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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - cholesterol lowering intervention - all chronical situations

cardiovascular prevention - HDL increasing drugs - all type of patients


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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of HDL increasing drugs
  • All clinical trials of fenofibrate
  •  
     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
      Pubmed | Hubmed | Fulltext
    • 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
      Pubmed | Hubmed | Fulltext
    • . . Lancet 2005
      Pubmed | Hubmed | Fulltext
    • 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
      Pubmed | Hubmed | Fulltext
    • Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-Järvinen 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
      Pubmed | Hubmed | Fulltext
    • Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-Järvinen 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
      Pubmed | Hubmed | Fulltext
    • 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
      Pubmed | Hubmed | Fulltext

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