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Fenofibrate intervention and event lowering in diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]
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 Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study baseline characteristics and short-term effects of fen.pdf | Published version | 277.19 kB | Adobe PDF | View/Open |
| Title: | Fenofibrate intervention and event lowering in diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481] |
| Authors: | Scott, R Best, J Forder, P Taskinen, M-R Simes, J Barter, P Keech, A 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 Hunt, D Lehto, S Mann, S Romo, M Li, LP Hennekens, C MacMahon, S Pocock, S Tonkin, A Wilhelmsen, L Forder, P Akauola, H Alford, F Barter, P Beinart, I Best, J Bohra, S Boyages, S Colman, P Connor, H Darnell, D Davis, T Davoren, P Lepre, F De Looze, F D'Emden, M 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 Laakso, M Lahtela, J Levanen, H Saltevo, J Sodervik, H Taskinen, M Vanhala, M Baker, J Burton, A Dixon, P Doran, J Drury, P Dunn, P Graham, N Hamer, A Hedley, J Lloyd, J Manning, P McPherson, I Morris, S Renner, C Scott, R Smith, R Wackrow, M Young, S Alard, F Alcoe, J Alford, F 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 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, D Hunt, A Inder, W 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, 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 Miller, AMC 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 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 Thorn, D Tolley, A Torpy, D Truran, G Turner, F Turner, J Van de Velde, J Varley, S Wallace, J Walsh, 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, S 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 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 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 Forder, P 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 Pearse, J 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 Keech, A Simes, RJ Kokkonen, A Narva, P Niemi, E-L Salo, A Syrjanen, A-M Taskinen, M-R Lintott, C Scott, R Tirimacco, R Whiting, M Ehnholm, C Ikonen, M Kajosaari, M Raman, L Sundvall, J Tukianen, M Ansquer, J-C Fraitag, B Crimet, D Sirugue, I Aubonnet, P |
| Item Type: | Journal Article |
| 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 <5%, but nearly all had a 5-year stroke risk of <10%. Despite this, half of the cohort were obese (BMI > 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. |
| Issue Date: | 22-Aug-2005 |
| Date of Acceptance: | 22-Aug-2005 |
| URI: | http://hdl.handle.net/10044/1/83477 |
| DOI: | 10.1186/1475-2840-4-13 |
| ISSN: | 1475-2840 |
| Publisher: | BioMed Central |
| Start Page: | 1 |
| End Page: | 9 |
| Journal / Book Title: | Cardiovascular Diabetology |
| Volume: | 4 |
| Copyright Statement: | © 2005 Keech and 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: | Science & Technology Life Sciences & Biomedicine Cardiac & Cardiovascular Systems Endocrinology & Metabolism Cardiovascular System & Cardiology HIGH-DENSITY-LIPOPROTEIN CORONARY-HEART-DISEASE CARDIOVASCULAR-DISEASE SECONDARY PREVENTION MYOCARDIAL-INFARCTION PLASMA CHOLESTEROL INSULIN ATORVASTATIN BEZAFIBRATE Aged Apolipoproteins B Australia Cardiovascular Diseases Cholesterol Cholesterol, HDL Cholesterol, LDL Coronary Disease Diabetes Complications Diabetes Mellitus, Type 2 Double-Blind Method Female Fenofibrate Finland Humans Hypolipidemic Agents Male Middle Aged New Zealand Obesity Placebos Triglycerides FIELD Study Investigators Humans Cardiovascular Diseases Coronary Disease Diabetes Mellitus, Type 2 Obesity Diabetes Complications Cholesterol Triglycerides Apolipoproteins B Placebos Double-Blind Method Aged Middle Aged Australia Finland New Zealand Female Male Cholesterol, LDL Cholesterol, HDL Hypolipidemic Agents Fenofibrate Science & Technology Life Sciences & Biomedicine Cardiac & Cardiovascular Systems Endocrinology & Metabolism Cardiovascular System & Cardiology HIGH-DENSITY-LIPOPROTEIN CORONARY-HEART-DISEASE CARDIOVASCULAR-DISEASE SECONDARY PREVENTION MYOCARDIAL-INFARCTION PLASMA CHOLESTEROL INSULIN ATORVASTATIN BEZAFIBRATE Cardiovascular System & Hematology 1102 Cardiorespiratory Medicine and Haematology |
| Publication Status: | Published |
| Article Number: | ARTN 13 |
| Online Publication Date: | 2005-08-22 |
| Appears in Collections: | School of Public Health |
This item is licensed under a Creative Commons License
