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Related trials

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IPDM, 2001 - irbesartan vs placebo

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IDNT irbesartan, 2001 - Irbesartan vs placebo

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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
  •  

    IPDM study, 2001

    Facebook    pdf : irbesartan - anti hypertensive agent for hypertension

    Treatments

    Studied treatment irbesartan, at a dose of either 150 mg daily or 300 mg daily
    Control treatment placebo
    Remarks 3 arms trial: irbesartan 150 and 300 mg daily, placebo

    Patients

    Patients hypertensive patients with type 2 diabetes and microalbuminuria
    Inclusion criteria hypertension (at least two of three consecutive measurements obtained one week apart during the run-in period of a mean systolic blood pressure of more than 135 mm Hg or a mean diastolic blood pressure of more than 85 mm Hg, or both); age between 30 and 70 years; persistent microalbuminuria (defined as an albumin excretion rate of 20 to 200 ìg per minute in two of three consecutive, sterile, overnight urine samples) and a serum creatinine concentration of no more than 1.5 mg per deciliter (133 ìmol per liter) for men and no more than 1.1 mg per deciliter (97 ìmol per liter) for women
    Exclusion criteria nondiabetic kidney disease; cancer; life-threatening disease with death expected to occur within two years; indication for angiotensin-converting– enzyme (ACE) inhibitors or angiotensin-II–receptor antagonists
    Baseline characteristics
    Duration of diabetes 10 yr 
    Glycosylated hemoglobin 7.1 % 
    BP (systolic/diastolic) 153/90 
    Female (%) 31.3% 
    Age 58.3 y 
    subgroup no 
    hypertension (%) 100% 

    Method and design

    Randomized effectives 389 / 201 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 2 years
    Number of centre 96
    Geographic area Worldwide
    Hypothesis Superiority
    Primary endpoint diabetic nephropathy


    Results

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

    microvascular events

    NA / 590
    NA / 0
    0,30 [0,14;0,64]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.

    Meta-analysis of all similar trials:

    angiotensin renin system blockade in diabetes for all type of patients

    angiotensin-receptor blockers 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
    • Parving HH, Lehnert H, Bröchner-Mortensen J, Gomis R, Andersen S, Arner P. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes.. N Engl J Med 2001;345:870-8
      Pubmed | Hubmed | Fulltext

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