, P.

AU - Clifton-Bligh, P.

AU - Clowes, V.

AU - Coates, P.

AU - Cocks, C.

AU - Cole, S.

AU - Colquhoun, D.

AU - Correcha, M.

AU - Costa, B.

AU - Coverdale, S.

AU - Croft, M.

AU - Crowe, J.

AU - Dal Sasso, S.

AU - Davis, W.

AU - Dunn, J.

AU - Edwards, S.

AU - Elder, R.

AU - El-Kaissi, S.

AU - Emery, L.

AU - England, M.

AU - Farouque, O.

AU - Fernandez, M.

AU - Fitzpatrick, B.

AU - Francis, N.

AU - Freeman, P.

AU - Fuller, A.

AU - Gale, D.

AU - Gaylard, V.

AU - Gillzan, C.

AU - Glatthaar, C.

AU - Goddard, J.

AU - Grange, V.

AU - Greenaway, T.

AU - Griffin, J.

AU - Grogan, A.

AU - Guha, S.

AU - Gustafson, J.

AU - Hamblin, PS

AU - Hannay, T.

AU - Hardie, C.

AU - Harper, A.

AU - Hartl, G.

AU - Harvey, A.

AU - Havlin, S.

AU - Haworth, K.

AU - Hay, P.

AU - Hay, L.

AU - Heenan, B.

AU - Hesketh, R.

AU - Heyworth, A.

AU - Hines, M.

AU - Hockings, G.

AU - Hodge, A.

AU - Hoffman, L.

AU - Hoskin, L.

AU - Howells, M.

AU - Hunt, A.

AU - Inder, W.

AU - Jackson, D.

AU - Jovanovska, A.

AU - Kearins, K.

AU - Kee, P.

AU - Lim, E.

AU - Lynch, L.

AU - McCarthy, K.

AU - McKenzie, J.

AU - Miller, C.

AU - Murray, S.

AU - Nair, S.

AU - Nicholls, S.

AU - O'Neill, M.

AU - Phillips, J.

AU - Porter, L.

AU - Ramnath, G.

AU - Rowe, J.

AU - Ryan, S.

AU - Shepherd, J.

AU - Smith, M.

AU - Smith, P.

AU - Smith, S.

AU - Stewart, R.

AU - Sullivan, M.

AU - Taylor, J.

AU - Turner, J.

AU - Walsh, J.

AU - Walshe, J.

AU - Ward, G.

AU - Watson, J.

AU - Webb, A.

AU - Wilkinson, J.

AU - Wilson, D.

AU - Wong, B.

AU - Wong, M.

AU - Wu, S.

AU - Yeo, M.

AU - Campbell, A.

AU - Clarke, T.

AU - Hale, P.

AU - Hammond, M.

AU - Ireland, A.

AU - Jones, S.

AU - Kerr, G.

AU - Rahman, M.

AU - Ross, C.

AU - Stevens, L.

AU - Newman, P.

AU - Anderson, C.

AU - Eckermann, S.

AU - Edwards, M.

AU - Ford, S.

AU - Guo, Y.

AU - Lee, J.

AU - Li, L. P.

AU - Martin, A.

AU - Nguyen, A.

AU - Patel, A.

AU - Taylor, R.

AU - Walker, R.

AU - Wong, W.

AU - Tirimacco, R.

N1 - '© 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.'

PY - 2004/12/1

Y1 - 2004/12/1

N2 - 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.

AB - 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.

KW - Cardiovascular disease

KW - Coronary heart disease

KW - Diabetes mellitus

KW - Fibrate

KW - Randomized controlled trial

KW - Type 2

UR - http://www.scopus.com/inward/record.url?scp=12444318777&partnerID=8YFLogxK

U2 - 10.1186/1475-2840-3-9

DO - 10.1186/1475-2840-3-9

M3 - Article

AN - SCOPUS:12444318777

SN - 1475-2840

VL - 3

JO - Cardiovascular Diabetology

JF - Cardiovascular Diabetology

IS - 9

M1 - 9

ER -

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]

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