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Related trials

OSCAR, 2011 - olmesartan 40 mg vs olmesartan 20 mg plus a calcium-channel blocker

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HIJ-CREATE, 2009 - candesartan vs conventional treatment

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ACCOMPLISH, 2008 - amlodipine plus benazepril vs hydrochlorothiazide plus benazepril

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ONTARGET/Tel+Ram, 2008 - Telmisartan + ramipril vs Ramipril

ONTARGET (association vs telmisartan), 2008 - telmisartan + ramipril vs telmisartan

Andersen, 2008 - aliskiren vs ramipril

VALIDD, 2007 - valsartan vs no valsartan

TROPHY, 2006 - candesartan vs placebo



See also:

  • All miscellaneous clinical trials
  • All patients at high risk for cardiovascular events clinical trials
  • All hypertension clinical trials
  • All clinical trials of anti hypertensive agent
  • All clinical trials of valsartan
  •  

    VALUE study, 2004

    [NCT00129233] download pdf: valsartan | anti hypertensive agent for hypertension

    Treatments

    Studied treatment valsartan based regimen
    Control treatment amlodipine based regimen

    Patients

    Patients patients, aged 50 years or older with treated or untreated hypertension and high risk of cardiac events
    Inclusion criteria men or women of any racial background, 50 years of age and older, and presence of cardiovascular risk factors or disease according to an algorithm based on age and sex. The qualifying risk factors were male sex, age older than 50 years, verified diabetes mellitus, current smoking, high total cholesterol, left ventricular hypertrophy by electrocardiogram, proteinuria on dipstick and raised serum creatinine between 150 and 265 µmol/L. The qualifying diseases were verified coronary disease, cerebrovascular disease or peripheral arterial occlusive disease, or left ventricular hypertrophy with strain pattern.
    Exclusion criteria renal artery stenosis, pregnancy, acute myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass graft within the past 3 months, clinically relevant valvular disease, cerebrovascular accident in the past 3 months, severe hepatic disease, severe chronic renal failure, congestive heart failure requiring ACE inhibitor therapy, patients on monotherapy with blockers for both coronary artery disease and hypertension
    Baseline characteristics
    Age (yr) 67.25y 
    female (%) 42% 
    SBP (mmHg) 154.8 
    DBP (mmHg) 87.6 
    BMI 28.65 
    Diabetic (%) 32% 

    Method and design

    Randomized effectives 7649 / 7596 (studied vs. control)
    Design Parallel groups
    Blinding Double blind
    Follow-up duration 4.2 y (mean)
    Lost to follow-up 71 (0.47%)
    Number of centre multicentre
    Geographic area 31 countries
    Hypothesis Superiority
    Primary endpoint cardiac event


    Results

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

    Cancer

    669 / 7622
    782 / 7576
    0,85 [0,77;0,94]

    Cardiovascular death

    304 / 7649
    304 / 7596
    0,99 [0,85;1,16]

    stroke (fatal and non fatal)

    322 / 7649
    281 / 7596
    1,14 [0,97;1,33]

    myocardial infarction (fatal and non fatal)

    369 / 7649
    313 / 7596
    1,17 [1,01;1,36]

    Heart failure

    354 / 7649
    400 / 7596
    0,88 [0,76;1,01]

    Diabetes onset

    690 / 7649
    845 / 7596
    0,81 [0,74;0,89]

    All cause death

    841 / 7649
    818 / 7596
    1,02 [0,93;1,12]

    cardiovascular events

    810 / 7649
    789 / 7596
    1,02 [0,93;1,12]

    Coronary event

    810 / 7649
    789 / 7596
    1,02 [0,93;1,12]

    cardiac death

    304 / 7649
    304 / 7596
    0,99 [0,85;1,16]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Cancer 669 / 7622 (8,8%) 782 / 7576 (10,3%) 0,85 [0,77;0,94]   14458
    Cardiovascular death 304 / 7649 (4,0%) 304 / 7596 (4,0%) 0,99 [0,85;1,16] cardiac mortality  7362
    stroke (fatal and non fatal) 322 / 7649 (4,2%) 281 / 7596 (3,7%) 1,14 [0,97;1,33]   0
    myocardial infarction (fatal and non fatal) 369 / 7649 (4,8%) 313 / 7596 (4,1%) 1,17 [1,01;1,36]   0
    Heart failure 354 / 7649 (4,6%) 400 / 7596 (5,3%) 0,88 [0,76;1,01]   14530
    Diabetes onset 690 / 7649 (9,0%) 845 / 7596 (11,1%) 0,81 [0,74;0,89]   0
    All cause death 841 / 7649 (11,0%) 818 / 7596 (10,8%) 1,02 [0,93;1,12]   0
    cardiovascular events 810 / 7649 (10,6%) 789 / 7596 (10,4%) 1,02 [0,93;1,12]  
    cardiac death 304 / 7649 (4,0%) 304 / 7596 (4,0%) 0,99 [0,85;1,16]  
    Coronary event 810 / 7649 (10,6%) 789 / 7596 (10,4%) 1,02 [0,93;1,12]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7362: Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti AOutcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial.Lancet 2004 Jun 19;363:2022-31
  • 0:
  • 14530: Bangalore S, Kumar S, Wetterslev J, Messerli FHAngiotensin receptor blockers and risk of myocardial infarction: meta-analyses and trial sequential analyses of 147 020 patients from randomised trials.BMJ 2011 Apr 26;342:d2234
  • 14458: Effects of telmisartan, irbesartan, valsartan, candesartan, and losartan on cancers in 15 trials enrolling 138 769 individuals.J Hypertens 2011;29:623-635

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Cancer 8,78% 10,32% -15,4‰
    Cardiovascular death 3,97% 4,00% -0,3‰
    stroke (fatal and non fatal) 4,21% 3,70% 5,1‰
    myocardial infarction (fatal and non fatal) 4,82% 4,12% 7,0‰
    Heart failure 4,63% 5,27% -6,4‰
    Diabetes onset 9,02% 11,12% -21,0‰
    All cause death 10,99% 10,77% 2,3‰
    cardiovascular events 10,59% 10,39% 2,0‰
    cardiac death 3,97% 4,00% -0,3‰
    Coronary event 10,59% 10,39% 2,0‰

    Meta-analysis of all similar trials:

    angiotensin-receptor blockers in hypertension for all diseases requiring ACEi (HF, CHD, HT,...)

    angiotensin-receptor blockers in miscellaneous for all type of patients

    angiotensin-receptor blockers in patients at high risk for cardiovascular events for all type of patients

    anti hypertensive agent in hypertension for diabetic patients

    anti hypertensive agent in hypertension for all type of patient



    Reference(s)

    Trials register # NCT00129233
    • Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti A. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial.. Lancet 2004 Jun 19;363:2022-31
      Pubmed | Hubmed | Fulltext

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