Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]

FIELD Study Investigators; NHMRC Clinical Trials Ctr; Helsinki Project Off; Christchurch Project Off

doi:10.1186/1475-2840-4-13

Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]

FIELD Study Investigators, NHMRC Clinical Trials Ctr, Helsinki Project Off, Christchurch Project Off

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

80 Citations (Scopus)

Abstract

Objective: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics.

Research design and methods: FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred.

Results: About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of 30), most were men, two-thirds were aged over 60 years, and substantial proportions had NCEP ATP III features of the metabolic syndrome independent of their diabetes, including low HDL (60%), high blood pressure measurement or treatment for hypertension (84%), high waist measurement (68%), and raised triglycerides (52%). After a 6-week run-in period before randomisation with all participants receiving 200 mg comicronized fenofibrate, there were declines in total and LDL cholesterol (10%) and triglycerides (26%) and an increase in HDL cholesterol (6.5%).

Conclusion: The study will show the effect of PPAR-alpha agonist action on CHD and other vascular outcomes in patients with type 2 diabetes including substantial numbers with low to moderate CVD risk but with the various components of the metabolic syndrome. The main results of the study will be reported in late 2005.

Original language	English
Article number	13
Number of pages	9
Journal	Cardiovascular Diabetology
Volume	4
DOIs	https://doi.org/10.1186/1475-2840-4-13
Publication status	Published - 2005

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

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10.1186/1475-2840-4-13

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@article{f88a2c3d01ea47c2905c6a300eb225a6,

title = "Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]",

abstract = "Objective: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics.Research design and methods: FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred.Results: About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of 30), most were men, two-thirds were aged over 60 years, and substantial proportions had NCEP ATP III features of the metabolic syndrome independent of their diabetes, including low HDL (60%), high blood pressure measurement or treatment for hypertension (84%), high waist measurement (68%), and raised triglycerides (52%). After a 6-week run-in period before randomisation with all participants receiving 200 mg comicronized fenofibrate, there were declines in total and LDL cholesterol (10%) and triglycerides (26%) and an increase in HDL cholesterol (6.5%).Conclusion: The study will show the effect of PPAR-alpha agonist action on CHD and other vascular outcomes in patients with type 2 diabetes including substantial numbers with low to moderate CVD risk but with the various components of the metabolic syndrome. The main results of the study will be reported in late 2005.",

author = "{FIELD Study Investigators} and {NHMRC Clinical Trials Ctr} and {Helsinki Project Off} and {Christchurch Project Off} and J. Best and P. Forder and M-R Taskinen and J. Simes and P. Barter and A. Keech and 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 Kesaniemi, {Y. A.} and M. Laakso and Simes, {R. J.} and D. Sullivan and M-R Taskinen and M. Whiting and J-C Ansquer and B. Fraitag and N. Anderson and G. Hankey and D. Hunt 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 P. Barter and I. Beinart and J. Best and S. Bohra and S. Boyages and P. Colman and H. Connor and D. Darnell and P. Davoren and F. Lepre and {De Looze}, F. and M. d'Emden 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 D. Sullivan 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 M. Laakso and J. Lahtela and H. Levanen and J. Saltevo and J. Baker and A. Burton and P. Dixon and N. Graham and J. Lloyd and P. Manning and S. Morris and R. Smith and S. Young and C. Allan and R. Anderson and C. Atkinson and D. Barton and A. Bond and J. Bradshaw and D. Bruce and J. Burgess and J. Butler and J. Campbell and K. Chambers and S. Chow and P. Clifton and P. Coates and C. Cocks and D. Colquhoun and M. Croft and W. Davis and J. Dunn and S. Edwards and L. Emery and M. England and N. Francis and P. Freeman and A. Fuller and J. Goddard and V. Grange and S. Guha and A. Harvey and P. Hay and M. Hines and A. Hodge and L. Hoffman and D. Hunt and A. Hunt and D. Jackson and M. Kotowicz and M. Layton and S. Lean and E. Lim and F. Long and A. Marangou and S. Maxwell and K. McCarthy and H. Mckee and J. McKenzie and P. McNair and B. Morrison and A. Morton and S. Murray and S. Nair and J. Ngui and S. Nicholls and M. O'Neill and C. Pearson and J. Phillips and D. Playford and L. Porter and M. Powell and C. Preston and S. Pringle and G. Ross and J. Rowe and S. Ryan and J. Sansom and J. Shepherd and D. Silva and R. Simpson and M. Smith and P. Smith and P. Stevens and G. Stewart and R. Stewart and M. Sullivan and J. Taylor and D. Torpy and J. Turner and S. Varley and J. Walsh and J. Walshe and G. Ward and J. Watson and A. Webb and E. White and A. Whitehouse and J. Wilkinson and D. Wilson and B. Wong and M. Wong and S. Wright and S. Wu and P. Allan and C. Ballantyne and E. Berry and A. Campbell and T. Clarke and R. Clarke and C. Ferguson and P. Giles and C. Grant and M. Hammond and P. Healy and J. Holland and A. Ireland and A. Johnstone and S. Jones and G. Kerr and B. McLaren and L. McLeod and J. Moffat and M. Pickup and M. Rahman and C. Ross and P. Newman and G. Ritchie and A. Pillai and C. Anderson and S-Y Chan and S. Ford and C. Greig and S. Healy and Z. Hossain and M. Howlett and J. Lee and Li, {L. P.} and T. Matthews and A. Martin and A. Patel and J. Schroeder and B. Sim and R. Taylor and W. Wong and J. Zhang and R. Scott and M. Whiting",

year = "2005",

doi = "10.1186/1475-2840-4-13",

language = "English",

volume = "4",

journal = "Cardiovascular Diabetology",

issn = "1475-2840",

publisher = "BioMed Central",

}

TY - JOUR

T1 - Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

T2 - baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]

AU - FIELD Study Investigators

AU - NHMRC Clinical Trials Ctr

AU - Helsinki Project Off

AU - Christchurch Project Off

AU - Best, J.

AU - Forder, P.

AU - Taskinen, M-R

AU - Simes, J.

AU - Barter, P.

AU - Keech, A.

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, Y. A.

AU - Laakso, M.

AU - Simes, R. J.

AU - Sullivan, D.

AU - Taskinen, M-R

AU - Whiting, M.

AU - Ansquer, J-C

AU - Fraitag, B.

AU - Anderson, N.

AU - Hankey, G.

AU - Hunt, D.

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 - Barter, P.

AU - Beinart, I.

AU - Best, J.

AU - Bohra, S.

AU - Boyages, S.

AU - Colman, P.

AU - Connor, H.

AU - Darnell, D.

AU - Davoren, P.

AU - Lepre, F.

AU - De Looze, F.

AU - d'Emden, M.

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.

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 - Laakso, M.

AU - Lahtela, J.

AU - Levanen, H.

AU - Saltevo, J.

AU - Baker, J.

AU - Burton, A.

AU - Dixon, P.

AU - Graham, N.

AU - Lloyd, J.

AU - Manning, P.

AU - Morris, S.

AU - Smith, R.

AU - Young, S.

AU - Allan, C.

AU - Anderson, R.

AU - Atkinson, C.

AU - Barton, D.

AU - Bond, A.

AU - Bradshaw, J.

AU - Bruce, D.

AU - Burgess, J.

AU - Butler, J.

AU - Campbell, J.

AU - Chambers, K.

AU - Chow, S.

AU - Clifton, P.

AU - Coates, P.

AU - Cocks, C.

AU - Colquhoun, D.

AU - Croft, M.

AU - Davis, W.

AU - Dunn, J.

AU - Edwards, S.

AU - Emery, L.

AU - England, M.

AU - Francis, N.

AU - Freeman, P.

AU - Fuller, A.

AU - Goddard, J.

AU - Grange, V.

AU - Guha, S.

AU - Harvey, A.

AU - Hay, P.

AU - Hines, M.

AU - Hodge, A.

AU - Hoffman, L.

AU - Hunt, D.

AU - Hunt, A.

AU - Jackson, D.

AU - Kotowicz, M.

AU - Layton, M.

AU - Lean, S.

AU - Lim, E.

AU - Long, F.

AU - Marangou, A.

AU - Maxwell, S.

AU - McCarthy, K.

AU - Mckee, H.

AU - McKenzie, J.

AU - McNair, P.

AU - Morrison, B.

AU - Morton, A.

AU - Murray, S.

AU - Nair, S.

AU - Ngui, J.

AU - Nicholls, S.

AU - O'Neill, M.

AU - Pearson, C.

AU - Phillips, J.

AU - Playford, D.

AU - Porter, L.

AU - Powell, M.

AU - Preston, C.

AU - Pringle, S.

AU - Ross, G.

AU - Rowe, J.

AU - Ryan, S.

AU - Sansom, J.

AU - Shepherd, J.

AU - Silva, D.

AU - Simpson, R.

AU - Smith, M.

AU - Smith, P.

AU - Stevens, P.

AU - Stewart, G.

AU - Stewart, R.

AU - Sullivan, M.

AU - Taylor, J.

AU - Torpy, D.

AU - Turner, J.

AU - Varley, S.

AU - Walsh, J.

AU - Walshe, J.

AU - Ward, G.

AU - Watson, J.

AU - Webb, A.

AU - White, E.

AU - Whitehouse, A.

AU - Wilkinson, J.

AU - Wilson, D.

AU - Wong, B.

AU - Wong, M.

AU - Wright, S.

AU - Wu, S.

AU - Allan, P.

AU - Ballantyne, C.

AU - Berry, E.

AU - Campbell, A.

AU - Clarke, T.

AU - Clarke, R.

AU - Ferguson, C.

AU - Giles, P.

AU - Grant, C.

AU - Hammond, M.

AU - Healy, P.

AU - Holland, J.

AU - Ireland, A.

AU - Johnstone, A.

AU - Jones, S.

AU - Kerr, G.

AU - McLaren, B.

AU - McLeod, L.

AU - Moffat, J.

AU - Pickup, M.

AU - Rahman, M.

AU - Ross, C.

AU - Newman, P.

AU - Ritchie, G.

AU - Pillai, A.

AU - Anderson, C.

AU - Chan, S-Y

AU - Ford, S.

AU - Greig, C.

AU - Healy, S.

AU - Hossain, Z.

AU - Howlett, M.

AU - Lee, J.

AU - Li, L. P.

AU - Matthews, T.

AU - Martin, A.

AU - Patel, A.

AU - Schroeder, J.

AU - Sim, B.

AU - Taylor, R.

AU - Wong, W.

AU - Zhang, J.

AU - Scott, R.

AU - Whiting, M.

PY - 2005

Y1 - 2005

N2 - Objective: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics.Research design and methods: FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred.Results: About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of 30), most were men, two-thirds were aged over 60 years, and substantial proportions had NCEP ATP III features of the metabolic syndrome independent of their diabetes, including low HDL (60%), high blood pressure measurement or treatment for hypertension (84%), high waist measurement (68%), and raised triglycerides (52%). After a 6-week run-in period before randomisation with all participants receiving 200 mg comicronized fenofibrate, there were declines in total and LDL cholesterol (10%) and triglycerides (26%) and an increase in HDL cholesterol (6.5%).Conclusion: The study will show the effect of PPAR-alpha agonist action on CHD and other vascular outcomes in patients with type 2 diabetes including substantial numbers with low to moderate CVD risk but with the various components of the metabolic syndrome. The main results of the study will be reported in late 2005.

AB - Objective: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics.Research design and methods: FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred.Results: About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of 30), most were men, two-thirds were aged over 60 years, and substantial proportions had NCEP ATP III features of the metabolic syndrome independent of their diabetes, including low HDL (60%), high blood pressure measurement or treatment for hypertension (84%), high waist measurement (68%), and raised triglycerides (52%). After a 6-week run-in period before randomisation with all participants receiving 200 mg comicronized fenofibrate, there were declines in total and LDL cholesterol (10%) and triglycerides (26%) and an increase in HDL cholesterol (6.5%).Conclusion: The study will show the effect of PPAR-alpha agonist action on CHD and other vascular outcomes in patients with type 2 diabetes including substantial numbers with low to moderate CVD risk but with the various components of the metabolic syndrome. The main results of the study will be reported in late 2005.

U2 - 10.1186/1475-2840-4-13

DO - 10.1186/1475-2840-4-13

M3 - Article

SN - 1475-2840

VL - 4

JO - Cardiovascular Diabetology

JF - Cardiovascular Diabetology

M1 - 13

ER -

Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]

Abstract

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