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Systematic review and meta-analysis

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

diabetes - anti hypertensive agent - type1 and 2 diabetic patients with hypertension

hypertension - anti hypertensive agent - diabetic patients


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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 nitrendipine
  •  

    Syst-Eur (diabetic subgroup) study, 1999

    Facebook    pdf : nitrendipine - anti hypertensive agent for hypertension

    Treatments

    Studied treatment Calcium-channel blocker
    nitrendipine (10 to 40 mg per day) with the possible addition or substitution of enalapril (5 to 20 mg per day) or hydrochlorothiazide (12.5 to 25 mg per day) or both, titrated to reduce the systolic blood pressure by at least 20 mm Hg and to less than 150 mm Hg
    Control treatment placebo

    Patients

    Patients subgroup of diabetic patients, age, >=60 years) with systolic blood pressure of 160 to 219 mm Hg and diastolic pressure below 95 mm Hg
    Inclusion criteria 60 years of age or older; sitting systolic blood pressure ranging from 160 to 219 mm Hg systolic and diastolic blood pressure below 95 mm Hg with standing systolic pressure of 140 mm Hg or higher
    Remarks of all 4695 patients included in the study, 492 had diabetes
    Baseline characteristics
    BP (systolic/diastolic) 175.3/84.5 
    Female (%) NA 
    Age NA 
    subgroup yes 

    Method and design

    Randomized effectives 252 / 240 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 2 years
    Hypothesis Superiority
    Primary endpoint persisting neurologic deficit


    Results

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

    cardiovascular event (fatal and non fatal)

    13 / 252
    31 / 240
    0,40 [0,21;0,74]

    Cardiovascular death

    5 / 252
    16 / 240
    0,30 [0,11;0,80]

    All cause death

    16 / 252
    26 / 240
    0,59 [0,32;1,06]

    stroke (fatal and non fatal)

    5 / 252
    15 / 240
    0,32 [0,12;0,86]

    myocardial infarction (fatal and non fatal)

    7 / 252
    15 / 240
    0,44 [0,18;1,07]
    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) 13 / 252 (5,2%) 31 / 240 (12,9%) 0,40 [0,21;0,74]   7237 
    Cardiovascular death 5 / 252 (2,0%) 16 / 240 (6,7%) 0,30 [0,11;0,80]   7237 
    All cause death 16 / 252 (6,3%) 26 / 240 (10,8%) 0,59 [0,32;1,06]   7237 
    stroke (fatal and non fatal) 5 / 252 (2,0%) 15 / 240 (6,3%) 0,32 [0,12;0,86]   7237 
    myocardial infarction (fatal and non fatal) 7 / 252 (2,8%) 15 / 240 (6,3%) 0,44 [0,18;1,07] cardiac events  7237 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7237: Tuomilehto J, Rastenyte D, Birkenhäger WH, Thijs L, Antikainen R, Bulpitt CJ, Fletcher AE, Forette F, Goldhaber A, Palatini P, Sarti C, Fagard REffects of calcium-channel blockade in older patients with diabetes and systolic hypertension. Systolic Hypertension in Europe Trial Investigators.N Engl J Med 1999;340:677-84

  • 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) 5,16% 12,92% -77,6‰
    Cardiovascular death 1,98% 6,67% -46,8‰
    All cause death 6,35% 10,83% -44,8‰
    stroke (fatal and non fatal) 1,98% 6,25% -42,7‰
    myocardial infarction (fatal and non fatal) 2,78% 6,25% -34,7‰

    Meta-analysis of all similar trials:

    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
    • Tuomilehto J, Rastenyte D, Birkenhäger WH, Thijs L, Antikainen R, Bulpitt CJ, Fletcher AE, Forette F, Goldhaber A, Palatini P, Sarti C, Fagard R. Effects of calcium-channel blockade in older patients with diabetes and systolic hypertension. Systolic Hypertension in Europe Trial Investigators.. N Engl J Med 1999;340:677-84
      Pubmed | Hubmed | Fulltext

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