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Systematic review and meta-analysis

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

cardiovascular prevention - antioxydants - secondary prevention

cardiovascular prevention - antioxydants - all type of patients


Related trials

PHS II vitamin C, 2008 - vitamin C vs placebo

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PHS II vitamin E, 2008 - vitamin E vs placebo

WACS beta-caroten, 2007 - beta carotene vs placebo

WACS vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C vs placebo

WHS vitamin E, 2005 - vitamin E vs placebo

SUVIMAX, 2005 - combination vs placebo

HOPE renal insufficiency subgroup, 2004 - vitamin E vs placebo

PHS II beta carotene, 2003 - combination vs placebo

Tepel, 2003 - acetylcysteine vs placebo

WAVE (Waters), 2002 - combination vs placebo

HPS antioxidant, 2002 - combination vs placebo

HATS, 2001 - combination vs placebo

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

ASAP, 2000 - vitamin E vs placebo

SPACE, 2000 - vitamin E vs placebo

WHS beta carotene, 1999 - beta carotene vs placebo

GISSI, 1999 - vitamin E vs control

NSCP (Green) beta carotene, 1999 - beta carotene vs placebo

ATBC 2nd prev subgroup (vitamin E), 1998 - vitamin E vs placebo

ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of combination
    		•  

    HATS study, 2001

    download pdf: combination | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment antioxidant-therapy (vitamins)
    antioxidants given twice daily for a total daily dose of 800 IU of vitamin E (as d-alpha-tocopherol), 1000 mg of vitamin C, 25 mg of natural beta carotene, and 100 �g of selenium
    Control treatment placebo
    Remarks factorial design with simvastatin + niacin

    Patients

    Patients patients with coronary disease, low HDL cholesterol levels and normal LDL cholesterol
    Inclusion criteria men (younger than 63 years of age) and women (younger than 70 years of age) with clinical coronary disease (defined as previous myocardial infarction, coronary interventions, or confirmed angina) and with at least three stenoses of at least 30 percent of the luminal diameter or one stenosis of at least 50 percent; low levels of HDL cholesterol (35 mg per deciliter [0.91 mmol per liter] or lower in men and 40 mg per deciliter [1.03 mmol per liter] in women), LDL cholesterol levels of 145 mg per deciliter (3.75 mmol per liter) or lower, and triglyceride levels below 400 mg per deciliter (4.52 mmol per liter)
    Baseline characteristics
    Women (%) 13% 
    age (yr) 53 y 

    Method and design

    Randomized effectives 84 / 76 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Number of centre 2
    Geographic area USA, Canada
    Hypothesis Superiority
    Primary endpoint change in coronary stenosis


    Results

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

    Cardiovascular death

    1 / 84
         1 / 76
         classic 0,90 [0,06;14,22]

    Non fatal stroke

    2 / 84
         2 / 76
         classic 0,90 [0,13;6,27]

    All cause death

    1 / 84
         1 / 76
         classic 0,90 [0,06;14,22]

    Non fatal MI

    4 / 84
         5 / 76
         classic 0,72 [0,20;2,60]

    cardiovascular events

    6 / 84
         8 / 76
         0,68 [0,25;1,87]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Cardiovascular death 1 / 84 (1,2%) 1 / 76 (1,3%) 0,90 [0,06;14,22] 13138
    Non fatal MI 4 / 84 (4,8%) 5 / 76 (6,6%) 0,72 [0,20;2,60] 13138
    cardiovascular events 6 / 84 (7,1%) 8 / 76 (10,5%) 0,68 [0,25;1,87] 13138
    All cause death 1 / 84 (1,2%) 1 / 76 (1,3%) 0,90 [0,06;14,22] 13138
    Non fatal stroke 2 / 84 (2,4%) 2 / 76 (2,6%) 0,90 [0,13;6,27] cerebral infarction 13138
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 13138: Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJSimvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.N Engl J Med 2001;345:1583-92
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Cardiovascular death 1,19% 1,32% -1,3‰
    Non fatal MI 4,76% 6,58% -18,2‰
    cardiovascular events 7,14% 10,53% -33,8‰
    All cause death 1,19% 1,32% -1,3‰
    Non fatal stroke 2,38% 2,63% -2,5‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for secondary prevention

    antioxydants in cardiovascular prevention for all type of patients



    Reference(s)

    Trials register # NA
    • Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJ. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.. N Engl J Med 2001;345:1583-92
      Pubmed | Hubmed | Fulltext

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