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See also:

  • All diabetes clinical trials
  • All hypertension clinical trials
  • All clinical trials of anti hypertensive agent
  • All clinical trials of ACE inhibitor
  •  

    HOPE (diabetic subgroup) study, 2000

    Facebook    pdf : ACE inhibitor - anti hypertensive agent for hypertension

    Treatments

    Studied treatment ramipril 10 mg once per day orally
    Control treatment placebo
    Remarks factorial design of ramipril and vitamin E

    Patients

    Patients patients with diabetes (sub group), aged 55 years or older, who had a previous cardiovascular event or at least one other cardiovascular risk factor, no clinical proteinuria, heart failure, or low ejection fraction
    Remarks of all 9541 patients in the HOPE trial, 3654 had diabetes
    Baseline characteristics
    BP (systolic/diastolic) 142/80 mmHg 
    Female (%) 37% 
    Age 65.4 y 
    subgroup yes 
    hypertension (%) 56% 

    Method and design

    Randomized effectives 1808 / 1759 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 4.5 years
    Number of centre multicentre
    Geographic area North, South america, Europe
    Hypothesis Superiority
    Primary endpoint CV events


    Results

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

    cardiovascular event (fatal and non fatal)

    277 / 1808
    351 / 1759
    0,77 [0,67;0,89]

    All cause death

    196 / 1808
    248 / 1759
    0,77 [0,65;0,92]

    stroke (fatal and non fatal)

    76 / 1808
    108 / 1759
    0,68 [0,51;0,91]

    myocardial infarction (fatal and non fatal)

    112 / 1808
    172 / 1759
    0,63 [0,50;0,80]

    microvascular events

    273 / 1808
    312 / 1759
    0,85 [0,73;0,99]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    cardiovascular event (fatal and non fatal) 277 / 1808 (15,3%) 351 / 1759 (20,0%) 0,77 [0,67;0,89]   7238 
    All cause death 196 / 1808 (10,8%) 248 / 1759 (14,1%) 0,77 [0,65;0,92]   7238 
    stroke (fatal and non fatal) 76 / 1808 (4,2%) 108 / 1759 (6,1%) 0,68 [0,51;0,91]   7238 
    myocardial infarction (fatal and non fatal) 112 / 1808 (6,2%) 172 / 1759 (9,8%) 0,63 [0,50;0,80]   7238 
    microvascular events 273 / 1808 (15,1%) 312 / 1759 (17,7%) 0,85 [0,73;0,99] Dialysis, over nephropathy, laser, dialysis  7238 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7238: Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Heart Outcomes Prevention Evaluation Study Investigators.Lancet 2000;355:253-9

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    cardiovascular event (fatal and non fatal) 15,32% 19,95% -46,3‰
    All cause death 10,84% 14,10% -32,6‰
    stroke (fatal and non fatal) 4,20% 6,14% -19,4‰
    myocardial infarction (fatal and non fatal) 6,19% 9,78% -35,8‰
    microvascular events 15,10% 17,74% -26,4‰

    Meta-analysis of all similar trials:

    angiotensin renin system blockade in diabetes for all type of patients

    anti hypertensive agent in diabetes for type1 and 2 diabetic patients with hypertension

    anti hypertensive agent in hypertension for diabetic patients



    Reference(s)

    Trials register # NA
    • . Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Heart Outcomes Prevention Evaluation Study Investigators.. Lancet 2000;355:253-9
      Pubmed | Hubmed | Fulltext
    • Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators.. N Engl J Med 2000;342:145-53
      Pubmed | Hubmed | Fulltext

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