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cholesterol lowering intervention in cardiovascular prevention for diabetic patients , clinical trials results

aggressive cholesterol-lowering versus moderate cholesterol-lowering
Post CABG (diabetic sub group), 1999
aggressive cholesterol-lowering
versus
moderate cholesterol-lowering
patients 1-11 years after CABGdouble blind
aggressive treatment versus standard teatment
SANDS, 2008
NCT00047424
aggressive targets of LDL-C of 70 mg/dL or lower and SBP of 115 mm Hg or lower
versus
standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower
adults with type 2 diabetes open
Follow-up duration: 3 years
US
atorvastatin versus placebo
ASCOT (diabetics sub group), 2003
10 mg atorvastatin
versus
placebo
hypertensive patients with no history of coronary heart disease (CHD) but at least three cardiovascular risk factors
Deutsche Diabetes Dialyse Studie (4D), 2005
atorvastatin 20mg daily
versus
matching placebo
patients with type 2 diabetes mellitus on maintenance hemodialysisdouble blind
Follow-up duration: 4 y (median)
ASPEN, 2006
atorvastatin 10mg daily
versus
placebo
patients s with type 2 diabetes and LDL cholesterol levels below contemporary guideline targetsdouble blind
Follow-up duration: 4y
ASPEN, 2006
atorvastatin 10mg
versus
placebo
subjects with type 2 diabetes and LDL cholesterol levels below contemporaryguideline targetsdouble blind
Follow-up duration: 4 year
14 countries
CARDS, 2004
NCT00327418
atorvastatin 10mg/d
versus
placebo
patients with type 2 diabetes without high concentrations of LDL-cholesterol and at least one of the following: retinopathy, albuminuria, current smoking, or hypertension.double blind
Follow-up duration: 3.9 years
UK, Irelande
atorvastatin high dose versus atorvastatin
TNT (diabetic sub group), 2006
atorvastatin 80 mg daily
versus
atorvastatin 10 mg daily
patients with stable coronary heart disease double blind
Follow-up duration: 4.9 y
bezafibrate versus placebo
SENDCAP, 1998
bezafibrate 400 mg daily
versus
placebo
type 2 diabetic subjects without a history of clinical cardiovascular double blind
Follow-up duration: 3.0 years
UK
clofibrate versus placebo
Hanefeld, 1991
clofibric acid 1.6 g/day
versus
placebo
newly diagnosed middle-aged (30- to 55-yr-old) patients with non-insulin-dependent diabetes mellitus double-blind
Follow-up duration: 5 years
Germany
Harrold, 1969
clofibrate
versus
placebo
diabetic retinopathy double-blind
Follow-up duration: 1 years
etofibrate versus placebo
Emmerich, 2009
etofibrate 1g/j
versus
placebo
patients with type 2 diabetes mellitus and concomitant diabetic retinopathydouble-blind
Follow-up duration: 12 months
Germany
fenofibrate versus placebo
FIELD, 2005
ISRCTN64783481
fenofibrate 200 mg daily
versus
placebo
aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry
Follow-up duration: 5y
DAIS, 2001
fenofibrate 200 mg/day
versus
placebo
men and women with type 2 diabetes and coronary atherosclerosis double-blind
Follow-up duration: 3.3 years
Canada, Finland, France, Sweden
fenofibrate versus placebo (on top simvastatine)
ACCORD lipid, 2010
NCT00000620
fenofibrate on top simvastatin
versus
placebo (on top simvastatine)
high-risk patients with type 2 diabetes double-blind
Follow-up duration: 4.7y
United States and Canada
fluvastatin versus placebo
LIPS (diabetic sub group), 2002
fluvastatin
versus
placebo
patients (aged 18-80 years) with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dLdouble blind
Follow-up duration: 3.9y
ALERT (diabetic sub group), 2003
fluvastatin
versus
placebo
renal transplant recipients with total cholesterol 4·0–9·0 mmol/Ldouble blind
gemfibrozil versus placebo
HHS (diabetic sub group), 1987
gemfibrozil 600mg twice daily
versus
placebo
asymptomatic middle-aged men (40 to 55 years of age) with primary dyslipidemia (non-HDL cholesterol greater than or equal to 200 mg per deciliter double blind
VA-HIT (diabetic sub group), 1999
gemfibrozil 1200 mg per day
versus
placebo
men with coronary heart disease, an HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less.double blind
Follow-up duration: 5.1 y
lovastatin versus placebo
AFCAPS/TexCAPS (diabetic sub group), 1998
lovastatin
versus
placebo
men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL-C) levelsdouble blind
pravastatin versus placebo
PROSPER diabetic (sub group), 2002
pravastatin 40mg daily
versus
placebo
mena and women aged 70–82 years with a history of, or risk factors for, vascular diseasedouble blind
Follow-up duration: 3.2y mean
LIPID (diabetic sub group), 1998
pravastatin 40 mg daily
versus
placebo
patients with a history of myocardial infarction or hospitalization for unstable angina and initial plasma total cholesterol levels of 155 to 271 mg per deciliterdouble blind
Follow-up duration: mean 6.1y
Australia, New Zealand
CARE (diabetic sub group), 1998
pravastatin
versus
placebo
men and postmenopausal women between 21 to 75 years of age, with MI between 3 and 20 months before randomization and plasma total cholesterol values <240mg/dL, LDL-C levels between 115 and 174mg/dL, and triglycerides <350mg/dL
WOSCOPS (diabetic sub group), 1996
pravastatin 40 mg daily
versus
placebo
men aged 45-64 years with no history of myocardial infarction and plasma total cholesterol concentrations of 6.5-8.0 mmol/L at initial screeningdouble blind
Follow-up duration: mean 4.9y
pravastatin versus usual care
GISSI P (diabetic sub group), 2000
pravastatin 20 mg daily
versus
usual care
recent acute myocardial infarction patients (< or = 6 months) with total blood cholesterol > or = 200 mg/dl open
Follow-up duration: median 24.3 months
ALLHAT-LLT (diabetic sub group), 2002
pravastatin
versus
usual care
Ambulatory persons aged 55 years or older, with lowdensity lipoprotein cholesterol (LDL-C) of 120 to 189 mg/dL (100 to 129 mg/dL if known CHD) and triglycerides lower than 350 mg/dLopen
pravastatin high dose versus pravastatin
PROVE IT TIMI 22 (diabetic sub group), 2006
pravastatin 80mg daily
versus
pravastatin 40mg daily
patients hospitalized for an acute coronary syndrome within the preceding 10 daysdouble blind
Follow-up duration: 24 months mean
simvastatin versus placebo
HPS (diabetic sub group), 2002
simvastatin 40mg daily
versus
placebo
Men and women diabetes aged about 40–80 years with non-fasting blood total cholesterol concentrations of at least 3·5 mmol/L (135 mg/dL)double blind
4S (diabetic sub group), 1999
simvastatin
versus
placebo
diabetic men and women aged 35 to 70 years with previous MI or active, stable angina pectoris and with serum total cholesterol level between 5.5 to 8.0 mmol/L and serum triglyceride level <=2.5 mmol/Ldouble blind
Follow-up duration: 5.4y
Denmark, Finland, Iceland, Norway, and Sweden
HPS (diabetic primary prevention sub group), 2003
simvastatin 40 mg/d
versus
placebo
adults (aged 40-80 years) with diabetes (primary prevention subgroup) double blind
Follow-up duration: 5 years
UK

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