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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 - all type of patients


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AREDS, 2001 - vitamin E vs placebo

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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of acetylcysteine
    		•  

    Tepel study, 2003

    download pdf: acetylcysteine | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment acetylcysteine 600 mg twice daily
    Control treatment placebo

    Patients

    Patients patients undergoing maintenance hemodialysis for a minimum of 3 months 3 times weekly in an ambulatory center
    Inclusion criteria not defined
    Baseline characteristics
    Women (%) 43% 
    age (yr) 62 y 
    Body mass index 23 

    Method and design

    Randomized effectives 64 / 70 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 14.5 y
    Number of centre single centre
    Geographic area Germany
    Hypothesis Superiority
    Primary endpoint cardiovascular event


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    CV events 18 / 64 (28,1%) 33 / 70 (47,1%) 0,60 [0,38;0,95]
    Cardiac event 9 / 64 (14,1%) 14 / 70 (20,0%) 0,70 [0,33;1,51]
    Ischemic stroke 2 / 64 (3,1%) 7 / 70 (10,0%) 0,31 [0,07;1,45]
    Peripheral vascular disease 7 / 64 (10,9%) 12 / 70 (17,1%) 0,64 [0,27;1,52]
    death any cause 14 / 64 (21,9%) 14 / 70 (20,0%) 1,09 [0,57;2,11]
    Cardiovascular death 9 / 64 (14,1%) 8 / 70 (11,4%) 1,23 [0,51;3,00]

    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

    9 / 64
         14 / 70
         0,70 [0,33;1,51]

    Cardiovascular death

    9 / 64
         8 / 70
         classic 1,23 [0,51;3,00]

    ischemic stroke

    2 / 64
         7 / 70
         0,31 [0,07;1,45]

    All cause death

    14 / 64
         14 / 70
         classic 1,09 [0,57;2,11]

    cardiovascular events

    18 / 64
         33 / 70
         0,60 [0,38;0,95]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 9 / 64 (14,1%) 14 / 70 (20,0%) 0,70 [0,33;1,51] Cardiac event 
    All cause death 14 / 64 (21,9%) 14 / 70 (20,0%) 1,09 [0,57;2,11] death any cause 
    ischemic stroke 2 / 64 (3,1%) 7 / 70 (10,0%) 0,31 [0,07;1,45] Ischemic stroke  0
    Cardiovascular death 9 / 64 (14,1%) 8 / 70 (11,4%) 1,23 [0,51;3,00] Cardiovascular death 
    cardiovascular events 18 / 64 (28,1%) 33 / 70 (47,1%) 0,60 [0,38;0,95] CV events 
    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 14,06% 20,00% -59,4‰
    All cause death 21,88% 20,00% 1,9%
    ischemic stroke 3,13% 10,00% -68,8‰
    Cardiovascular death 14,06% 11,43% 2,6%
    cardiovascular events 28,13% 47,14% -190,2‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for patients with renal disease



    Reference(s)

    Trials register # NA
    • Tepel M, van der Giet M, Statz M, Jankowski J, Zidek W. The antioxidant acetylcysteine reduces cardiovascular events in patients with end-stage renal failure: a randomized, controlled trial.. Circulation 2003;107:992-5
      Pubmed | Hubmed | Fulltext

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