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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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