Trial-Results center  
Clinical trial results database in cardiology Feedback    Home

Systematic review and meta-analysis

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

cardiovascular prevention - antioxydants - patients with renal disease

cardiovascular prevention - antioxydants - secondary prevention


Related trials

WACS vitamin C, 2007 - vitamin C vs placebo

WACS beta-caroten, 2007 - beta carotene vs placebo

WACS vitamin E, 2007 - vitamin E vs placebo

HOPE renal insufficiency subgroup, 2004 - vitamin E vs placebo

Tepel, 2003 - acetylcysteine vs placebo

WAVE (Waters), 2002 - combination vs placebo

HPS antioxidant, 2002 - combination vs placebo

HATS, 2001 - combination vs placebo

SPACE, 2000 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

GISSI, 1999 - vitamin E vs control

ATBC 2nd prev subgroup (vitamin E), 1998 - vitamin E vs placebo

ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo

MVP, 1997 - combination 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
  •  

    HOPE renal insufficiency subgroup study, 2004

    download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E 400 IU/day, natural
    Control treatment placebo

    Patients

    Patients patients with either known cardiovascular disease or diabetes and at least one additional coronary risk factor and renal insufficiency (sub group)
    Inclusion criteria 55 years or older, had a history of cardiovascular disease (coronary artery disease, stroke, or peripheral arterial disease), or diabetes in the presence of at least one additional cardiovascular risk factor [total cholesterol >5.2 mmol/L, HDL cholesterol¡Ü0.9 mmol/L, hypertension (defined as use of medication(s) to treat high blood pressure or blood pressure at the time of recruitment >160 mm Hg systolic or >90 mm Hg diastolic), known microalbuminuria, or current smoking]
    Exclusion criteria dipstickpositive proteinuria at baseline, serum creatinine >200 lmol/L (2.3 mg/dL), history of congestive heart failure, or known low left ventricular ejection fraction (<40%), hyperkalemia, uncontrolled hypertension, myocardial infarction, unstable angina, or stroke within one month prior to study enrollment; use of or intolerance to vitamin E or ACE inhibitors
    Baseline characteristics
    Women (%) 12.7% 
    age (yr) 68.45y 
    Body mass index 27.6 

    Method and design

    Randomized effectives 499 / 494 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 4.5y
    Number of centre multicentre
    Geographic area North and South America, Europe
    Hypothesis Superiority
    Primary endpoint not defined
    Remarks subgroup analysis

    Remarks / Comments

    Post-hoc analysis



    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Composite of myocardial infarction, stroke, or death from CV causes 115 / 499 (23,0%) 109 / 494 (22,1%) 1,04 [0,83;1,32]
    Myocardial infarction 81 / 499 (16,2%) 83 / 494 (16,8%) 0,97 [0,73;1,28]
    Stroke 26 / 499 (5,2%) 25 / 494 (5,1%) 1,03 [0,60;1,76]
    Death from CV causes 57 / 499 (11,4%) 57 / 494 (11,5%) 0,99 [0,70;1,40]
    Total mortality 85 / 499 (17,0%) 93 / 494 (18,8%) 0,90 [0,69;1,18]
    Unstable angina 76 / 499 (15,2%) 77 / 494 (15,6%) 0,98 [0,73;1,31]
    Heart failure hospitalizations 31 / 499 (6,2%) 28 / 494 (5,7%) 1,10 [0,67;1,80]
    Revascularization procedures 107 / 499 (21,4%) 88 / 494 (17,8%) 1,20 [0,93;1,55]
    Any heart failure 83 / 499 (16,6%) 63 / 494 (12,8%) 1,30 [0,96;1,77]
    Transient ischemic attacks 33 / 499 (6,6%) 34 / 494 (6,9%) 0,96 [0,61;1,53]
    Unstable angina with ECG changes 27 / 499 (5,4%) 32 / 494 (6,5%) 0,84 [0,51;1,37]

    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

    81 / 499
    83 / 494
    0,97 [0,73;1,28]

    Cardiovascular death

    57 / 499
    57 / 494
    0,99 [0,70;1,40]

    cardiovascular events

    115 / 499
    109 / 494
    1,04 [0,83;1,32]

    All cause death

    85 / 499
    93 / 494
    0,90 [0,69;1,18]

    stroke (fatal and non fatal)

    26 / 499
    25 / 494
    1,03 [0,60;1,76]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 81 / 499 (16,2%) 83 / 494 (16,8%) 0,97 [0,73;1,28] Myocardial infarction
    Cardiovascular death 57 / 499 (11,4%) 57 / 494 (11,5%) 0,99 [0,70;1,40] Death from CV causes
    cardiovascular events 115 / 499 (23,0%) 109 / 494 (22,1%) 1,04 [0,83;1,32] Composite of myocardial infarction, stroke, or death from CV causes
    All cause death 85 / 499 (17,0%) 93 / 494 (18,8%) 0,90 [0,69;1,18] Total mortality
    stroke (fatal and non fatal) 26 / 499 (5,2%) 25 / 494 (5,1%) 1,03 [0,60;1,76] Stroke 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 16,23% 16,80% -5,7‰
    Cardiovascular death 11,42% 11,54% -1,2‰
    cardiovascular events 23,05% 22,06% 9,8‰
    All cause death 17,03% 18,83% -17,9‰
    stroke (fatal and non fatal) 5,21% 5,06% 1,5‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for patients with renal disease

    antioxydants in cardiovascular prevention for secondary prevention



    Reference(s)

    Trials register # NA
    • Mann JF, Lonn EM, Yi Q, Gerstein HC, Hoogwerf BJ, Pogue J, Bosch J, Dagenais GR, Yusuf S. Effects of vitamin E on cardiovascular outcomes in people with mild-to-moderate renal insufficiency: results of the HOPE study.. Kidney Int 2004;65:1375-80 - 10.1111/j.1523-1755.2004.00513.x
      Pubmed | Hubmed | Fulltext

    (c) 2004-2011 TrialResults-center - All Rights Reserved

    Tweet this  |  Facebook  |  notify a friend