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RENAAL, 2001 - losartan 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 losartan
    		•  

    RENAAL study, 2001

    Facebook    pdf : losartan - anti hypertensive agent for hypertension

    Treatments

    Studied treatment losartan 50 to 100 mg once daily
    Control treatment placebo
    Concomittant treatment in addition to conventional antihypertensive treatment (calcium-channel antagonists, diuretics, alpha-blockers, beta-blockers, and centrally acting agents)

    Patients

    Patients patients with type 2 diabetes and nephropathy
    Inclusion criteria age between 31 to 70 years; ratio of urinary albumin (measured in milligrams per liter) to urinary creatinine (measured in grams per liter) from a first morning specimen of at least 300 (or a rate of urinary protein excretion of at least 0.5 g per day) and serum creatinine values between 1.3 and 3.0 mg per deciliter (115 and 265 ìmol per liter), with a lower limit of 1.5 mg per deciliter (133 ìmol per liter) for male patients weighing more than 60 kg
    Exclusion criteria type 1 diabetes or nondiabetic renal disease; myocardial infarction; coronary- artery bypass grafting within the previous month; cerebrovascular accident; percutaneous transluminal coronary angioplasty within the previous six months; transient ischemic attack within the previous year; history of heart failure
    Baseline characteristics
    Glycosylated hemoglobin 8.5% 
    BP (systolic/diastolic) 152/82 
    Female (%) 36.8% 
    Age 60 y 
    subgroup no 
    hypertension (%) 93% 

    Method and design

    Randomized effectives 751 / 762 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 3.4 y
    Number of centre 250
    Geographic area America, Europe, Asia
    Hypothesis Superiority
    Primary endpoint doubling of the creatinine, end-stage renal disease, death


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    doubling of the serum creatinine concentration, end-stage renal disease, death 327 / 751 (43,5%) 359 / 762 (47,1%) 0,92 [0,83;1,03]
    Doubling of serum creatinine concentration 162 / 751 (21,6%) 198 / 762 (26,0%) 0,83 [0,69;1,00]
    End-stage renal disease 147 / 751 (19,6%) 194 / 762 (25,5%) 0,77 [0,64;0,93]
    Death 158 / 751 (21,0%) 155 / 762 (20,3%) 1,03 [0,85;1,26]
    End-stage renal disease or death 255 / 751 (34,0%) 300 / 762 (39,4%) 0,86 [0,75;0,99]
    Doubling of serum creatinine concentration and end-stage renal disease 226 / 751 (30,1%) 263 / 762 (34,5%) 0,87 [0,75;1,01]

    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]

    renal death

    327 / 751
         359 / 762
         0,92 [0,83;1,03]

    All cause death

    NA / 1513
         NA / 762
         1,02 [0,80;1,30]

    microvascular events

    NA / 1513
         NA / 762
         0,79 [0,66;0,95]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    renal death 327 / 751 (43,5%) 359 / 762 (47,1%) 0,92 [0,83;1,03] doubling of the serum creatinine concentration, end-stage renal disease, death   
    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.
    renal death 43,54% 47,11% -35,7‰

    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 hypertension for diabetic patients



    Reference(s)

    Trials register # NA
    • Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, Remuzzi G, Snapinn SM, Zhang Z, Shahinfar S. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy.. N Engl J Med 2001;345:861-9
      Pubmed | Hubmed | Fulltext

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