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See also:

  • All cardiovascular prevention clinical trials
  • All diabetes type 2 clinical trials
  • All peripheral vascular diseases clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of combination
  •  
     POPADAD (antioxydant) study, 2008 TRC8776 
    [ISRCTN53295293] download pdf: combination | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment antioxidant capsule containing (alpha-tocopherol 200 mg, ascorbic acid 100 mg, pyridoxine hydrochloride 25 mg, zinc sulphate 10 mg, nicotinamide 10 mg, lecithin 9.4 mg, and sodium selenite 0.8 mg)
    Control treatment placebo
    Remarks factorial design of aspirin plus antioxidant compared with aspirin alone, antioxidant alone, and placebo.

    Patients

    Patients patients with diabetes mellitus and asymptomatic peripheral arterial disease
    Inclusion criteria adults of either sex, aged 40 or more, with type 1 or type 2 diabetes who were determined as having asymptomatic peripheral arterial disease as detected by a lower than normal ankle brachial pressure index (<=0.99)
    Exclusion criteria evidence of symptomatic cardiovascular disease; aspirin or antioxidant therapy on a regular basis; peptic ulceration, severe dyspepsia, a bleeding disorder, or intolerance to aspirin; suspected serious physical illness (such as cancer), which might have been expected to curtail life expectancy; psychiatric illness; congenital heart disease; unable to give informed consent
    Baseline characteristics
    Sexe M 43% 
    Age moyen 60 y 

    Method and design

    Randomized effectives 640 / 636 (studied vs. control)
    Design Factorial plan
    Blinding double blind
    Number of centre multicentre
    Geographic area Scotland
    Hypothesis Superiority
    Primary endpoint CV events
    Remarks two hierarchical composite primary end points of death from coronary heart disease or stroke, non-fatal myocardial infarction or stroke, or amputation above the ankle for critical limb ischaemia; and death from coronary heart disease or stroke


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    CHD death, stroke, MI, above ankle amputation 117 / 640 (18,3%) 116 / 636 (18,2%) 1,00 [0,79;1,26]
    Death from coronary heart disease or stroke 42 / 640 (6,6%) 36 / 636 (5,7%) 1,16 [0,75;1,78]
    Death (any cause) 115 / 640 (18,0%) 80 / 636 (12,6%) 1,43 [1,10;1,86]
    Coronary heart disease death 30 / 640 (4,7%) 31 / 636 (4,9%) 0,96 [0,59;1,57]
    Stroke death 12 / 640 (1,9%) 5 / 636 (0,8%) 2,39 [0,85;6,73]
    Non-fatal myocardial infarction 49 / 640 (7,7%) 62 / 636 (9,7%) 0,79 [0,55;1,12]
    Non-fatal stroke 36 / 640 (5,6%) 34 / 636 (5,3%) 1,05 [0,67;1,66]
    Above ankle amputation for critical limb ischaemia 10 / 640 (1,6%) 10 / 636 (1,6%) 0,99 [0,42;2,37]
    Transient ischaemic attack 11 / 640 (1,7%) 23 / 636 (3,6%) 0,48 [0,23;0,97]
    Coronary artery bypass surgery 12 / 640 (1,9%) 14 / 636 (2,2%) 0,85 [0,40;1,83]
    Coronary artery angioplasty 7 / 640 (1,1%) 8 / 636 (1,3%) 0,87 [0,32;2,38]
    Development of angina 69 / 640 (10,8%) 79 / 636 (12,4%) 0,87 [0,64;1,18]
    Peripheral arterial bypass surgery 4 / 640 (0,6%) 8 / 636 (1,3%) 0,50 [0,15;1,64]
    Peripheral arterial angioplasty 12 / 640 (1,9%) 12 / 636 (1,9%) 0,99 [0,45;2,20]
    Development of critical limb ischaemia 22 / 640 (3,4%) 18 / 636 (2,8%) 1,21 [0,66;2,24]
    Development of claudication 97 / 640 (15,2%) 107 / 636 (16,8%) 0,90 [0,70;1,16]
    Malignancy 65 / 640 (10,2%) 56 / 636 (8,8%) 1,15 [0,82;1,62]
    Gastrointestinal bleeding 28 / 640 (4,4%) 31 / 636 (4,9%) 0,90 [0,54;1,48]
    Gastrointestinal symptoms, including dyspepsia 69 / 640 (10,8%) 98 / 636 (15,4%) 0,70 [0,52;0,93]
    Arrhythmia 50 / 640 (7,8%) 52 / 636 (8,2%) 0,96 [0,66;1,39]
    Allergy including skin rash 68 / 640 (10,6%) 68 / 636 (10,7%) 0,99 [0,72;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]

    All cause death

    115 / 640
    80 / 636
    1,43 [1,10;1,86]

    Amputation

    10 / 640
    10 / 636
    classic 0,99 [0,42;2,37]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    All cause death 115 / 640 (18,0%) 80 / 636 (12,6%) 1,43 [1,10;1,86] Death (any cause)  0
    Amputation 10 / 640 (1,6%) 10 / 636 (1,6%) 0,99 [0,42;2,37] Above ankle amputation for critical limb ischaemia  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 (for a follow-up of )
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 17,97% 12,58% 5,4%
    Amputation 1,56% 1,57% -0,01%

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for diabetic patients

    antioxydants in diabetes type 2 for all type of patients

    antioxydants in peripheral vascular diseases for diabetic patients

    antioxydants in peripheral vascular diseases for all type of patients



    Reference(s)

    TrialResults-center ID TRC8776
    Trials register # ISRCTN53295293
    • Belch J, MacCuish A, Campbell I, Cobbe S, Taylor R, Prescott R, Lee R, Bancroft J, MacEwan S, Shepherd J, Macfarlane P, Morris A, Jung R, Kelly C, Connacher A, Peden N, Jamieson A, Matthews D, Leese G, McKnight J, O'Brien I, Semple C, Petrie J, Gordon D, . The prevention of progression of arterial disease and diabetes (POPADAD) trial: factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease.. BMJ 2008 Oct 16;337:a1840
      Pubmed | Hubmed | Fulltext

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