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. Sullivan, M. R. Taskinen, M. Whiting, J. C. Ansquer, B. Fraitag, N. Anderson & 493 others G. Hankey, S. Lehto, S. Mann, M. Romo, LP Li, C. Hennekens, S. MacMahon, S. Pocock, A. Tonkin, L. Wilhelmsen, P. Forder, H. Akauola, F. Alford, I. Beinart, S. Bohra, S. Boyages, H. Connor, 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, J. Keen, D. Kilpatrick, J. Kindellan, M. Kingston-Ray, M. Kotowicz, A. Lassig, M. Layton, S. Lean, E. Lim, F. Long, L. Lucas, D. Ludeman, C. Ludeman-Robertson, M. Lyall, L. Lynch, C. Maddison, B. Malkus, A. Marangou, F. Margrie, K. Matthiesson, J. Matthiesson, S. Maxwell, K. McCarthy, A. McElduff, H. McKee, J. McKenzie, K. McLachan, P. McNair, M. Meischke, A. Merkel, C. Miller, B. Morrison, A. Morton, W. Mossman, A. Mowat, J. Muecke, P. Murie, S. Murray, P. Nadorp, S. Nair, J. Nairn, A. Nankervis, K. Narayan, N. Nattrass, J. Ngui, Stephen Nicholls, V. Nicholls, JA Nye, E. Nye, D. O'Neal, M. O'Neill, S. O'Rourke, J. Pearse, C. Pearson, J. Phillips, L. Pittis, D. Playford, L. Porter, R. Portley, M. Powell, C. Preston, S. Pringle, W. A. Quinn, J. Raffaele, G. Ramnath, J. Ramsden, D. Richtsteiger, S. Roffe, S. Rosen, G. Ross, Z. Ross, J. Rowe, D. Rumble, S. Ryan, J. Sansom, C. Seymour, E. Shanahan, S. Shelly, J. Shepherd, G. Sherman, R. Siddall, D. Silva, S. Simmons, R. Simpson, A. Sinha, R. Slobodniuk, M. Smith, P. Smith, S. Smith, V. Smith-Orr, J. Snow, L. Socha, T. Stack, K. Steed, K. Steele, J. Stephensen, P. Stevens, G. Stewart, R. Stewart, C. Strakosch, M. Sullivan, S. Sunder, J. Sunderland, E. Tapp, J. Taylor, D. Thorn, A. Tolley, D. Torpy, G. Truran, F. Turner, J. Turner, J. van de Velde, S. Varley, J. Wallace, J. Walsh, J. Walshe, G. Ward, B. Watson, J. Watson, A. Webb, F. Werner, E. White, A. Whitehouse, N. Whitehouse, S. Wigg, J. Wilkinson, E. Wilmshurst, D. Wilson, Gary Wittert, B. Wong, M. Wong, S. Worboys, S. Wright, S. Wu, J. Yarker, M. Yeo, K. Young, J. Youssef, R. Yuen, H. Zeimer, R. W. Ziffer, A. Aura, A. Friman, J. Hanninen, J. Henell, N. Hyvarinen, M. Ikonen, A. Itkonen, J. Jappinen, A. Jarva, T. Jerkkola, V. Jokinen, J. Juutilainen, H. Kahkonen, T. Kangas, M. Karttunen, P. Kauranen, S. Kortelainen, H. Koukkunen, L. Kumpulainen, T. Laitinen, M. Laitinen, R. Lehto, E. Leinonen, M. Lindstron-Karjalainen, A. Lumiaho, J. Makela, K. Makinen, L. Mannermaa, T. Mard, J. Miettinen, V. Naatti, S. Paavola, N. Parssinen, J. Ripatti, S. Ruotsalainen, A. Salo, M. Siiskonen, A. Soppela, J. Starck, I. Suonranta, L. Ukkola, K. Valli, J. Virolainen, P. Allan, W. Arnold, W. Bagg, K. Balfour, T. Ball, B. Ballantine, C. Ballantyne, C. Barker, F. Bartley, E. Berry, G. Braatvedt, A. Campbell, T. Clarke, R. Clarke, A. Claydon, S. Clayton, P. Cresswell, R. Cutfield, J. Daffurn, J. Delahunt, A. Dissnayake, C. Eagleton, C. Ferguson, C. Florkowski, D. Fry, P. Giles, M. Gluyas, C. Grant, P. Guile, M. Guolo, P. Hale, M. Hammond, P. Healy, M. Hills, J. Hinge, J. Holland, B. Hyne, A. Ireland, A. Johnstone, S. Jones, G. Kerr, K. Kerr, M. Khant, J. Krebs, L. Law, B. Lydon, K. MacAuley, R. McEwan, P. McGregor, B. McLaren, L. McLeod, J. Medforth, R. Miskimmin, J. Moffat, M. Pickup, C. Prentice, M. Rahman, E. Reda, C. Ross, A. Ryalls, D. Schmid, N. Shergill, A. Snaddon, H. Snell, L. Stevens, A. Waterman, V. Watts, K. Jayne, E. Keirnan, P. Newman, G. Ritchie, A. Rosenfeld, E. Beller, V. Gebski, A. Pillai, C. Anderson, S. Blakesmith, S. Y. Chan, S. Czyniewski, A. Dobbie, S. Doshi, A. Dupuy, S. Eckermann, M. Edwards, N. Fields, K. Flood, S. Ford, C. French, S. Gillies, C. Greig, M. Groshens, J. Gu, Y. Guo, W. Hague, S. Healy, L. Hones, Z. Hossain, M. Howlett, J. Lee, L. P. Li, T. Matthews, J. Micallef, A. Martin, I. Minns, A. Nguyen, F. Papuni, A. Patel, R. Pike, M. Pena, K. Pinto, D. Schipp, J. Schroeder, B. Sim, C. Sodhi, T. Sourjina, C. Sutton, R. Taylor, P. Vlagsma, S. Walder, R. Walker, W. Wong, J. Zhang, B. Zhong, A. Kokkonen, P. Narva, E. L. Niemi, A. M. Syrjanen, M. R. Taskinen, C. Lintott, R. Tirimacco, M. Kajosaari, L. Raman, J. Sundvall, M. Tukianen, D. Crimet, I. Sirugue, P. Aubonnet

Research output: Contribution to journalArticle

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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.

LanguageEnglish
Article number9
JournalCardiovascular Diabetology
Volume3
DOIs
Publication statusPublished - 1 Dec 2004

Keywords

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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Cardiology and Cardiovascular Medicine

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. ; Taskinen, M. R. ; Whiting, M. ; Ansquer, J. C. ; 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. ; 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, D. R. ; Suranyi, M. ; Suthers, M. ; Tan, Y. ; Templer, M. ; Topliss, D. ; Waites, J. H. ; 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. ; Keen, J. ; Kilpatrick, D. ; Kindellan, J. ; Kingston-Ray, M. ; Kotowicz, M. ; Lassig, A. ; Layton, M. ; Lean, S. ; Lim, E. ; Long, F. ; Lucas, L. ; Ludeman, D. ; Ludeman-Robertson, C. ; Lyall, M. ; Lynch, L. ; Maddison, C. ; Malkus, B. ; Marangou, A. ; Margrie, F. ; Matthiesson, K. ; Matthiesson, J. ; Maxwell, S. ; McCarthy, K. ; McElduff, A. ; McKee, H. ; McKenzie, J. ; McLachan, K. ; McNair, P. ; Meischke, M. ; Merkel, A. ; Miller, C. ; Morrison, B. ; Morton, A. ; Mossman, W. ; Mowat, A. ; Muecke, J. ; Murie, P. ; Murray, S. ; Nadorp, P. ; Nair, S. ; Nairn, J. ; Nankervis, A. ; Narayan, K. ; Nattrass, N. ; Ngui, J. ; Nicholls, Stephen ; Nicholls, V. ; Nye, JA ; Nye, E. ; O'Neal, D. ; O'Neill, M. ; O'Rourke, S. ; Pearse, J. ; Pearson, C. ; Phillips, J. ; Pittis, L. ; Playford, D. ; Porter, L. ; Portley, R. ; Powell, M. ; Preston, C. ; Pringle, S. ; Quinn, W. A. ; Raffaele, J. ; Ramnath, G. ; Ramsden, J. ; Richtsteiger, D. ; Roffe, S. ; Rosen, S. ; Ross, G. ; Ross, Z. ; Rowe, J. ; Rumble, D. ; Ryan, S. ; Sansom, J. ; Seymour, C. ; Shanahan, E. ; Shelly, S. ; Shepherd, J. ; Sherman, G. ; Siddall, R. ; Silva, D. ; Simmons, S. ; Simpson, R. ; Sinha, A. ; Slobodniuk, R. ; Smith, M. ; Smith, P. ; Smith, S. ; Smith-Orr, V. ; Snow, J. ; Socha, L. ; Stack, T. ; Steed, K. ; Steele, K. ; Stephensen, J. ; Stevens, P. ; Stewart, G. ; Stewart, R. ; Strakosch, C. ; Sullivan, M. ; Sunder, S. ; Sunderland, J. ; Tapp, E. ; Taylor, J. ; Thorn, D. ; Tolley, A. ; Torpy, D. ; Truran, G. ; Turner, F. ; Turner, J. ; van de Velde, J. ; Varley, S. ; Wallace, J. ; Walsh, J. ; Walshe, J. ; Ward, G. ; Watson, B. ; Watson, J. ; Webb, A. ; Werner, F. ; White, E. ; Whitehouse, A. ; Whitehouse, N. ; Wigg, S. ; Wilkinson, J. ; Wilmshurst, E. ; Wilson, D. ; Wittert, Gary ; Wong, B. ; Wong, M. ; Worboys, S. ; Wright, S. ; Wu, S. ; Yarker, J. ; Yeo, M. ; Young, K. ; Youssef, J. ; Yuen, R. ; Zeimer, H. ; Ziffer, R. W. ; Aura, A. ; Friman, A. ; Hanninen, J. ; Henell, J. ; Hyvarinen, N. ; Ikonen, M. ; Itkonen, A. ; Jappinen, J. ; Jarva, A. ; Jerkkola, T. ; Jokinen, V. ; Juutilainen, J. ; Kahkonen, H. ; Kangas, T. ; Karttunen, M. ; Kauranen, P. ; Kortelainen, S. ; Koukkunen, H. ; Kumpulainen, L. ; Laitinen, T. ; Laitinen, M. ; Lehto, R. ; Leinonen, E. ; Lindstron-Karjalainen, M. ; Lumiaho, A. ; Makela, J. ; Makinen, K. ; Mannermaa, L. ; Mard, T. ; Miettinen, J. ; Naatti, V. ; Paavola, S. ; Parssinen, N. ; Ripatti, J. ; Ruotsalainen, S. ; Salo, A. ; Siiskonen, M. ; Soppela, A. ; Starck, J. ; Suonranta, I. ; Ukkola, L. ; Valli, K. ; Virolainen, J. ; Allan, P. ; Arnold, W. ; Bagg, W. ; Balfour, K. ; Ball, T. ; Ballantine, B. ; Ballantyne, C. ; Barker, C. ; Bartley, F. ; Berry, E. ; Braatvedt, G. ; Campbell, A. ; Clarke, T. ; Clarke, R. ; Claydon, A. ; Clayton, S. ; Cresswell, P. ; Cutfield, R. ; Daffurn, J. ; Delahunt, J. ; Dissnayake, A. ; Eagleton, C. ; Ferguson, C. ; Florkowski, C. ; Fry, D. ; Giles, P. ; Gluyas, M. ; Grant, C. ; Guile, P. ; Guolo, M. ; Hale, P. ; Hammond, M. ; Healy, P. ; Hills, M. ; Hinge, J. ; Holland, J. ; Hyne, B. ; Ireland, A. ; Johnstone, A. ; Jones, S. ; Kerr, G. ; Kerr, K. ; Khant, M. ; Krebs, J. ; Law, L. ; Lydon, B. ; MacAuley, K. ; McEwan, R. ; McGregor, P. ; McLaren, B. ; McLeod, L. ; Medforth, J. ; Miskimmin, R. ; Moffat, J. ; Pickup, M. ; Prentice, C. ; Rahman, M. ; Reda, E. ; Ross, C. ; Ryalls, A. ; Schmid, D. ; Shergill, N. ; Snaddon, A. ; Snell, H. ; Stevens, L. ; Waterman, A. ; Watts, V. ; Jayne, K. ; Keirnan, E. ; Newman, P. ; Ritchie, G. ; Rosenfeld, A. ; Beller, E. ; Gebski, V. ; Pillai, A. ; Anderson, C. ; Blakesmith, S. ; Chan, S. Y. ; Czyniewski, S. ; Dobbie, A. ; Doshi, S. ; Dupuy, A. ; Eckermann, S. ; Edwards, M. ; Fields, N. ; Flood, K. ; Ford, S. ; French, C. ; Gillies, S. ; Greig, C. ; Groshens, M. ; Gu, J. ; Guo, Y. ; Hague, W. ; Healy, S. ; Hones, L. ; Hossain, Z. ; Howlett, M. ; Lee, J. ; Li, L. P. ; Matthews, T. ; Micallef, J. ; Martin, A. ; Minns, I. ; Nguyen, A. ; Papuni, F. ; Patel, A. ; Pike, R. ; Pena, M. ; Pinto, K. ; Schipp, D. ; Schroeder, J. ; Sim, B. ; Sodhi, C. ; Sourjina, T. ; Sutton, C. ; Taylor, R. ; Vlagsma, P. ; Walder, S. ; Walker, R. ; Wong, W. ; Zhang, J. ; Zhong, B. ; Kokkonen, A. ; Narva, P. ; Niemi, E. L. ; Syrjanen, A. M. ; Taskinen, M. R. ; Lintott, C. ; Tirimacco, R. ; Kajosaari, M. ; Raman, L. ; Sundvall, J. ; Tukianen, M. ; Crimet, D. ; Sirugue, I. ; Aubonnet, P. / 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]. In: Cardiovascular Diabetology. 2004 ; Vol. 3.
@article{c684ba7b524145de8832d1ebd5563a38,
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 D. Sullivan 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 LP Li 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 H. Connor 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 J. Keen and D. Kilpatrick and J. Kindellan and M. Kingston-Ray and M. Kotowicz and A. Lassig and M. Layton and S. Lean and E. Lim and F. Long and L. Lucas and D. Ludeman and C. Ludeman-Robertson and M. Lyall and L. Lynch and C. Maddison and B. Malkus and A. Marangou and F. Margrie and K. Matthiesson and J. Matthiesson and S. Maxwell and K. McCarthy and A. McElduff and H. McKee and J. McKenzie and K. McLachan and P. McNair and M. Meischke and A. Merkel and C. Miller and B. Morrison and A. Morton and W. Mossman and A. Mowat and J. Muecke and P. Murie and S. Murray and P. Nadorp and S. Nair and J. Nairn and A. Nankervis and K. Narayan and N. Nattrass and J. Ngui and Stephen Nicholls and V. Nicholls and JA Nye and E. Nye and D. O'Neal and M. O'Neill and S. O'Rourke and J. Pearse and C. Pearson and J. Phillips and L. Pittis and D. Playford and L. Porter and R. Portley and M. Powell and C. Preston and S. Pringle and Quinn, {W. A.} and J. Raffaele and G. Ramnath and J. Ramsden and D. Richtsteiger and S. Roffe and S. Rosen and G. Ross and Z. Ross and J. Rowe and D. Rumble and S. Ryan and J. Sansom and C. Seymour and E. Shanahan and S. Shelly and J. Shepherd and G. Sherman and R. Siddall and D. Silva and S. Simmons and R. Simpson and A. Sinha and R. Slobodniuk and M. Smith and P. Smith and S. Smith and V. Smith-Orr and J. Snow and L. Socha and T. Stack and K. Steed and K. Steele and J. Stephensen and P. Stevens and G. Stewart and R. Stewart and C. Strakosch and M. Sullivan and S. Sunder and J. Sunderland and E. Tapp and J. Taylor and D. Thorn and A. Tolley and D. Torpy and G. Truran and F. Turner and J. Turner and {van de Velde}, J. and S. Varley and J. Wallace and J. Walsh and J. Walshe and G. Ward and B. Watson and J. Watson and A. Webb and F. Werner and E. White and A. Whitehouse and N. Whitehouse and S. Wigg and J. Wilkinson and E. Wilmshurst and D. Wilson and Gary Wittert and B. Wong and M. Wong and S. Worboys and S. Wright and S. Wu and J. Yarker and M. Yeo and K. Young and J. Youssef and R. Yuen and H. Zeimer and Ziffer, {R. W.} and A. Aura and A. Friman and J. Hanninen and J. Henell and N. Hyvarinen and M. Ikonen and A. Itkonen and J. Jappinen and A. Jarva and T. Jerkkola and V. Jokinen and J. Juutilainen and H. Kahkonen and T. Kangas and M. Karttunen and P. Kauranen and S. Kortelainen and H. Koukkunen and L. Kumpulainen and T. Laitinen and M. Laitinen and R. Lehto and E. Leinonen and M. Lindstron-Karjalainen and A. Lumiaho and J. Makela and K. Makinen and L. Mannermaa and T. Mard and J. Miettinen and V. Naatti and S. Paavola and N. Parssinen and J. Ripatti and S. Ruotsalainen and A. Salo and M. Siiskonen and A. Soppela and J. Starck and I. Suonranta and L. Ukkola and K. Valli and J. Virolainen and P. Allan and W. Arnold and W. Bagg and K. Balfour and T. Ball and B. Ballantine and C. Ballantyne and C. Barker and F. Bartley and E. Berry and G. Braatvedt and A. Campbell and T. Clarke and R. Clarke and A. Claydon and S. Clayton and P. Cresswell and R. Cutfield and J. Daffurn and J. Delahunt and A. Dissnayake and C. Eagleton and C. Ferguson and C. Florkowski and D. Fry and P. Giles and M. Gluyas and C. Grant and P. Guile and M. Guolo and P. Hale and M. Hammond and P. Healy and M. Hills and J. Hinge and J. Holland and B. Hyne and A. Ireland and A. Johnstone and S. Jones and G. Kerr and K. Kerr and M. Khant and J. Krebs and L. Law and B. Lydon and K. MacAuley and R. McEwan and P. McGregor and B. McLaren and L. McLeod and J. Medforth and R. Miskimmin and J. Moffat and M. Pickup and C. Prentice and M. Rahman and E. Reda and C. Ross and A. Ryalls and D. Schmid and N. Shergill and A. Snaddon and H. Snell and L. Stevens and A. Waterman and V. Watts and K. Jayne and E. Keirnan and P. Newman and G. Ritchie and A. Rosenfeld and E. Beller and V. Gebski and A. Pillai and C. Anderson and S. Blakesmith and Chan, {S. Y.} and S. Czyniewski and A. Dobbie and S. Doshi and A. Dupuy and S. Eckermann and M. Edwards and N. Fields and K. Flood and S. Ford and C. French and S. Gillies and C. Greig and M. Groshens and J. Gu and Y. Guo and W. Hague and S. Healy and L. Hones and Z. Hossain and M. Howlett and J. Lee and Li, {L. P.} and T. Matthews and J. Micallef and A. Martin and I. Minns and A. Nguyen and F. Papuni and A. Patel and R. Pike and M. Pena and K. Pinto and D. Schipp and J. Schroeder and B. Sim and C. Sodhi and T. Sourjina and C. Sutton and R. Taylor and P. Vlagsma and S. Walder and R. Walker and W. Wong and J. Zhang and B. Zhong and A. Kokkonen and P. Narva and Niemi, {E. L.} and Syrjanen, {A. M.} and Taskinen, {M. R.} and C. Lintott and R. Tirimacco and M. Kajosaari and L. Raman and J. Sundvall and M. Tukianen and D. Crimet and I. Sirugue and P. Aubonnet",
year = "2004",
month = "12",
day = "1",
doi = "10.1186/1475-2840-3-9",
language = "English",
volume = "3",
journal = "Cardiovascular Diabetology",
issn = "1475-2840",
publisher = "BioMed Central",

}

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, 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, 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, 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, Keen, J, Kilpatrick, D, Kindellan, J, Kingston-Ray, M, Kotowicz, M, Lassig, A, Layton, M, Lean, S, Lim, E, Long, F, Lucas, L, Ludeman, D, Ludeman-Robertson, C, Lyall, M, Lynch, L, Maddison, C, Malkus, B, Marangou, A, Margrie, F, Matthiesson, K, Matthiesson, J, Maxwell, S, McCarthy, K, McElduff, A, McKee, H, McKenzie, J, McLachan, K, McNair, P, Meischke, M, Merkel, A, Miller, C, Morrison, B, Morton, A, Mossman, W, Mowat, A, Muecke, J, Murie, P, Murray, S, Nadorp, P, Nair, S, Nairn, J, Nankervis, A, Narayan, K, Nattrass, N, Ngui, J, Nicholls, S, Nicholls, V, Nye, JA, Nye, E, O'Neal, D, O'Neill, M, O'Rourke, S, Pearse, J, Pearson, C, Phillips, J, Pittis, L, Playford, D, Porter, L, Portley, R, Powell, M, Preston, C, Pringle, S, Quinn, WA, Raffaele, J, Ramnath, G, Ramsden, J, Richtsteiger, D, Roffe, S, Rosen, S, Ross, G, Ross, Z, Rowe, J, Rumble, D, Ryan, S, Sansom, J, Seymour, C, Shanahan, E, Shelly, S, Shepherd, J, Sherman, G, Siddall, R, Silva, D, Simmons, S, Simpson, R, Sinha, A, Slobodniuk, R, Smith, M, Smith, P, Smith, S, Smith-Orr, V, Snow, J, Socha, L, Stack, T, Steed, K, Steele, K, Stephensen, J, Stevens, P, Stewart, G, Stewart, R, Strakosch, C, Sullivan, M, Sunder, S, Sunderland, J, Tapp, E, Taylor, J, Thorn, D, Tolley, A, Torpy, D, Truran, G, Turner, F, Turner, J, van de Velde, J, Varley, S, Wallace, J, Walsh, J, Walshe, J, Ward, G, Watson, B, Watson, J, Webb, A, Werner, F, White, E, Whitehouse, A, Whitehouse, N, Wigg, S, Wilkinson, J, Wilmshurst, E, Wilson, D, Wittert, G, Wong, B, Wong, M, Worboys, S, Wright, S, Wu, S, Yarker, J, Yeo, M, Young, K, Youssef, J, Yuen, R, Zeimer, H, Ziffer, RW, Aura, A, Friman, A, Hanninen, J, Henell, J, Hyvarinen, N, Ikonen, M, Itkonen, A, Jappinen, J, Jarva, A, Jerkkola, T, Jokinen, V, Juutilainen, J, Kahkonen, H, Kangas, T, Karttunen, M, Kauranen, P, Kortelainen, S, Koukkunen, H, Kumpulainen, L, Laitinen, T, Laitinen, M, Lehto, R, Leinonen, E, Lindstron-Karjalainen, M, Lumiaho, A, Makela, J, Makinen, K, Mannermaa, L, Mard, T, Miettinen, J, Naatti, V, Paavola, S, Parssinen, N, Ripatti, J, Ruotsalainen, S, Salo, A, Siiskonen, M, Soppela, A, Starck, J, Suonranta, I, Ukkola, L, Valli, K, Virolainen, J, Allan, P, Arnold, W, Bagg, W, Balfour, K, Ball, T, Ballantine, B, Ballantyne, C, Barker, C, Bartley, F, Berry, E, Braatvedt, G, Campbell, A, Clarke, T, Clarke, R, Claydon, A, Clayton, S, Cresswell, P, Cutfield, R, Daffurn, J, Delahunt, J, Dissnayake, A, Eagleton, C, Ferguson, C, Florkowski, C, Fry, D, Giles, P, Gluyas, M, Grant, C, Guile, P, Guolo, M, Hale, P, Hammond, M, Healy, P, Hills, M, Hinge, J, Holland, J, Hyne, B, Ireland, A, Johnstone, A, Jones, S, Kerr, G, Kerr, K, Khant, M, Krebs, J, Law, L, Lydon, B, MacAuley, K, McEwan, R, McGregor, P, McLaren, B, McLeod, L, Medforth, J, Miskimmin, R, Moffat, J, Pickup, M, Prentice, C, Rahman, M, Reda, E, Ross, C, Ryalls, A, Schmid, D, Shergill, N, Snaddon, A, Snell, H, Stevens, L, Waterman, A, Watts, V, Jayne, K, Keirnan, E, Newman, P, Ritchie, G, Rosenfeld, A, Beller, E, Gebski, V, Pillai, A, Anderson, C, Blakesmith, S, Chan, SY, Czyniewski, S, Dobbie, A, Doshi, S, Dupuy, A, Eckermann, S, Edwards, M, Fields, N, Flood, K, Ford, S, French, C, Gillies, S, Greig, C, Groshens, M, Gu, J, Guo, Y, Hague, W, Healy, S, Hones, L, Hossain, Z, Howlett, M, Lee, J, Li, LP, Matthews, T, Micallef, J, Martin, A, Minns, I, Nguyen, A, Papuni, F, Patel, A, Pike, R, Pena, M, Pinto, K, Schipp, D, Schroeder, J, Sim, B, Sodhi, C, Sourjina, T, Sutton, C, Taylor, R, Vlagsma, P, Walder, S, Walker, R, Wong, W, Zhang, J, Zhong, B, Kokkonen, A, Narva, P, Niemi, EL, Syrjanen, AM, Taskinen, MR, Lintott, C, Tirimacco, R, Kajosaari, M, Raman, L, Sundvall, J, Tukianen, M, Crimet, D, Sirugue, I & Aubonnet, P 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, 9. https://doi.org/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]. / 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.; Taskinen, M. R.; Whiting, M.; Ansquer, J. C.; 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.; 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, D. R.; Suranyi, M.; Suthers, M.; Tan, Y.; Templer, M.; Topliss, D.; Waites, J. H.; 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.; Keen, J.; Kilpatrick, D.; Kindellan, J.; Kingston-Ray, M.; Kotowicz, M.; Lassig, A.; Layton, M.; Lean, S.; Lim, E.; Long, F.; Lucas, L.; Ludeman, D.; Ludeman-Robertson, C.; Lyall, M.; Lynch, L.; Maddison, C.; Malkus, B.; Marangou, A.; Margrie, F.; Matthiesson, K.; Matthiesson, J.; Maxwell, S.; McCarthy, K.; McElduff, A.; McKee, H.; McKenzie, J.; McLachan, K.; McNair, P.; Meischke, M.; Merkel, A.; Miller, C.; Morrison, B.; Morton, A.; Mossman, W.; Mowat, A.; Muecke, J.; Murie, P.; Murray, S.; Nadorp, P.; Nair, S.; Nairn, J.; Nankervis, A.; Narayan, K.; Nattrass, N.; Ngui, J.; Nicholls, Stephen; Nicholls, V.; Nye, JA; Nye, E.; O'Neal, D.; O'Neill, M.; O'Rourke, S.; Pearse, J.; Pearson, C.; Phillips, J.; Pittis, L.; Playford, D.; Porter, L.; Portley, R.; Powell, M.; Preston, C.; Pringle, S.; Quinn, W. A.; Raffaele, J.; Ramnath, G.; Ramsden, J.; Richtsteiger, D.; Roffe, S.; Rosen, S.; Ross, G.; Ross, Z.; Rowe, J.; Rumble, D.; Ryan, S.; Sansom, J.; Seymour, C.; Shanahan, E.; Shelly, S.; Shepherd, J.; Sherman, G.; Siddall, R.; Silva, D.; Simmons, S.; Simpson, R.; Sinha, A.; Slobodniuk, R.; Smith, M.; Smith, P.; Smith, S.; Smith-Orr, V.; Snow, J.; Socha, L.; Stack, T.; Steed, K.; Steele, K.; Stephensen, J.; Stevens, P.; Stewart, G.; Stewart, R.; Strakosch, C.; Sullivan, M.; Sunder, S.; Sunderland, J.; Tapp, E.; Taylor, J.; Thorn, D.; Tolley, A.; Torpy, D.; Truran, G.; Turner, F.; Turner, J.; van de Velde, J.; Varley, S.; Wallace, J.; Walsh, J.; Walshe, J.; Ward, G.; Watson, B.; Watson, J.; Webb, A.; Werner, F.; White, E.; Whitehouse, A.; Whitehouse, N.; Wigg, S.; Wilkinson, J.; Wilmshurst, E.; Wilson, D.; Wittert, Gary; Wong, B.; Wong, M.; Worboys, S.; Wright, S.; Wu, S.; Yarker, J.; Yeo, M.; Young, K.; Youssef, J.; Yuen, R.; Zeimer, H.; Ziffer, R. W.; Aura, A.; Friman, A.; Hanninen, J.; Henell, J.; Hyvarinen, N.; Ikonen, M.; Itkonen, A.; Jappinen, J.; Jarva, A.; Jerkkola, T.; Jokinen, V.; Juutilainen, J.; Kahkonen, H.; Kangas, T.; Karttunen, M.; Kauranen, P.; Kortelainen, S.; Koukkunen, H.; Kumpulainen, L.; Laitinen, T.; Laitinen, M.; Lehto, R.; Leinonen, E.; Lindstron-Karjalainen, M.; Lumiaho, A.; Makela, J.; Makinen, K.; Mannermaa, L.; Mard, T.; Miettinen, J.; Naatti, V.; Paavola, S.; Parssinen, N.; Ripatti, J.; Ruotsalainen, S.; Salo, A.; Siiskonen, M.; Soppela, A.; Starck, J.; Suonranta, I.; Ukkola, L.; Valli, K.; Virolainen, J.; Allan, P.; Arnold, W.; Bagg, W.; Balfour, K.; Ball, T.; Ballantine, B.; Ballantyne, C.; Barker, C.; Bartley, F.; Berry, E.; Braatvedt, G.; Campbell, A.; Clarke, T.; Clarke, R.; Claydon, A.; Clayton, S.; Cresswell, P.; Cutfield, R.; Daffurn, J.; Delahunt, J.; Dissnayake, A.; Eagleton, C.; Ferguson, C.; Florkowski, C.; Fry, D.; Giles, P.; Gluyas, M.; Grant, C.; Guile, P.; Guolo, M.; Hale, P.; Hammond, M.; Healy, P.; Hills, M.; Hinge, J.; Holland, J.; Hyne, B.; Ireland, A.; Johnstone, A.; Jones, S.; Kerr, G.; Kerr, K.; Khant, M.; Krebs, J.; Law, L.; Lydon, B.; MacAuley, K.; McEwan, R.; McGregor, P.; McLaren, B.; McLeod, L.; Medforth, J.; Miskimmin, R.; Moffat, J.; Pickup, M.; Prentice, C.; Rahman, M.; Reda, E.; Ross, C.; Ryalls, A.; Schmid, D.; Shergill, N.; Snaddon, A.; Snell, H.; Stevens, L.; Waterman, A.; Watts, V.; Jayne, K.; Keirnan, E.; Newman, P.; Ritchie, G.; Rosenfeld, A.; Beller, E.; Gebski, V.; Pillai, A.; Anderson, C.; Blakesmith, S.; Chan, S. Y.; Czyniewski, S.; Dobbie, A.; Doshi, S.; Dupuy, A.; Eckermann, S.; Edwards, M.; Fields, N.; Flood, K.; Ford, S.; French, C.; Gillies, S.; Greig, C.; Groshens, M.; Gu, J.; Guo, Y.; Hague, W.; Healy, S.; Hones, L.; Hossain, Z.; Howlett, M.; Lee, J.; Li, L. P.; Matthews, T.; Micallef, J.; Martin, A.; Minns, I.; Nguyen, A.; Papuni, F.; Patel, A.; Pike, R.; Pena, M.; Pinto, K.; Schipp, D.; Schroeder, J.; Sim, B.; Sodhi, C.; Sourjina, T.; Sutton, C.; Taylor, R.; Vlagsma, P.; Walder, S.; Walker, R.; Wong, W.; Zhang, J.; Zhong, B.; Kokkonen, A.; Narva, P.; Niemi, E. L.; Syrjanen, A. M.; Taskinen, M. R.; Lintott, C.; Tirimacco, R.; Kajosaari, M.; Raman, L.; Sundvall, J.; Tukianen, M.; Crimet, D.; Sirugue, I.; Aubonnet, P.

In: Cardiovascular Diabetology, Vol. 3, 9, 01.12.2004.

Research output: Contribution to journalArticle

TY - JOUR

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

T2 - Cardiovascular Diabetology

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.

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.

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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

VL - 3

JO - Cardiovascular Diabetology

JF - Cardiovascular Diabetology

SN - 1475-2840

M1 - 9

ER -