Trial-Results center  
Clinical trial results database in Heart and vessels Feedback    Home


Related trials

IMPROVE-IT, 2014 - ezetimibe vs control

AIM-HIGH, 2011 - niacin vs placebo (on top statin)

ACCORD lipid, 2010 - fenofibrate vs placebo (on top simvastatine)

ARBITER-HALTS 6, 2010 - ezetimibe vs niacin

SEARCH, 2010 - simvastatin high dose vs simvastatin

SHARP, 2010 - ezetimibe+simvastatin vs placebo

Oxford Niaspan Study, 2009 - niacin vs placebo (on top statin)

Emmerich, 2009 - etofibrate vs placebo

ARBITER 6-HALTS (niacin vs ezetimibe), 2009 - niacin vs ezetimibe

ARBITER 2, 2009 - niacin vs placebo (on top statin)

GISSI-HF rosuvastatine, 2008 - rosuvastatin vs placebo

SANDS, 2008 - aggressive treatment vs standard teatment

JUPITER, 2008 - rosuvastatin vs placebo

Tuttle, 2008 - low fat diet vs mediterranean-style diet

SAGE, 2007 - atorvastatin high dose vs pravastatin

METEOR, 2007 - rosuvastatin vs placebo

Krum, 2007 - rosuvastatin vs placebo

CORONA, 2007 - rosuvastatin vs placebo

Patti et al., 2006 - preoperative atorvastatin vs placebo

ASPEN, 2006 - atorvastatin vs placebo

Chello et al., 2006 - preoperative atorvastatin vs placebo

ASPEN (primary prevention sub group), 2006 - atorvastatin vs placebo

SPARCL, 2006 - atorvastatin vs placebo

MEGA, 2006 - pravastatin vs control

Strey, 2005 - atorvastatin vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of rosuvastatin
  •  
     JUPITER study, 2008 TRC6751 
    [NCT00239681] download pdf: rosuvastatin | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment rosuvastatin 20 mg daily
    Control treatment placebo

    Patients

    Patients apparently healthy individuals with low LDL-cholesterol levels of less than 130 mg per deciliter but elevated C-reactive-protein (high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher)
    Inclusion criteria males aged 50 years and older and females aged 60 years and older with no history of MI, stroke, or arterial revascularisation; LDL cholesterol level of less than 130 mg per deciliter (3.4 mmol per liter); high-sensitivity C-reactive protein level of 2.0 mg per liter or more; triglyceride level of less than 500 mg per deciliter (5.6 mmol per liter)
    Exclusion criteria previous or current use of lipid-lowering therapy, current use of postmenopausal hormone-replacement therapy, evidence of hepatic dysfunction (an alanine aminotransferase level that was more than twice the upper limit of the normal range), a creatine kinase level that was more than three times the upper limit of the normal range, a creatinine level that was higher than 2.0 mg per deciliter (176.8 ìmol per liter), diabetes, uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg), cancer within 5 years before enrollment (with the exception of basal-cell or squamous-cell carcinoma of the skin), uncontrolled hypothyroidism (a thyroid-stimulating hormone level that was more than 1.5 times the upper limit of the normal range), and a recent history of alcohol or drug abuse or another medical condition that might compromise safety or the successful completion of the study
    Baseline characteristics
    Women (%) 38% 
    Total cholesterol (mmol/l) 185 mg/dl 
    LDL (mmol/l) 108 mg/dl 
    HDL (mmol/l) 49 mg/dl 
    Triglycerides (mg/dl) 118 mg/dl 
    BMI (kg/m2) 28.3 

    Method and design

    Randomized effectives 8901 / 8901 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration median 1.9 year
    Premature discontinuation Premature discontinuation for efficacy
    Number of centre 1200
    Geographic area 26 countries
    Hypothesis Superiority
    Primary endpoint MI, stroke, arterial revascularization, hospitalization for unstable angina, cardiovascular death


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Primary end point 142 / 8901 (1,6%) 251 / 8901 (2,8%) 0,57 [0,46;0,69]
    Nonfatal myocardial infarction 22 / 8901 (0,2%) 62 / 8901 (0,7%) 0,35 [0,22;0,58]
    Any myocardial infarction 31 / 8901 (0,3%) 68 / 8901 (0,8%) 0,46 [0,30;0,70]
    Nonfatal stroke 30 / 8901 (0,3%) 58 / 8901 (0,7%) 0,52 [0,33;0,80]
    Any stroke 33 / 8901 (0,4%) 64 / 8901 (0,7%) 0,52 [0,34;0,78]
    Arterial revascularization 71 / 8901 (0,8%) 131 / 8901 (1,5%) 0,54 [0,41;0,72]
    Hospitalization for unstable angina 16 / 8901 (0,2%) 27 / 8901 (0,3%) 0,59 [0,32;1,10]
    Arterial revascularization or hospitalization for unstable angina 76 / 8901 (0,9%) 143 / 8901 (1,6%) 0,53 [0,40;0,70]
    Myocardial infarction, stroke, or confirmed death from cardiovascular causes 83 / 8901 (0,9%) 157 / 8901 (1,8%) 0,53 [0,41;0,69]
    Death on known date 190 / 8901 (2,1%) 235 / 8901 (2,6%) 0,81 [0,67;0,98]
    Any death 198 / 8901 (2,2%) 247 / 8901 (2,8%) 0,80 [0,67;0,96]

    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]

    Coronary event

    31 / 8901
    68 / 8901
    0,46 [0,30;0,70]

    All cause death

    198 / 8901
    247 / 8901
    0,80 [0,67;0,96]

    cardiovascular events

    83 / 8901
    157 / 8901
    0,53 [0,41;0,69]

    Venous thromboembolism

    34 / 8901
    60 / 8901
    0,57 [0,37;0,86]

    Fatal stroke

    3 / 8901
    6 / 8901
    0,50 [0,13;2,00]

    Haemmorhagic stroke

    6 / 8901
    9 / 8901
    0,67 [0,24;1,87]

    new-onset diabetes

    270 / 8901
    216 / 8901
    1,25 [1,05;1,49]

    stroke (fatal and non fatal)

    33 / 8901
    64 / 8901
    0,52 [0,34;0,78]

    Non fatal MI

    22 / 8901
    62 / 8901
    0,35 [0,22;0,58]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 31 / 8901 (0,3%) 68 / 8901 (0,8%) 0,46 [0,30;0,70] Any myocardial infarction 
    All cause death 198 / 8901 (2,2%) 247 / 8901 (2,8%) 0,80 [0,67;0,96] Any death 
    cardiovascular events 83 / 8901 (0,9%) 157 / 8901 (1,8%) 0,53 [0,41;0,69] Myocardial infarction, stroke, or confirmed death from cardiovascular causes 
    Venous thromboembolism 34 / 8901 (0,4%) 60 / 8901 (0,7%) 0,57 [0,37;0,86]   12562
    Fatal stroke 3 / 8901 (0,0%) 6 / 8901 (0,1%) 0,50 [0,13;2,00]  
    Haemmorhagic stroke 6 / 8901 (0,1%) 9 / 8901 (0,1%) 0,67 [0,24;1,87]  
    new-onset diabetes 270 / 8901 (3,0%) 216 / 8901 (2,4%) 1,25 [1,05;1,49]   12095
    stroke (fatal and non fatal) 33 / 8901 (0,4%) 64 / 8901 (0,7%) 0,52 [0,34;0,78] Any stroke 
    Non fatal MI 22 / 8901 (0,2%) 62 / 8901 (0,7%) 0,35 [0,22;0,58] Nonfatal myocardial infarction 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:
  • 12095: Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, TognonStatins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials.Lancet 2010 Feb 27;375:735-742
  • 12562: Squizzato A, Galli M, Romualdi E, Dentali F, Kamphuisen PW, Guasti L, Venco A, Ageno WStatins, fibrates, and venous thromboembolism: a meta-analysis.Eur Heart J 2010 May;31:1248-56

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of median 1.9 year)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 3,48‰ 7,64‰ -0,42%
    All cause death 2,22% 2,77% -0,55%
    cardiovascular events 9,32‰ 1,76% -0,83%
    Venous thromboembolism 3,82‰ 6,74‰ -0,29%
    Fatal stroke 0,34‰ 0,67‰ -0,03%
    Haemmorhagic stroke 0,67‰ 1,01‰ -0,03%
    new-onset diabetes 3,03% 2,43% 0,61%
    stroke (fatal and non fatal) 3,71‰ 7,19‰ -0,35%
    Non fatal MI 2,47‰ 6,97‰ -0,45%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for primary prevention

    cholesterol lowering intervention in cardiovascular prevention for high risk patients with or without LDL cholesterol elevation

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations



    Reference(s)

    TrialResults-center ID TRC6751
    Trials register # NCT00239681
    Study web site link ,
    • Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Macfadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein.. N Engl J Med 2008 Nov 9;:
      Pubmed | Hubmed | Fulltext

    (c) 2004-2016 TrialResults-center - All Rights Reserved

    Tweet this  |  Facebook  |  notify a friend

    100Heart and vessels