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Related trials

ROADMAP, 2010 - olmesartan vs placebo

Ruilope, 2010 - LCZ696 vs placebo

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VALIDD, 2007 - valsartan vs no valsartan

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SCOPE, 2003 - candesartan vs placebo

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CHARM-Added, 2003 - candesartan+ACE inhibitor vs ACE inhibitor only

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See also:

  • All miscellaneous clinical trials
  • All diabetes clinical trials
  • All clinical trials of anti hypertensive agent
  • All clinical trials of olmesartan
    		•  

    ROADMAP study, 2010

    [NCT00185159] Facebook    pdf : olmesartan - anti hypertensive agent for diabetes

    Treatments

    Studied treatment olmesartan at 40 mg/day
    Control treatment placebo

    Patients

    Patients patients with diabetes and at least one additional cardiovascular risk factor, but no evidence of renal dysfunction
    Inclusion criteria diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL; at least one of the following cardiovascular risk factors: total cholesterol greater than 200 mg/dL or statin treatment, high density lipoprotein (HDL) less than 40 mg/dL, triglycerides greater than 150 mg/dL and less than 400 mg/dL, blood pressure greater than or equal to 130/80 mmHg,body mass index (BMI) greater than 28 kg/m2, waist circumference greater than 102 cm for men and greater than 88 cm for women, smoking of more than 5 cigarettes a day; normoalbuminuria at screening

    Method and design

    Randomized effectives 2232 / 2215 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 3.2 y
    Geographic area Europe
    Primary endpoint microalbuminuria


    Results

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

    Cardiovascular death

    15 / 2232
         3 / 2215
         classic 4,96 [1,44;17,12]

    Non fatal stroke

    14 / 2232
         8 / 2215
         classic 1,74 [0,73;4,13]

    All cause death

    26 / 2232
         15 / 2215
         classic 1,72 [0,91;3,24]

    Non fatal MI

    17 / 2232
         26 / 2215
         0,65 [0,35;1,19]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Cardiovascular death 15 / 2232 (0,7%) 3 / 2215 (0,1%) 4,96 [1,44;17,12]    
    All cause death 26 / 2232 (1,2%) 15 / 2215 (0,7%) 1,72 [0,91;3,24]    
    Non fatal MI 17 / 2232 (0,8%) 26 / 2215 (1,2%) 0,65 [0,35;1,19]    
    Non fatal stroke 14 / 2232 (0,6%) 8 / 2215 (0,4%) 1,74 [0,73;4,13]    
    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.
    Cardiovascular death 6,72‰ 1,35‰ 5,4‰
    All cause death 1,16% 6,77‰ 4,9‰
    Non fatal MI 7,62‰ 1,17% -4,1‰
    Non fatal stroke 6,27‰ 3,61‰ 2,7‰

    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

    angiotensin-receptor blockers in miscellaneous for all type of patients

    anti hypertensive agent in diabetes for patients with or without hypertension



    Reference(s)

    Trials register # NCT00185159
    • Ritz E, Viberti GC, Ruilope LM, Rabelink AJ, Izzo JL Jr, Katayama S, Ito S, Mimran A, Menne J, Rump LC, Januszewicz A, Haller H. Determinants of urinary albumin excretion within the normal range in patients with type 2 diabetes: the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study.. Diabetologia 2010;53:49-57 - 10.1007/s00125-009-1577-3
      Pubmed | Hubmed | Fulltext

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