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See also:

  • All hypertension clinical trials
  • All cardiovascular prevention clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of aspirin
    		•  

    HOT study, 1998

    Treatments

    Studied treatment aspirin 75 mg daily
    Control treatment placebo
    Remarks factorial design: 3 BP target

    Patients

    Patients patients aged 50-80 with hypertension and diastolic blood pressure between 100 mmHG and 115 mmHG

    Method and design

    Randomized effectives 9399 / 9391 (studied vs. control)
    Design Factorial plan
    Blinding Double blind
    Follow-up duration mean 3.8 y (range 3.3-4.9y)
    Number of centre multicenter
    Geographic area Europe, North and South America, and Asia
    Hypothesis Superiority
    Primary endpoint non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death


    Results

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

    Coronary event

    82 / 9399
         127 / 9391
         0,65 [0,49;0,85]

    stroke (fatal and non fatal)

    146 / 9399
         148 / 9391
         0,99 [0,79;1,24]

    Haemmorhagic stroke

    14 / 9399
         15 / 9391
         0,93 [0,45;1,93]

    Cardiovascular events

    315 / 9399
         368 / 9391
         0,86 [0,74;0,99]

    Major gastrointestinal bleeding

    77 / 9399
         37 / 9391
         classic 2,08 [1,41;3,07]

    Non fatal MI

    68 / 9399
         114 / 9391
         0,60 [0,44;0,80]

    Coronary death

    14 / 9399
         14 / 9391
         classic 1,00 [0,48;2,09]

    All cause death

    284 / 9399
         305 / 9391
         0,93 [0,79;1,09]

    Gastrointestinal Bleeding

    107 / 9399
         55 / 9391
         classic 1,94 [1,41;2,69]

    myocardial infarction (fatal and non fatal)

    82 / 9399
         127 / 9391
         0,65 [0,49;0,85]

    Cardiovascular death

    133 / 9399
         140 / 9391
         0,95 [0,75;1,20]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 82 / 9399 (0,9%) 127 / 9391 (1,4%) 0,65 [0,49;0,85]    
    stroke (fatal and non fatal) 146 / 9399 (1,6%) 148 / 9391 (1,6%) 0,99 [0,79;1,24]    
    Haemmorhagic stroke 14 / 9399 (0,1%) 15 / 9391 (0,2%) 0,93 [0,45;1,93]    
    Cardiovascular events 315 / 9399 (3,4%) 368 / 9391 (3,9%) 0,86 [0,74;0,99]    
    Non fatal MI 68 / 9399 (0,7%) 114 / 9391 (1,2%) 0,60 [0,44;0,80]   10916 
    Coronary death 14 / 9399 (0,1%) 14 / 9391 (0,1%) 1,00 [0,48;2,09]    
    All cause death 284 / 9399 (3,0%) 305 / 9391 (3,2%) 0,93 [0,79;1,09]    
    Gastrointestinal Bleeding 107 / 9399 (1,1%) 55 / 9391 (0,6%) 1,94 [1,41;2,69]   3354 
    myocardial infarction (fatal and non fatal) 82 / 9399 (0,9%) 127 / 9391 (1,4%) 0,65 [0,49;0,85]    
    Major gastrointestinal bleeding 77 / 9399 (0,8%) 37 / 9391 (0,4%) 2,08 [1,41;3,07]   3354 
    Cardiovascular death 133 / 9399 (1,4%) 140 / 9391 (1,5%) 0,95 [0,75;1,20]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 3354: Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, Menard J, Rahn KH, Wedel H, Westerling SEffects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group.Lancet 1998 Jun 13;351:1755-62
  • 10916: Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti AAspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials.Lancet 2009 May 30;373:1849-60

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 8,72‰ 1,35% -4,8‰
    stroke (fatal and non fatal) 1,55% 1,58% -0,2‰
    Haemmorhagic stroke 1,49‰ 1,60‰ -0,1‰
    Cardiovascular events 3,35% 3,92% -5,7‰
    Non fatal MI 7,23‰ 1,21% -4,9‰
    Coronary death 1,49‰ 1,49‰ -0,0‰
    All cause death 3,02% 3,25% -2,3‰
    Gastrointestinal Bleeding 1,14% 5,86‰ 5,5‰
    myocardial infarction (fatal and non fatal) 8,72‰ 1,35% -4,8‰
    Major gastrointestinal bleeding 8,19‰ 3,94‰ 4,3‰
    Cardiovascular death 1,42% 1,49% -0,8‰


    Reference(s)

    Trials register # NA
    • Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, Menard J, Rahn KH, Wedel H, Westerling S. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group.. Lancet 1998 Jun 13;351:1755-62
      Pubmed | Hubmed | Fulltext

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