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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

POPADAD (antioxydant), 2008 - combination vs placebo

ARISE, 2008 - succinobucol vs placebo

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
    		•  

    WAVE (Waters) study, 2002

    download pdf: combination | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment 400 IU of vitamin E twice daily plus 500 mg of vitamin C twice daily
    Control treatment placebo
    Remarks factorial design of 0.625 mg/d of conjugated equine estrogen (plus 2.5 mg/d of medroxyprogesterone acetate for women who had not had a hysterectomy)

    Patients

    Patients postmenopausal women with at least one 15% to 75% coronary stenosis
    Baseline characteristics
    Women (%) 100% 
    age (yr) 65 y 
    Body mass index 31 

    Method and design

    Randomized effectives 212 / 211 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 2.8 years
    Number of centre 7
    Geographic area US, Canada
    Hypothesis Superiority
    Primary endpoint change in minimum lumen diameter


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    All deaths 16 / 212 (7,5%) 6 / 211 (2,8%) 2,65 [1,06;6,65]
    Cardiovascular deaths 10 / 212 (4,7%) 4 / 211 (1,9%) 2,49 [0,79;7,81]
    Nonfatal MI 4 / 212 (1,9%) 4 / 211 (1,9%) 1,00 [0,25;3,93]
    Death or nonfatal MI 20 / 212 (9,4%) 10 / 211 (4,7%) 1,99 [0,95;4,15]
    Cardiovascular death or nonfatal MI 14 / 212 (6,6%) 8 / 211 (3,8%) 1,74 [0,75;4,06]
    Stroke 6 / 212 (2,8%) 7 / 211 (3,3%) 0,85 [0,29;2,50]
    Death, nonfatal MI, or stroke 26 / 212 (12,3%) 18 / 211 (8,5%) 1,44 [0,81;2,54]
    PCI or CABG surgery 40 / 212 (18,9%) 38 / 211 (18,0%) 1,05 [0,70;1,56]
    Pulmonary embolus or deep vein thrombosis 5 / 212 (2,4%) 3 / 211 (1,4%) 1,66 [0,40;6,85]
    Not calculable (data not available)
    Breast Cancer 3 / 212 (1,4%) 1 / 211 (0,5%) 2,99 [0,31;28,48]
    Other cancer 3 / 212 (1,4%) 4 / 211 (1,9%) 0,75 [0,17;3,29]

    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]

    Cardiovascular death

    10 / 212
         4 / 211
         classic 2,49 [0,79;7,81]

    Non fatal MI

    4 / 212
         4 / 211
         classic 1,00 [0,25;3,93]

    All cause death

    16 / 212
         6 / 211
         classic 2,65 [1,06;6,65]

    stroke (fatal and non fatal)

    6 / 212
         7 / 211
         classic 0,85 [0,29;2,50]

    cardiovascular events

    25 / 212
         16 / 211
         classic 1,56 [0,86;2,83]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Cardiovascular death 10 / 212 (4,7%) 4 / 211 (1,9%) 2,49 [0,79;7,81]   2949
    Non fatal MI 4 / 212 (1,9%) 4 / 211 (1,9%) 1,00 [0,25;3,93]   2949
    cardiovascular events 25 / 212 (11,8%) 16 / 211 (7,6%) 1,56 [0,86;2,83] death,MI, stroke  2949
    All cause death 16 / 212 (7,5%) 6 / 211 (2,8%) 2,65 [1,06;6,65]   2949
    stroke (fatal and non fatal) 6 / 212 (2,8%) 7 / 211 (3,3%) 0,85 [0,29;2,50]   2949
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 2949: Waters DD, Alderman EL, Hsia J, Howard BV, Cobb FR, Rogers WJ, Ouyang P, Thompson P, Tardif JC, Higginson L, Bittner V, Steffes M, Gordon DJ, Proschan M, Younes N, Verter JIEffects of hormone replacement therapy and antioxidant vitamin supplements on coronary atherosclerosis in postmenopausal women: a randomized controlled trial.JAMA 2002 Nov 20;288:2432-40
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Cardiovascular death 4,72% 1,90% 2,8%
    Non fatal MI 1,89% 1,90% -0,1‰
    cardiovascular events 11,79% 7,58% 4,2%
    All cause death 7,55% 2,84% 4,7%
    stroke (fatal and non fatal) 2,83% 3,32% -4,9‰

    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
    • Waters DD, Alderman EL, Hsia J, Howard BV, Cobb FR, Rogers WJ, Ouyang P, Thompson P, Tardif JC, Higginson L, Bittner V, Steffes M, Gordon DJ, Proschan M, Younes N, Verter JI. Effects of hormone replacement therapy and antioxidant vitamin supplements on coronary atherosclerosis in postmenopausal women: a randomized controlled trial.. JAMA 2002 Nov 20;288:2432-40
      Pubmed | Hubmed | Fulltext

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