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)

SHARP, 2010 - ezetimibe+simvastatin vs placebo

ARBITER-HALTS 6, 2010 - ezetimibe vs niacin

SEARCH, 2010 - simvastatin high dose vs simvastatin

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

ACCORD lipid (subgroup Eye study), 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)

Emmerich, 2009 - etofibrate vs placebo

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

JUPITER, 2008 - rosuvastatin vs placebo

SANDS, 2008 - aggressive treatment vs standard teatment

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

GISSI-HF rosuvastatine, 2008 - rosuvastatin vs placebo

SAGE, 2007 - atorvastatin high dose vs pravastatin

Krum, 2007 - rosuvastatin vs placebo

CORONA, 2007 - rosuvastatin vs placebo

METEOR, 2007 - rosuvastatin vs placebo

TNT (sub group), 2006 - atorvastatin high dose vs atorvastatin

MEGA, 2006 - pravastatin vs control

PROVE IT TIMI 22 (diabetic sub group), 2006 - pravastatin high dose vs pravastatin

SPARCL, 2006 - atorvastatin vs placebo

ASPEN, 2006 - atorvastatin vs placebo

ASPEN, 2006 - atorvastatin vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All diabetes type 2 clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of aggressive treatment
  •  
     SANDS study, 2008 TRC8901 
    [NCT00047424] download pdf: aggressive treatment | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment aggressive targets of LDL-C of 70 mg/dL or lower and SBP of 115 mm Hg or lower
    for achieving lipid goals, if lifestyle modification was unsuccessful, use of a statin drug was initiated. If the LDL-C goal was not reached with statin use, combination therapy with ezetimibe was initiated. In addition, the non–HDL-C goals were addressed using fish oil, fenofibrate, or niacin. For achieving BP goals, step 1 drugs were angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB), in case of intolerance to ACE inhibitors. Step 2 was use of hydrochlorothiazide. Steps 3 to 5 added calcium channel blockers, -blockers, and then -blockers and other vasodilators.
    Control treatment standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower

    Patients

    Patients adults with type 2 diabetes
    Inclusion criteria men and women with type 2 diabetes; aged 40 years or older; documented type 2 diabetes, plus LDL-C of at least 100 mg/dL and SBP greater than 130 mm Hg within the previous 12 months
    Exclusion criteria New York Heart Association class III or IV heart failure, SBP greater than 180mmHg, liver transaminase levels more than twice the upper limit of normal, or diagnosis of primary hyperlipidemia or hypercholesterolemia due to hyperthyroidism or nephrotic syndrome
    Baseline characteristics
    Age (mean), yrs 56 y 
    Women (%) 66% 
    Total cholesterol (mmol/l) 184 mg/dL 
    LDL (mmol/l) 104 mg/dL 
    HDL (mmol/l) 46 mg/dL 
    Triglycerides (mg/dl) 163 mg/dL 
    Diabetes(%) 100% 
    BMI (kg/m2) 33 

    Method and design

    Randomized effectives 252 / 247 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 3 years
    Number of centre 4
    Geographic area US
    Hypothesis Superiority
    Primary endpoint common carotid artery intimal medial thickness (IMT)


    Results

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

    cardiovascular events

    11 / 252
    8 / 247
    classic 1,35 [0,55;3,29]

    Adverse events

    74 / 252
    55 / 247
    1,32 [0,98;1,78]

    non cardiovascular death

    2 / 252
    4 / 247
    classic 0,49 [0,09;2,65]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    cardiovascular events 11 / 252 (4,4%) 8 / 247 (3,2%) 1,35 [0,55;3,29]   0
    Adverse events 74 / 252 (29,4%) 55 / 247 (22,3%) 1,32 [0,98;1,78] serious adverse events  0
    non cardiovascular death 2 / 252 (0,8%) 4 / 247 (1,6%) 0,49 [0,09;2,65]   0
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 3 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    cardiovascular events 4,37% 3,24% 1,1%
    Adverse events 29,37% 22,27% 7,1%
    non cardiovascular death 7,94‰ 1,62% -0,83%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    cholesterol lowering intervention in cardiovascular prevention for diabetic patients

    cholesterol lowering intervention in diabetes type 2 for diabetic patients with or withour hypercholesterolemia



    Reference(s)

    TrialResults-center ID TRC8901
    Trials register # NCT00047424
    • Fleg JL, Mete M, Howard BV, Umans JG, Roman MJ, Ratner RE, Silverman A, Galloway JM, Henderson JA, Weir MR, Wilson C, Stylianou M, Howard WJ. Effect of Statins Alone Versus Statins Plus Ezetimibe on Carotid Atherosclerosis in Type 2 Diabetes The SANDS (Stop Atherosclerosis in Native Diabetics Study) Trial.. J Am Coll Cardiol 2008 Dec 16;52:2198-205 - 10.1016/j.jacc.2008.10.031
      Pubmed | Hubmed | Fulltext
    • Howard BV, Roman MJ, Devereux RB, Fleg JL, Galloway JM, Henderson JA, Howard WJ, Lee ET, Mete M, Poolaw B, Ratner RE, Russell M, Silverman A, Stylianou M, Umans JG, Wang W, Weir MR, Weissman NJ, Wilson C, Yeh F, Zhu J. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial.. JAMA 2008;299:1678-89
      Pubmed | Hubmed | Fulltext

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

    Tweet this  |  Facebook  |  notify a friend

    100Heart and vessels