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See also:

  • All hypertension clinical trials
  • All clinical trials of renin inhibitor
  • All clinical trials of aliskiren
    		•  

    AVOID study, 2008

    [NCT00097955] Facebook    pdf : aliskiren - anti hypertensive agent for hypertension

    Treatments

    Studied treatment aliskiren (150 mg daily for 3 months, followed by an increase in dosage to 300 mg daily for another 3 months
    Control treatment placebo
    Concomittant treatment maximal recommended dose of losartan (100 mg daily) and optimal antihypertensive therapy

    Patients

    Patients patients with hypertension and type 2 diabetes with nephropathy
    Inclusion criteria hypertension; 18 to 85 years of age;type 2 diabetes and nephropathy defined by an early-morning urinary albumin-to-creatinine ratio of >300 mg/g or >200 mg/g in case of therapy targeted at blockade of the renin −angiotensin−aldosterone system
    Exclusion criteria nondiabetic kidney disease; urinary albumin-to-creatinine ratio of moret han 3500 mg per gram; estimated glomerular filtration rate of less than 30 ml per minute per 1.73 m2; chronic urinary- tract infection; serum potassium level greater than 5.1 mmol per liter; severe hypertension, or major cardiovascular disease within the previous 6 months

    Method and design

    Randomized effectives 301 / 298 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 6 months
    Lost to follow-up n=1
    Number of centre 150
    Geographic area 15 countries
    Primary endpoint ratio of albumin to creatinine


    Results

    Detailled results with data usable for meta-analysis are not reported in the published paper but only qualitative/descriptive content.

  • reduction in mean urinary albumin-to-creatinine
  • ratio by 20%, 95%CI 9 to 30 (p

    • 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]

    any adverse event

    201 / 301
         200 / 298
         0,99 [0,89;1,11]

    All cause death

    0 / 301
         2 / 298
         classic 0,11 [0,00;6,83]

    Serious adverse event

    27 / 301
         28 / 298
         0,95 [0,58;1,58]

    Adverse events leading to treatment discontinuation

    17 / 301
         19 / 298
         0,89 [0,47;1,67]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Serious adverse event 27 / 301 (9,0%) 28 / 298 (9,4%) 0,95 [0,58;1,58]   10615 
    Adverse events leading to treatment discontinuation 17 / 301 (5,6%) 19 / 298 (6,4%) 0,89 [0,47;1,67]   10615 
    any adverse event 201 / 301 (66,8%) 200 / 298 (67,1%) 0,99 [0,89;1,11]   10615 
    All cause death 0 / 301 (0,2%) 2 / 298 (0,7%) 0,25 [0,01;5,47]   10615 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 10615: Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NKAliskiren combined with losartan in type 2 diabetes and nephropathy.N Engl J Med 2008;358:2433-46

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Serious adverse event 8,97% 9,40% -4,3‰
    Adverse events leading to treatment discontinuation 5,65% 6,38% -7,3‰
    any adverse event 66,78% 67,11% -3,4‰

    Meta-analysis of all similar trials:

    anti hypertensive agent in hypertension for diabetic patients

    anti hypertensive agent in hypertension for all type of patient

    anti hypertensive agent in hypertension for nephropathy

    renin inhibitor in hypertension for all type of patients

    renin inhibitor in hypertension for diabetic patients



    Reference(s)

    Trials register # NCT00097955
    • Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NK. Aliskiren combined with losartan in type 2 diabetes and nephropathy.. N Engl J Med 2008;358:2433-46
      Pubmed | Hubmed | Fulltext

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