Trial-Results center  
Clinical trial results database in 100 Feedback    Home


Related trials

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

SHARP, 2010 - ezetimibe+simvastatin vs placebo

SEARCH, 2010 - simvastatin high dose vs simvastatin

ARBITER-HALTS 6, 2010 - ezetimibe vs niacin

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

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

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

JUPITER (sub group), 2009 - rosuvastatin vs placebo

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

Emmerich, 2009 - etofibrate vs placebo

SANDS, 2008 - aggressive treatment vs standard teatment

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

JUPITER, 2008 - rosuvastatin vs placebo

GISSI-HF rosuvastatine, 2008 - rosuvastatin vs placebo

CORONA, 2007 - rosuvastatin vs placebo

Krum, 2007 - rosuvastatin vs placebo

SAGE, 2007 - atorvastatin high dose vs pravastatin

METEOR, 2007 - rosuvastatin vs placebo

MEGA, 2006 - pravastatin vs control

Patti et al., 2006 - preoperative atorvastatin vs placebo

ASPEN, 2006 - atorvastatin vs placebo

Chello et al., 2006 - preoperative atorvastatin vs placebo

SPARCL, 2006 - atorvastatin vs placebo

Hong, 2005 - simvastatin vs control

IDEAL, 2005 - atorvastatin high dose vs simvastatin



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of pravastatin
  •  

    PROSPER study, 2002

    download pdf: pravastatin | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment pravastatin 40mg daily
    Control treatment placebo
    Treatments description
    LDL change -34% 
    HDL change +5% 

    Patients

    Patients men and women aged 70-82 years with a history of, or risk factors for, vascular disease
    Inclusion criteria men and women aged 70–82 years; either pre-existing vascular disease (coronary, cerebral, or peripheral) or raised risk of such disease because of smoking, hypertension, or diabetes; total cholesterol between 4·0–9·0 mmol/L; triglyceride less than 6·0 mmol/L
    Exclusion criteria poor cognitive function (mini mental state examination score <24)
    Baseline characteristics
    Age (mean), yrs 75.35 
    Women (%) 51.7% 
    prior MI or CHD (%) 13.35 
    Total cholesterol (mmol/l) 5.7 mmol/L 
    LDL (mmol/l) 3.8 mmol/L 
    HDL (mmol/l) 1.3 mmol/L 
    Diabetes(%) 10.75 
    BMI (kg/m2) 26.8 
    Stroke history 11.15 

    Method and design

    Randomized effectives 2891 / 2913 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 3.2 years
    Lost to follow-up ND
    Number of centre multicenter
    Geographic area Ecosse, Irelande, Pays bas
    Hypothesis Superiority
    Primary endpoint death, MI , stroke


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Non-fatal myocardial infarction 222 / 2891 (7,7%) 254 / 2913 (8,7%) 0,88 [0,74;1,05]
    Non-fatal myocardial infarction 222 / 2891 (7,7%) 254 / 2913 (8,7%) 0,88 [0,74;1,05]
    CHD death or non-fatal MI (excluding silent and unrecognised events) 193 / 2891 (6,7%) 246 / 2913 (8,4%) 0,79 [0,66;0,95]
    Non-fatal stroke 116 / 2891 (4,0%) 119 / 2913 (4,1%) 0,98 [0,76;1,26]
    Transient ischaemic attack 77 / 2891 (2,7%) 102 / 2913 (3,5%) 0,76 [0,57;1,02]
    Percutaneous transluminal coronary angioplasty, CABG 39 / 2891 (1,3%) 48 / 2913 (1,6%) 0,82 [0,54;1,25]
    Peripheral arterial surgery/angioplasty 35 / 2891 (1,2%) 45 / 2913 (1,5%) 0,78 [0,51;1,22]
    All cardiovascular events 454 / 2891 (15,7%) 523 / 2913 (18,0%) 0,87 [0,78;0,98]
    Fatal or non-fatal stroke or transient ischaemic attack 204 / 2891 (7,1%) 212 / 2913 (7,3%) 0,97 [0,81;1,17]
    Heart failure hospitalisation 112 / 2891 (3,9%) 122 / 2913 (4,2%) 0,93 [0,72;1,19]
    Coronary heart disease deaths 94 / 2891 (3,3%) 122 / 2913 (4,2%) 0,78 [0,60;1,01]
    Stroke deaths 22 / 2891 (0,8%) 14 / 2913 (0,5%) 1,58 [0,81;3,09]
    Vascular deaths 135 / 2891 (4,7%) 157 / 2913 (5,4%) 0,87 [0,69;1,08]
    Non-vascular deaths 163 / 2891 (5,6%) 149 / 2913 (5,1%) 1,10 [0,89;1,37]
    Cancer deaths 115 / 2891 (4,0%) 91 / 2913 (3,1%) 1,27 [0,97;1,67]
    Trauma or suicide deaths 2 / 2891 (0,1%) 7 / 2913 (0,2%) 0,29 [0,06;1,38]
    All causes deaths 298 / 2891 (10,3%) 306 / 2913 (10,5%) 0,98 [0,84;1,14]
    CHD death or non-fatal MI, stroke 408 / 2891 (14,1%) 473 / 2913 (16,2%) 0,87 [0,77;0,98]
    CHD death or non-fatal MI 292 / 2891 (10,1%) 356 / 2913 (12,2%) 0,83 [0,71;0,96]
    Fatal or non-fatal stroke 135 / 2891 (4,7%) 131 / 2913 (4,5%) 1,04 [0,82;1,31]

    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

    292 / 2891
    356 / 2913
    0,83 [0,71;0,96]

    All cause death

    298 / 2891
    306 / 2913
    0,98 [0,84;1,14]

    Cardiovascular death

    135 / 2891
    157 / 2913
    0,87 [0,69;1,08]

    cardiovascular events

    408 / 2891
    473 / 2913
    0,87 [0,77;0,98]

    Fatal stroke

    22 / 2891
    14 / 2913
    classic 1,58 [0,81;3,09]

    new-onset diabetes

    165 / 2510
    127 / 2513
    1,30 [1,04;1,63]

    Coronary death

    94 / 2891
    122 / 2913
    0,78 [0,60;1,01]

    stroke (fatal and non fatal)

    135 / 2891
    131 / 2913
    1,04 [0,82;1,31]

    MACE

    454 / 2891
    523 / 2913
    0,87 [0,78;0,98]

    Non fatal MI

    222 / 2891
    254 / 2913
    0,88 [0,74;1,05]

    Rhabdomyolysis

    0 / 2891
    0 / 2913
    classic 1,01 [0,00;257,51]

    Death from cancer

    115 / 2891
    91 / 2913
    1,27 [0,97;1,67]

    Myopathy

    36 / 2891
    32 / 2913
    1,13 [0,71;1,82]

    Coronary death and non fatal MI

    292 / 2891
    356 / 2913
    0,83 [0,71;0,96]

    cardiac death

    94 / 2891
    122 / 2913
    0,78 [0,60;1,01]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 292 / 2891 (10,1%) 356 / 2913 (12,2%) 0,83 [0,71;0,96]   1757
    All cause death 298 / 2891 (10,3%) 306 / 2913 (10,5%) 0,98 [0,84;1,14]  
    Cardiovascular death 135 / 2891 (4,7%) 157 / 2913 (5,4%) 0,87 [0,69;1,08]  
    cardiovascular events 408 / 2891 (14,1%) 473 / 2913 (16,2%) 0,87 [0,77;0,98]   1757
    Fatal stroke 22 / 2891 (0,8%) 14 / 2913 (0,5%) 1,58 [0,81;3,09]  
    new-onset diabetes 165 / 2510 (6,6%) 127 / 2513 (5,1%) 1,30 [1,04;1,63] sub group  12095
    Coronary death 94 / 2891 (3,3%) 122 / 2913 (4,2%) 0,78 [0,60;1,01]  
    stroke (fatal and non fatal) 135 / 2891 (4,7%) 131 / 2913 (4,5%) 1,04 [0,82;1,31]  
    MACE 454 / 2891 (15,7%) 523 / 2913 (18,0%) 0,87 [0,78;0,98]   1757
    Non fatal MI 222 / 2891 (7,7%) 254 / 2913 (8,7%) 0,88 [0,74;1,05]  
    Rhabdomyolysis 0 / 2891 (0,0%) 0 / 2913 (0,0%) 1,01 [0,02;50,77]  
    Death from cancer 115 / 2891 (4,0%) 91 / 2913 (3,1%) 1,27 [0,97;1,67]  
    Myopathy 36 / 2891 (1,2%) 32 / 2913 (1,1%) 1,13 [0,71;1,82]  
    Coronary death and non fatal MI 292 / 2891 (10,1%) 356 / 2913 (12,2%) 0,83 [0,71;0,96]  
    cardiac death 94 / 2891 (3,3%) 122 / 2913 (4,2%) 0,78 [0,60;1,01]   1757
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 1757: Shepherd J, Blauw GJ, Murphy MB, Bollen EL, Buckley BM, Cobbe SM, Ford I, Gaw A, Hyland M, Jukema JW, Kamper AM, Macfarlane PW, Meinders AE, Norrie J, Packard CJ, Perry IJ, Stott DJ, Sweeney BJ, Twomey C, Westendorp RG,Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial.Lancet 2002; 360:1623-30
  • 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
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 10,10% 12,22% -21,2‰
    All cause death 10,31% 10,50% -2,0‰
    Cardiovascular death 4,67% 5,39% -7,2‰
    cardiovascular events 14,11% 16,24% -21,2‰
    Fatal stroke 7,61‰ 4,81‰ 2,8‰
    new-onset diabetes 6,57% 5,05% 1,5%
    Coronary death 3,25% 4,19% -9,4‰
    stroke (fatal and non fatal) 4,67% 4,50% 1,7‰
    MACE 15,70% 17,95% -22,5‰
    Non fatal MI 7,68% 8,72% -10,4‰
    Death from cancer 3,98% 3,12% 8,5‰
    Myopathy 1,25% 1,10% 1,5‰
    Coronary death and non fatal MI 10,10% 12,22% -21,2‰
    cardiac death 3,25% 4,19% -9,4‰

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    cholesterol lowering intervention in cardiovascular prevention for elderly

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



    Reference(s)

    Trials register # NA
    • Shepherd J, Blauw GJ, Murphy MB, Bollen EL, Buckley BM, Cobbe SM, Ford I, Gaw A, Hyland M, Jukema JW, Kamper AM, Macfarlane PW, Meinders AE, Norrie J, Packard CJ, Perry IJ, Stott DJ, Sweeney BJ, Twomey C, Westendorp RG,. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial.. Lancet 2002; 360:1623-30
      Pubmed | Hubmed | Fulltext

    (c) 2004-2014 TrialResults-center - All Rights Reserved

    Tweet this  |  Facebook  |  notify a friend

    100100