See also:

FIELD study, 2005	TRC2571
[ISRCTN64783481]	download pdf: fenofibrate | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	fenofibrate 200mg/d
Control treatment	Placebo
Treatments description	total cholesterol change -11.6% at 1 year  LDL change -11.9% at 1 year  HDL change +4.5%

Patients

Patients	participants aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry
Inclusion criteria	total-cholesterol concentration of 3�0�6�5 mmol/L and a total-cholesterol/HDL-cholesterol ratio of 4�0 or more or plasma triglyceride of 1�0�5�0 mmol/L
Exclusion criteria	renal impairment, chronic liver disease, symptomatic gallbladder disease, cardiovascular event within the 3 months before recruitment
Baseline characteristics	Age (mean), yrs 62.2 y  Women (%) 37%  prior MI or CHD (%) 22%  Total cholesterol (mmol/l) 5.03 mmol/L  LDL (mmol/l) 3.07 mmol/L  HDL (mmol/l) 1.10 mmol/L  Triglycerides (mg/dl) 1.73 mmol/L  Diabetes(%) 100%  BMI (kg/m2) 29.8  Stroke history 3.5%

Method and design

Randomized effectives	4895 / 4900 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	5 years
Lost to follow-up	0.22% (22/9795)
Number of centre	63
Geographic area	Australia, New Zealand, Finland
Hypothesis	Superiority
Primary endpoint	coronary events

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
	Studied treat.	Control treat.
Coronary events	256 / 4895 (5,2%)	288 / 4900 (5,9%)	0,89	[0,76;1,05]
Coronary heart disease mortality	110 / 4895 (2,2%)	93 / 4900 (1,9%)	1,18	[0,90;1,56]
Non-fatal myocardial infarction	158 / 4895 (3,2%)	207 / 4900 (4,2%)	0,76	[0,62;0,94]
Total cardiovascular disease events	612 / 4895 (12,5%)	683 / 4900 (13,9%)	0,90	[0,81;0,99]
Cardiovascular disease mortality	140 / 4895 (2,9%)	127 / 4900 (2,6%)	1,10	[0,87;1,40]
Total mortality	356 / 4895 (7,3%)	323 / 4900 (6,6%)	1,10	[0,95;1,28]
Total stroke	158 / 4895 (3,2%)	175 / 4900 (3,6%)	0,90	[0,73;1,12]
Non-haemorrhagic stroke	144 / 4895 (2,9%)	158 / 4900 (3,2%)	0,91	[0,73;1,14]
Coronary revascularisation	290 / 4895 (5,9%)	364 / 4900 (7,4%)	0,80	[0,69;0,93]
All revascularisation�	380 / 4895 (7,8%)	471 / 4900 (9,6%)	0,81	[0,71;0,92]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Coronary event

256 / 4895
288 / 4900
0,89 [0,76;1,05]

All cause death

356 / 4895
323 / 4900
1,10 [0,95;1,28]

Cardiovascular death

140 / 4895
127 / 4900
1,10 [0,87;1,40]

cardiovascular events

612 / 4895
683 / 4900
0,90 [0,81;0,99]

Venous thromboembolism

120 / 4895
80 / 4900
1,50 [1,13;1,99]

Coronary death

110 / 4895
93 / 4900
1,18 [0,90;1,56]

stroke (fatal and non fatal)

158 / 4895
175 / 4900
0,90 [0,73;1,12]

Non fatal MI

158 / 4895
207 / 4900
0,76 [0,62;0,94]

Rhabdomyolysis

3 / 4895
1 / 4900
classic 3,00 [0,31;28,86]

Death from cancer

168 / 4895
148 / 4900
1,14 [0,91;1,41]

Myopathy

2 / 4895
1 / 4900
classic 2,00 [0,18;22,07]

Coronary death and non fatal MI

256 / 4895
288 / 4900
0,89 [0,76;1,05]

Adverse events

38 / 4895
24 / 4900
classic 1,58 [0,95;2,64]

cardiac death

110 / 4895
93 / 4900
1,18 [0,90;1,56] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Coronary event	256 / 4895 (5,2%)	288 / 4900 (5,9%)	0,89	[0,76;1,05]		12545
All cause death	356 / 4895 (7,3%)	323 / 4900 (6,6%)	1,10	[0,95;1,28]
Cardiovascular death	140 / 4895 (2,9%)	127 / 4900 (2,6%)	1,10	[0,87;1,40]
cardiovascular events	612 / 4895 (12,5%)	683 / 4900 (13,9%)	0,90	[0,81;0,99]		0
Venous thromboembolism	120 / 4895 (2,5%)	80 / 4900 (1,6%)	1,50	[1,13;1,99]		12562
Coronary death	110 / 4895 (2,2%)	93 / 4900 (1,9%)	1,18	[0,90;1,56]
stroke (fatal and non fatal)	158 / 4895 (3,2%)	175 / 4900 (3,6%)	0,90	[0,73;1,12]
Non fatal MI	158 / 4895 (3,2%)	207 / 4900 (4,2%)	0,76	[0,62;0,94]
Rhabdomyolysis	3 / 4895 (0,1%)	1 / 4900 (0,0%)	3,00	[0,31;28,86]
Death from cancer	168 / 4895 (3,4%)	148 / 4900 (3,0%)	1,14	[0,91;1,41]
Myopathy	2 / 4895 (0,0%)	1 / 4900 (0,0%)	2,00	[0,18;22,07]		0
Coronary death and non fatal MI	256 / 4895 (5,2%)	288 / 4900 (5,9%)	0,89	[0,76;1,05]
Adverse events	38 / 4895 (0,8%)	24 / 4900 (0,5%)	1,58	[0,95;2,64]
cardiac death	110 / 4895 (2,2%)	93 / 4900 (1,9%)	1,18	[0,90;1,56]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 12545: Jun M, Foote C, Lv J, Neal B, Patel A, Nicholls SJ, Grobbee DE, Cass A, Chalmers J, Perkovic VEffects of fibrates on cardiovascular outcomes: a systematic review and meta-analysis.Lancet 2010 May 10;: 0: 12562: Squizzato A, Galli M, Romualdi E, Dentali F, Kamphuisen PW, Guasti L, Venco A, Ageno WStatins, fibrates, and venous thromboembolism: a meta-analysis.Eur Heart J 2010 May;31:1248-56

Endpoint	studied treat.	control treat.	mean diff
total cholesterol (at 1 y)	4,23 (0,78)	4,56 (0,9)	-0,33	[-0,363;-0,30]
HDL (at 1 y)	1,13 (0,3)	1,12 (0,29)	0,01	[-0,002;0,02]
LDL	2,43 (0,65)	2,6 (0,78)	-0,17	[-0,198;-0,14]

Absolute risk reduction (for a follow-up of 5 years)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
Coronary event	5,23%	5,88%	-0,65%
All cause death	7,27%	6,59%	0,68%
Cardiovascular death	2,86%	2,59%	0,27%
cardiovascular events	12,50%	13,94%	-1,44%
Venous thromboembolism	2,45%	1,63%	0,82%
Coronary death	2,25%	1,90%	0,35%
stroke (fatal and non fatal)	3,23%	3,57%	-0,34%
Non fatal MI	3,23%	4,22%	-1,00%
Rhabdomyolysis	0,61‰	0,20‰	0,04%
Death from cancer	3,43%	3,02%	0,41%
Myopathy	0,41‰	0,20‰	0,02%
Coronary death and non fatal MI	5,23%	5,88%	-0,65%
Adverse events	7,76‰	4,90‰	0,29%
cardiac death	2,25%	1,90%	0,35%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

HDL increasing drugs in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC2571
Trials register #	ISRCTN64783481
Study web site link	http://www.ctc.usyd.edu.au/trials/cardiovascular/field.htm

• . 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].. Cardiovasc Diabetol 2004 Dec 1;3:9
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• Scott R, Best J, Forder P, Taskinen MR, Simes J, Barter P, Keech A. Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481].. Cardiovasc Diabetol 2005 Aug 22;4:13
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• . . Lancet 2005
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• Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, Forder P, Pillai A, Davis T, Glasziou P, Drury P, Kesaniemi YA, Sullivan D, Hunt D, Colman P, d'Emden M, Whiting M, Ehnholm C, Laakso M. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial.. Lancet 2005 Nov 26;366:1849-61
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• Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-J�rvinen H, Keech AC, Taskinen MR. Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus.. J Am Coll Cardiol 2008 Dec 16;52:2190-7 - 10.1016/j.jacc.2008.09.049
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• Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-J�rvinen H, Keech AC, Taskinen MR. Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus.. J Am Coll Cardiol 2008 Dec 16;52:2190-7
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• Rajamani K, Colman PG, Li LP, Best JD, Voysey M, D'Emden MC, Laakso M, Baker JR, Keech AC. Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): a prespecified analysis of a randomised controlled trial.. Lancet 2009 May 23;373:1780-8 - 10.1016/S0140-6736(09)60698-X
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