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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 nisoldipine
    		•  

    ABCD study, 1998

    Facebook    pdf : nisoldipine - anti hypertensive agent for hypertension

    Treatments

    Studied treatment nisoldipine (long acting)
    10 mg per day, with increases to 20, 40, and 60 mg per day
    Control treatment enalapril
    5 mg per day, with increases to 10, 20, and 40 mg per day
    Concomittant treatment -

    Patients

    Patients patients with non-insulin-dependent diabetes and hypertension
    Inclusion criteria hypertensive patients with diabetes (NIDDM) ages: 40 to 74y; NIDDM according criteria of the WHO report of 1985; DBP>80 mmHg; no hypertensive drug at the time of randomization
    Exclusion criteria allergy to dihydropyridine calcium antagonist or ACE inhibitors; stroke or MI within the previous 6mo; CABG within 3mo; unstable angina pectoris within 6mo; heart failure stade III or IV, etc.
    Baseline characteristics
    Duration of diabetes 8.5 y 
    Duration of hypertension 12 y 
    Glycosylated hemoglobin 11.6% 
    BP (systolic/diastolic) 155/98 
    Female (%) 33% 
    Age 57 y 
    subgroup no 
    hypertension (%) 100% 

    Method and design

    Randomized effectives 235 / 235 (studied vs. control)
    Design Factorial plan
    Blinding Double blind
    Follow-up duration 5 y
    Lost to follow-up ND
    Number of centre single center
    Geographic area USA
    Hypothesis Superiority
    Primary endpoint 24-hour creatinine clearance
    Withdrawals (T1/T0) ND /


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Fatal or nonfatal myocardial infarction 25 / 235 (10,6%) 5 / 235 (2,1%) 5,00 [1,95;12,84]
    Nonfatal myocardial infarction 22 / 235 (9,4%) 5 / 235 (2,1%) 4,40 [1,69;11,42]
    Cerebrovascular accident 11 / 235 (4,7%) 7 / 235 (3,0%) 1,57 [0,62;3,98]
    Congestive heart failure 6 / 235 (2,6%) 5 / 235 (2,1%) 1,20 [0,37;3,88]
    Death from cardiovascular causes 10 / 235 (4,3%) 5 / 235 (2,1%) 2,00 [0,69;5,76]
    Death from any cause 17 / 235 (7,2%) 13 / 235 (5,5%) 1,31 [0,65;2,63]

    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]

    cardiovascular event (fatal and non fatal)

    25 / 235
         5 / 235
         classic 5,00 [1,95;12,84]

    Cardiovascular death

    10 / 235
         5 / 235
         classic 2,00 [0,69;5,76]

    All cause death

    17 / 235
         13 / 235
         classic 1,31 [0,65;2,63]

    stroke (fatal and non fatal)

    11 / 235
         7 / 235
         classic 1,57 [0,62;3,98]

    myocardial infarction (fatal and non fatal)

    25 / 235
         5 / 235
         classic 5,00 [1,95;12,84]     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) 25 / 235 (10,6%) 5 / 235 (2,1%) 5,00 [1,95;12,84]    
    Cardiovascular death 10 / 235 (4,3%) 5 / 235 (2,1%) 2,00 [0,69;5,76]   380 
    All cause death 17 / 235 (7,2%) 13 / 235 (5,5%) 1,31 [0,65;2,63]    
    stroke (fatal and non fatal) 11 / 235 (4,7%) 7 / 235 (3,0%) 1,57 [0,62;3,98]    
    myocardial infarction (fatal and non fatal) 25 / 235 (10,6%) 5 / 235 (2,1%) 5,00 [1,95;12,84]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 380: Estacio RO, Jeffers BW, Hiatt WR, Biggerstaff SL, Gifford N, Schrier RWThe effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension.N Engl J Med 1998;338:645-52

    • 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) 10,64% 2,13% 8,5%
    Cardiovascular death 4,26% 2,13% 2,1%
    All cause death 7,23% 5,53% 1,7%
    stroke (fatal and non fatal) 4,68% 2,98% 1,7%
    myocardial infarction (fatal and non fatal) 10,64% 2,13% 8,5%

    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
    • Estacio RO, Jeffers BW, Hiatt WR, Biggerstaff SL, Gifford N, Schrier RW. The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension.. N Engl J Med 1998;338:645-52
      Pubmed | Hubmed | Fulltext

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