Trial-Results center  
Clinical trial results database in Heart and vessels Feedback    Home


Related trials

ACCELERATE, 2015 - evacetrapib vs placebo

IMPROVE-IT, 2014 - ezetimibe vs control

dal-OUTCOMES, 2012 - dalcetrapib vs placebo

AIM-HIGH, 2011 - niacin vs placebo (on top statin)

dal-VESSEL, 2011 - dalcetrapib vs placebo

ACCORD lipid, 2010 - fenofibrate vs placebo (on top simvastatine)

SHARP, 2010 - ezetimibe+simvastatin vs placebo

SEARCH, 2010 - simvastatin high dose vs simvastatin

ARBITER-HALTS 6, 2010 - ezetimibe vs niacin

DEFINE, 2010 - anacetrapib vs placebo

Oxford Niaspan Study, 2009 - niacin vs placebo (on top statin)

ARBITER 6-HALTS (niacin vs ezetimibe), 2009 - niacin vs ezetimibe

Emmerich, 2009 - etofibrate vs placebo

ARBITER 2, 2009 - niacin vs placebo (on top statin)

SANDS, 2008 - aggressive treatment vs standard teatment

JUPITER, 2008 - rosuvastatin vs placebo

GISSI-HF rosuvastatine, 2008 - rosuvastatin vs placebo

Tuttle, 2008 - low fat diet vs mediterranean-style diet

RADIANCE 1, 2007 - torcetrapib vs placebo (on top of atorvastatin)

ILLUSTRATE, 2007 - torcetrapib vs placebo (on top of atorvastatin)

CORONA, 2007 - rosuvastatin vs placebo

METEOR, 2007 - rosuvastatin vs placebo

Krum, 2007 - rosuvastatin vs placebo

RADIANCE 2, 2007 - torcetrapib vs placebo (on top of atorvastatin)

ILLUMINATE, 2007 - torcetrapib vs placebo (on top of atorvastatin)



See also:

  • All cardiovascular prevention clinical trials
  • All post myocardial infarction clinical trials
  • All clinical trials of HDL increasing drugs
  • All clinical trials of gemfibrozil
  •  
     VA-HIT study, 1999 TRC2585 
    [NCT00283335] download pdf: gemfibrozil | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment gemfibrozil 1.2g daily
    Control treatment placebo
    Concomittant treatment diet
    Treatments description
    total cholesterol change -4% 
    LDL change 0% 
    HDL change +6% 

    Patients

    Patients men with coronary heart disease, an HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less
    Inclusion criteria documented history of coronary heart disease (defined as a history of myocardial infarction, angina corroborated by objective evidence of ischemia, coronary revascularization, or angiographic evidence of stenosis greater than 50 percent of the luminal diameter in one or more major epicardial coronary arteries), age of less than 74 years, absence of serious coexisting conditions, HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less, and a triglyceride level of 300 mg per deciliter (3.4 mmol per liter) or less
    Baseline characteristics
    Age (mean), yrs 64 
    Women (%)
    prior MI or CHD (%) 100 
    Total cholesterol (mmol/l) 4.5 mmol/L 
    LDL (mmol/l) 2.9 mmol/L 
    HDL (mmol/l) 0.8 mmol/L 
    Triglycerides (mg/dl) 160.5 
    Diabetes(%) 25% 
    BMI (kg/m2) 29 

    Method and design

    Randomized effectives 1264 / 1267 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 5.1 years
    Number of centre 20
    Geographic area USA
    Hypothesis Superiority
    Primary endpoint nonfatal myocardial infarction or death from coronary causes


    Results

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

    Coronary event

    219 / 1264
    275 / 1267
    0,80 [0,68;0,94]

    All cause death

    198 / 1264
    220 / 1267
    0,90 [0,76;1,08]

    cardiovascular events

    258 / 1264
    330 / 1267
    0,78 [0,68;0,90]

    Coronary death

    93 / 1264
    118 / 1267
    0,79 [0,61;1,02]

    stroke (fatal and non fatal)

    58 / 1264
    76 / 1267
    0,76 [0,55;1,07]

    Non fatal MI

    146 / 1264
    184 / 1267
    0,80 [0,65;0,97]

    Death from cancer

    45 / 1264
    51 / 1267
    0,88 [0,60;1,31]

    Cancer

    125 / 1264
    138 / 1267
    0,91 [0,72;1,14]

    cardiac death

    93 / 1264
    118 / 1267
    0,79 [0,61;1,02]

    non cardiovascular death

    102 / 1264
    93 / 1267
    1,10 [0,84;1,44]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 219 / 1264 (17,3%) 275 / 1267 (21,7%) 0,80 [0,68;0,94]   0
    All cause death 198 / 1264 (15,7%) 220 / 1267 (17,4%) 0,90 [0,76;1,08]  
    cardiovascular events 258 / 1264 (20,4%) 330 / 1267 (26,0%) 0,78 [0,68;0,90]   12545
    Coronary death 93 / 1264 (7,4%) 118 / 1267 (9,3%) 0,79 [0,61;1,02]  
    stroke (fatal and non fatal) 58 / 1264 (4,6%) 76 / 1267 (6,0%) 0,76 [0,55;1,07]  
    Non fatal MI 146 / 1264 (11,6%) 184 / 1267 (14,5%) 0,80 [0,65;0,97]  
    Death from cancer 45 / 1264 (3,6%) 51 / 1267 (4,0%) 0,88 [0,60;1,31]  
    Cancer 125 / 1264 (9,9%) 138 / 1267 (10,9%) 0,91 [0,72;1,14]  
    cardiac death 93 / 1264 (7,4%) 118 / 1267 (9,3%) 0,79 [0,61;1,02]  
    non cardiovascular death 102 / 1264 (8,1%) 93 / 1267 (7,3%) 1,10 [0,84;1,44]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:
  • 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;:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 5.1 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 17,33% 21,70% -4,38%
    All cause death 15,66% 17,36% -1,70%
    cardiovascular events 20,41% 26,05% -5,63%
    Coronary death 7,36% 9,31% -1,96%
    stroke (fatal and non fatal) 4,59% 6,00% -1,41%
    Non fatal MI 11,55% 14,52% -2,97%
    Death from cancer 3,56% 4,03% -0,47%
    Cancer 9,89% 10,89% -1,00%
    cardiac death 7,36% 9,31% -1,96%
    non cardiovascular death 8,07% 7,34% 0,73%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    cholesterol lowering intervention in cardiovascular prevention for patients with prior MI or with CHD

    cholesterol lowering intervention in post myocardial infarction for all type of patients

    HDL increasing drugs in cardiovascular prevention for all type of patients



    Reference(s)

    TrialResults-center ID TRC2585
    Trials register # NCT00283335
    • Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J,. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group.. N Engl J Med 1999; 341:410-8
      Pubmed | Hubmed | Fulltext
    • Adabag AS, Mithani S, Al Aloul B, Collins D, Bertog S, Bloomfield HE. Efficacy of gemfibrozil in the primary prevention of atrial fibrillation in a large randomized controlled trial.. Am Heart J 2009 May;157:913-8
      Pubmed | Hubmed | Fulltext

    (c) 2004-2016 TrialResults-center - All Rights Reserved

    Tweet this  |  Facebook  |  notify a friend

    100Heart and vessels