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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 vitamin E
  •  
     HOPE study, 2000 TRC3707 
    download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E 400IU/d from natural sources
    Control treatment matching placebo
    Remarks factorial design of ramipril and vitamin E

    Patients

    Patients women and men 55 years of age or older who were at high risk for cardiovascular events because they had cardiovascular disease or diabetes in addition to one other risk factor.
    Baseline characteristics
    Women (%) 6.7% 

    Method and design

    Randomized effectives 4761 / 4780 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 4.5y
    Premature discontinuation Premature discontinuation for futility
    Number of centre multicenter
    Geographic area Multinational: Canada, USA, Europe, South America
    Hypothesis Superiority
    Primary endpoint CV death, MI, stroke


    Results

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

    Non fatal MI

    532 / 4761
    524 / 4780
    1,02 [0,91;1,14]

    Haemmorhagic stroke

    17 / 4761
    13 / 4780
    classic 1,31 [0,64;2,70]

    stroke (fatal and non fatal)

    209 / 4761
    180 / 4780
    1,17 [0,96;1,42]

    ischemic stroke

    192 / 4761
    167 / 4780
    1,15 [0,94;1,41]

    Cardiovascular death

    342 / 4761
    328 / 4780
    1,05 [0,90;1,21]

    cardiovascular events

    772 / 4761
    739 / 4780
    1,05 [0,96;1,15]

    Non fatal stroke

    209 / 4761
    180 / 4780
    1,17 [0,96;1,42]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    stroke (fatal and non fatal) 209 / 4761 (4,4%) 180 / 4780 (3,8%) 1,17 [0,96;1,42] BMJ 2010  13777
    ischemic stroke 192 / 4761 (4,0%) 167 / 4780 (3,5%) 1,15 [0,94;1,41]   0
    Cardiovascular death 342 / 4761 (7,2%) 328 / 4780 (6,9%) 1,05 [0,90;1,21]  
    cardiovascular events 772 / 4761 (16,2%) 739 / 4780 (15,5%) 1,05 [0,96;1,15]  
    Non fatal stroke 209 / 4761 (4,4%) 180 / 4780 (3,8%) 1,17 [0,96;1,42]  
    Haemmorhagic stroke 17 / 4761 (0,4%) 13 / 4780 (0,3%) 1,31 [0,64;2,70]   0
    Non fatal MI 532 / 4761 (11,2%) 524 / 4780 (11,0%) 1,02 [0,91;1,14]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 13777: Schürks M, Glynn RJ, Rist PM, Tzourio C, Kurth TEffects of vitamin E on stroke subtypes: meta-analysis of randomised controlled trials.BMJ 2010 Nov 4;341:c5702
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 4.5y)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    stroke (fatal and non fatal) 4,39% 3,77% 0,62%
    ischemic stroke 4,03% 3,49% 0,54%
    Cardiovascular death 7,18% 6,86% 0,32%
    cardiovascular events 16,22% 15,46% 0,75%
    Non fatal stroke 4,39% 3,77% 0,62%
    Haemmorhagic stroke 3,57‰ 2,72‰ 0,09%
    Non fatal MI 11,17% 10,96% 0,21%

    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 TRC3707
    Trials register # NA
    • Yusuf S, Dagenais G, Pogue J, Bosch J, Sleight P. Vitamin E supplementation and cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators.. N Engl J Med 2000 Jan 20;342:154-60
      Pubmed | Hubmed | Fulltext
    • Lonn E, Bosch J, Yusuf S, Sheridan P, Pogue J, Arnold JM, Ross C, Arnold A, Sleight P, Probstfield J, Dagenais GR. Effects of long-term vitamin E supplementation on cardiovascular events and cancer: a randomized controlled trial.. JAMA 2005 Mar 16;293:1338-47
      Pubmed | Hubmed | Fulltext

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