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Systematic review and meta-analysis

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

cardiovascular prevention - antioxydants - all type of patients

cardiovascular prevention - antioxydants - secondary prevention


Related trials

PHS II (multivitamin), 2012 - combination vs placebo

POPADAD (antioxydant), 2008 - combination vs placebo

ARISE, 2008 - succinobucol vs placebo

PHS II vitamin E, 2008 - vitamin E vs placebo

PHS II vitamin C, 2008 - vitamin C vs placebo

WACS vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C vs placebo

WACS beta-caroten, 2007 - beta carotene vs placebo

SUVIMAX, 2005 - combination vs placebo

WHS vitamin E, 2005 - vitamin E 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

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

HATS, 2001 - combination vs placebo

SPACE, 2000 - vitamin E vs placebo

ASAP, 2000 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

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

WHS beta carotene, 1999 - beta carotene vs placebo

GISSI, 1999 - vitamin E vs control

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
  •  
     HPS antioxidant study, 2002 TRC3698 
    download pdf: combination | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment antioxidant vitamin supplementation (600 mg vitamin E, 250 mg vitamin C, and 20 mg -carotene daily)
    Control treatment matching placebo
    Remarks factorial design with cholesterol lowering therapy

    Patients

    Patients UK adults (aged 40–80) with coronary disease, other occlusive arterial disease, or diabetes
    Inclusion criteria Men and women; aged about 40 years to 80 years; non-fasting blood total cholesterol concentrations of at least 3·5 mmol/L; substantial 5-year risk of death from coronary heart disease because of a past medical history of coronary heart disease, of other occlusive arterial disease, of diabetes mellitus, or of treated hypertension alone
    Exclusion criteria life-threatening conditions, such as chronic liver disease, severe renal disease, severe heart failure, severe chronic airways disease, or diagnosed cancer (other than non-melanoma skin cancer); high-dose vitamin E supplements

    Method and design

    Randomized effectives 10269 / 10267 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration jul 1994 - may 1997
    Number of centre 69
    Geographic area UK
    Hypothesis Superiority
    Primary endpoint coronary events


    Results

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

    Coronary event

    1063 / 10269
    1047 / 10267
    1,02 [0,94;1,10]

    stroke (fatal and non fatal)

    511 / 10269
    518 / 10267
    0,99 [0,88;1,11]

    Cardiovascular death

    878 / 10269
    840 / 10267
    1,05 [0,95;1,14]

    cardiovascular events

    2306 / 10269
    2312 / 10267
    1,00 [0,95;1,05]

    All cause death

    1446 / 10269
    1389 / 10267
    1,04 [0,97;1,11]

    Non fatal stroke

    430 / 10269
    435 / 10267
    0,99 [0,87;1,13]

    Non fatal MI

    464 / 10269
    467 / 10267
    0,99 [0,88;1,13]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 1063 / 10269 (10,4%) 1047 / 10267 (10,2%) 1,02 [0,94;1,10]   2942
    stroke (fatal and non fatal) 511 / 10269 (5,0%) 518 / 10267 (5,0%) 0,99 [0,88;1,11]   2942
    Cardiovascular death 878 / 10269 (8,6%) 840 / 10267 (8,2%) 1,05 [0,95;1,14]   2942
    cardiovascular events 2306 / 10269 (22,5%) 2312 / 10267 (22,5%) 1,00 [0,95;1,05] fig 3  2942
    All cause death 1446 / 10269 (14,1%) 1389 / 10267 (13,5%) 1,04 [0,97;1,11]   2942
    Non fatal stroke 430 / 10269 (4,2%) 435 / 10267 (4,2%) 0,99 [0,87;1,13]   2942
    Non fatal MI 464 / 10269 (4,5%) 467 / 10267 (4,5%) 0,99 [0,88;1,13]   2942
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 2942: MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20,536 high-risk individuals: a randomised placebo-controlled trial.Lancet 2002 Jul 6;360:23-33
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of jul 1994 - may 1997)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 10,35% 10,20% 0,15%
    stroke (fatal and non fatal) 4,98% 5,05% -0,07%
    Cardiovascular death 8,55% 8,18% 0,37%
    cardiovascular events 22,46% 22,52% -0,06%
    All cause death 14,08% 13,53% 0,55%
    Non fatal stroke 4,19% 4,24% -0,05%
    Non fatal MI 4,52% 4,55% -0,03%

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for secondary prevention



    Reference(s)

    TrialResults-center ID TRC3698
    Trials register # NA
    • . MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20,536 high-risk individuals: a randomised placebo-controlled trial.. Lancet 2002 Jul 6;360:23-33
      Pubmed | Hubmed | Fulltext

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