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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 Irbesartan
    		•  

    IDNT irbesartan study, 2001

    Facebook    pdf : Irbesartan - anti hypertensive agent for hypertension

    Treatments

    Studied treatment Irbesartan 300 mg daily
    Control treatment placebo

    Patients

    Patients hypertensive patients with nephropathy due to type 2 diabetes
    Inclusion criteria age between 30 and 70 years; documented diagnosis of type 2 diabetes mellitus, hypertension (systolic blood pressure of more than 135 mm Hg while sitting, diastolic blood pressure of more than 85 mm Hg while sitting, or documented treatment with antihypertensive agents); proteinuria, with urinary protein excretion of at least 900 mg per 24 hours. Serum creatinine concentration between 1.0 and 3.0 mg per deciliter (88 and 265 �mol per liter) in women and 1.2 and 3.0 mg per deciliter (106 and 265 �mol per liter) in men
    Baseline characteristics
    Glycosylated hemoglobin 8.2% 
    BP (systolic/diastolic) 158/87 
    Female (%) 31% 
    Age 59 y 
    subgroup no 
    hypertension (%) 100% 

    Method and design

    Randomized effectives 579 / 569 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 2.6 years
    Number of centre 210
    Geographic area Worldwide
    Hypothesis Superiority
    Primary endpoint renal death
    Remarks


    Results

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

    renal death

    189 / 579
         222 / 569
         0,84 [0,72;0,98]

    cardiovascular event (fatal and non fatal)

    NA / 579
         NA / 569
         0,91 [0,72;1,15]

    All cause death

    NA / 579
         NA / 569
         0,92 [0,69;1,23]

    microvascular events

    NA / 579
         NA / 569
         0,80 [0,66;0,97]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    renal death 189 / 579 (32,6%) 222 / 569 (39,0%) 0,84 [0,72;0,98]   12500 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 12500: Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz IRenoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.N Engl J Med 2001;345:851-60

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    renal death 32,64% 39,02% -63,7‰

    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
    • Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz I. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.. N Engl J Med 2001;345:851-60
      Pubmed | Hubmed | Fulltext

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