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Related trials

ACCOMPLISH (diabetic subgroup), 2010 - benazepril + amlodipine vs benazepril + hydrochlorothiazide

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IPDM, 2001 - irbesartan vs placebo

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RENAAL, 2001 - losartan vs placebo

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 �g 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 �mol per liter) for men and no more than 1.1 mg per deciliter (97 �mol 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, Br�chner-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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