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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 - primary prevention


Related trials

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

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

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

MVP, 1997 - combination vs placebo

PHS beta carotene, 1996 - beta carotene vs placebo

CARET beta carotene, 1996 - beta carotene vs placebo

CHAOS, 1996 - vitamin E vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of vitamin E
  •  

    PPP study, 2001

    download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E (300 mg/day)
    Control treatment no vitamin E
    Remarks factorial design with aspirin

    Patients

    Patients men and women aged 50 years or greater, with at least one of the major recognised cardiovascular risk factors
    Inclusion criteria people with one or more of the following: hypertension, hypercholesterolaemia, diabetes, obesity, family history of premature myocardial infarction, or individuals who were elderly: old age (>=65 years); hypertension (SBP >=160 mm Hg or DBP>=95 mm Hg on at least three separate occasions); hypercholesterolaemia (total blood cholesterol >=6·4mmol/L on at least two separate occasions); diabetes mellitus (fasting venous plasma glucose concentration >=7·8 mmol/L on at least two separate occasions [chronic drug treatment for any of the three latter conditions was also a criterion for inclusion]); obesity (body mass index >=30 kg/m2); and family history of myocardial infarction before 55 years of age in at least one parent or sibling
    Exclusion criteria treatment with antiplatelet drugs (history of vascular events or diseases); chronic use of anti-inflammatory agents or anticoagulants; contraindications to aspirin; diseases with predictable poor short-term prognosis; and predictable psychological or logistical difficulties affecting compliance with the trial requirements
    Baseline characteristics
    Women (%) 58% 
    age (yr) 64.4 y ( 27% >=70y) 
    Body mass index 27.6 

    Method and design

    Randomized effectives 2231 / 2264 (studied vs. control)
    Design Factorial plan
    Blinding open
    Follow-up duration 3.6y
    Premature discontinuation Premature discontinuation for futility
    Number of centre multicenter
    Geographic area Italy
    Hypothesis Superiority
    Primary endpoint CV events


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    cardiovascular death,non-fatal myocardial infarction, and non-fatal stroke 56 / 2231 (2,5%) 53 / 2264 (2,3%) 1,07 [0,74;1,55]
    Total cardiovascular events or diseases 158 / 2231 (7,1%) 170 / 2264 (7,5%) 0,94 [0,77;1,16]
    All deaths 72 / 2231 (3,2%) 68 / 2264 (3,0%) 1,07 [0,78;1,49]
    Cardiovascular deaths 22 / 2231 (1,0%) 26 / 2264 (1,1%) 0,86 [0,49;1,51]
    Non-cardiovascular deaths 50 / 2231 (2,2%) 42 / 2264 (1,9%) 1,21 [0,80;1,81]
    All myocardial infarction 22 / 2231 (1,0%) 25 / 2264 (1,1%) 0,89 [0,51;1,58]
    Non-fatal myocardial infarction 19 / 2231 (0,9%) 18 / 2264 (0,8%) 1,07 [0,56;2,04]
    All stroke 22 / 2231 (1,0%) 18 / 2264 (0,8%) 1,24 [0,67;2,31]
    Non-fatal stroke 20 / 2231 (0,9%) 13 / 2264 (0,6%) 1,56 [0,78;3,13]
    Angina pectoris 66 / 2231 (3,0%) 55 / 2264 (2,4%) 1,22 [0,86;1,73]
    Transient ischaemic attack 33 / 2231 (1,5%) 35 / 2264 (1,5%) 0,96 [0,60;1,53]
    Peripheral-artery disease 16 / 2231 (0,7%) 30 / 2264 (1,3%) 0,54 [0,30;0,99]
    Revascularisation procedure 27 / 2231 (1,2%) 22 / 2264 (1,0%) 1,25 [0,71;2,18]

    Endpoints used by the meta-analysis and data retained for this trial

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

    Coronary event

    22 / 2231
    25 / 2264
    0,89 [0,51;1,58]

    Cardiovascular death

    22 / 2231
    26 / 2264
    0,86 [0,49;1,51]

    Non fatal MI

    19 / 2231
    18 / 2264
    classic 1,07 [0,56;2,04]

    cardiovascular events

    56 / 2231
    53 / 2264
    1,07 [0,74;1,55]

    Haemmorhagic stroke

    2 / 2231
    0 / 2264
    classic 9,13 [0,15;568,80]

    All cause death

    72 / 2231
    68 / 2264
    1,07 [0,78;1,49]

    stroke (fatal and non fatal)

    22 / 2231
    18 / 2264
    classic 1,24 [0,67;2,31]

    Non fatal stroke

    20 / 2231
    13 / 2264
    classic 1,56 [0,78;3,13]

    ischemic stroke

    20 / 2231
    18 / 2264
    classic 1,13 [0,60;2,13]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 22 / 2231 (1,0%) 25 / 2264 (1,1%) 0,89 [0,51;1,58] All myocardial infarction 
    Cardiovascular death 22 / 2231 (1,0%) 26 / 2264 (1,1%) 0,86 [0,49;1,51]  
    Non fatal MI 19 / 2231 (0,9%) 18 / 2264 (0,8%) 1,07 [0,56;2,04] Non-fatal myocardial infarction 
    cardiovascular events 56 / 2231 (2,5%) 53 / 2264 (2,3%) 1,07 [0,74;1,55]  
    Haemmorhagic stroke 2 / 2231 (0,1%) 0 / 2264 (0,0%) 4,06 [0,18;89,97]   0
    All cause death 72 / 2231 (3,2%) 68 / 2264 (3,0%) 1,07 [0,78;1,49] All deaths 
    stroke (fatal and non fatal) 22 / 2231 (1,0%) 18 / 2264 (0,8%) 1,24 [0,67;2,31] All stroke  0
    Non fatal stroke 20 / 2231 (0,9%) 13 / 2264 (0,6%) 1,56 [0,78;3,13]  
    ischemic stroke 20 / 2231 (0,9%) 18 / 2264 (0,8%) 1,13 [0,60;2,13]   0
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 9,86‰ 1,10% -1,2‰
    Cardiovascular death 9,86‰ 1,15% -1,6‰
    Non fatal MI 8,52‰ 7,95‰ 0,6‰
    cardiovascular events 2,51% 2,34% 1,7‰
    All cause death 3,23% 3,00% 2,2‰
    stroke (fatal and non fatal) 9,86‰ 7,95‰ 1,9‰
    Non fatal stroke 8,96‰ 5,74‰ 3,2‰
    ischemic stroke 8,96‰ 7,95‰ 1,0‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for primary prevention



    Reference(s)

    Trials register # NA
    • de Gaetano G. Low-dose aspirin and vitamin E in people at cardiovascular risk: a randomised trial in general practice. Collaborative Group of the Primary Prevention Project.. Lancet 2001 Jan 13;357:89-95
      Pubmed | Hubmed | Fulltext

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