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cholesterol lowering intervention in cardiovascular prevention for patients with prior MI or with CHD, clinical trials results

any statin versus no statin
Sakamoto, 2006
any available statin
versus
no statin
Japanese patients with AMI within 96 hours of AMI onset open
Follow-up duration: up to 24 months
Japan
atorvastatin versus placebo
MIRACL, 2001
Atorvastatin, 80 mg (early initiation)
versus
Placebo
unstable angina or non–Q-wave acute MIDouble blind
Follow-up duration: 1 and 4 months
Europe, North America, South Africa, and Australasia
macin, 2005
atorvastatin 40 mg daily for 30 days
versus
placebo
patients admitted within 48 hours of onset of ACS with CRP levels > or =1.4 mg/dLdouble-blind
Follow-up duration: 30 days
atorvastatin versus pravastatin
PROVE IT - TIMI 22, 2004
80 mg of atorvastatin daily (intensive therapy).
versus
40 mg of pravastatin daily (standard therapy)
patients who had been hospitalized for an acute coronary syndrome within the preceding 10 daysdouble blind
Follow-up duration: 24 mo (18-36 mo)
UK, US, AUstralia, Italy, France, Germany, Spain, Canada
atorvastatin versus usual care
Colivicchi, 2002
Atorvastatin, 80 mg daily early initiation
versus
Usual care
unstable angina pectoris or non-Q-wave myocardial infarctionopen
Follow-up duration: 1, 3, and 6 months
Italy
ESTABLISH, 2004
Atorvastatin, 20 mg early initiation
versus
Usual care
patients with ACS undergoing emergency coronary angiography and percutaneous coronary interventionopen
Follow-up duration: 1, 4, and 6 months
Japan
GREACE, 2002
atorvastatin 10-80 mg/d
versus
usual care
patients with established coronary heart diseaseopen
Follow-up duration: 3 years mean
atorvastatin high dose versus atorvastatin
TNT, 2005
NCT00327691
80 mg of atorvastatin daily
versus
10 mg of atorvastatin daily
Chronic coronary artery disease LDL cholesterol < 3.4 mmol/Ldouble blind
Follow-up duration: 4.9 years
14 countries
atorvastatin high dose versus lovastatin
Vascular basis, 2005
atorvastatin (80 mg) with or without vitamin C and E
versus
low dose lovastatin (5 mg)
Chronic coronary artery diseasedouble blind
Follow-up duration: 1 year
atorvastatin high dose versus pravastatin
PROVE-IT, 2004
atorvastatin 80 mg daily
versus
Pravastatin 40 mg
acute myocardial infarction (with or without electrocardiographic evidence of ST-segment elevation) or highrisk unstable angina) in the preceding 10 daysdouble blind
Follow-up duration: 2 years
8 countries
REVERSAL, 2004
atorvastatin 80 mg daily
versus
Pravastatin(40 mg)
Chronic coronary artery diseasedouble blind
Follow-up duration: 1.5 years
SAGE, 2007
atorvastatin 80 mg daily
versus
pravastatin(40 mg)
Chronic coronary artery diseasedouble blind
Follow-up duration: 1 years
atorvastatin high dose versus simvastatin
IDEAL, 2005
NCT00159835
atorvastatin 80mg daily
versus
simvastatine 20mg/j
Men and women aged 80 years or younger with a history of a definite myocardial infarction and who qualified for statin therapy according to national guidelinesopen
Follow-up duration: 4.8 years
Denmark, Finland, Iceland, Netherlands, Norway, Sweden
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
cholestyramine versus control
STARS (cholestyramine), 1992
cholestyramine
versus
diet
patients with angina or past myocardial infarction
Follow-up duration: 3 years
colestipol versus placebo
Gross, 1973
colestipol
versus
placebo

Follow-up duration: 1.0 years
colestipol-niacin versus placebo
CLAS, 1987
colestipol + niacin
versus
placebo
nonsmoking men aged 40 to 59 years with previous coronary bypass surgerydouble blind
Follow-up duration: 2 years
darapladib versus placebo
SOLID-TIMI 52,
NCT01000727

versus
diet versus usual diet
Kallio, 1979
diet (multifactorial intervention programme)
versus
usual diet
patients below 65 years who had an acute myocardial infarction open
Follow-up duration: 3.0 years
Los Angeles VA (Dayton), 1969
diet
versus
usual diet
men in domicilary care, age>55, with or without CHDdouble blind
Follow-up duration: 8.0 y
USA
Ornish, 1990
low-fat vegetarian diet, stopping smoking, stress management training, and moderate exercise
versus
usual-care
Patients with angiographically documented coronary artery diseaseopen
Follow-up duration: 1.0 y
USA
Rose, 1965
Régime restreint en graisses + 80 g/j huile de maïs
versus
usual diet
men, <70 yearsopen
Follow-up duration: 1.2 years
Singh, 1992
strict diet
versus
usual diet
patients with suspected acute myocardial infarctionopen
Follow-up duration: 2.0 years
STARS (St Thomas, diet), 1992
dietary advice
versus
usual diet
patients with angina or past myocardial infarction open, blind assessment
Follow-up duration: 3.0 years
estrogen versus placebo
CDP estrogen 2.5, 1975
estrogen 2.5 mg daily
versus
placebo

Follow-up duration: 4.7 years
CDP estrogen 5, 1975
estrogen 5.0 mg daily
versus
placebo

Follow-up duration: 1.5 years
Marmorstein, 1962
estrogen
versus
placebo

Follow-up duration: 5.0 y
Stamler, 1963
estrogen
versus
placebo

Follow-up duration: 5.0 years
estrogen or thyroxine versus placebo
VA drugs (Estrogen or thyroxine), 1968
estrogen or thyroxine
versus
placebo

Follow-up duration: 3.2 years
ezetimibe versus placebo (on top statins)
IMPROVE-IT, 2014
NCT00202878
10 mg/day of ezetimibe and 40 mg/day of simvastatin
versus
simvastatin 40 mg/day
subjects with stabilized high-risk acute coronary syndrome double blind
Follow-up duration: 5.68 years
39 countries
fluvastatin versus placebo
LIPS (sub groups), 2002
Fluvastatin, 80 mg
versus
Placebo
patients with unstable angina and successful first percutaneous coronary interventiondouble blind
Follow-up duration: 1, 4, and 6 months
Europe, Canada, and Brazil
FLORIDA, 2002
Fluvastatin, 80 mg (early initiation)
versus
Placebo
patients with an AMI and total cholesterol of <6.5 mmol.ldouble blind
Follow-up duration: 1, 4, and 6 months
The Netherlands
FLARE, 1999
fluvastatin 40 mg twice daily
versus
placebo
successful coronary balloon angioplastydouble blind
Follow-up duration: 40 weeks
LCAS, 1997
fluvastatin 20 mg twice daily
versus
placebo
men and women aged 35 to 75 years with angiographic CHD and mean low-density lipoprotein (LDL) cholesterol of 115 to 190 mg/dl despite dietdouble-blind
Follow-up duration: 2.5 years
Riegger et al., 1999
fluvastatin 40 mg (o.a.d. or b.i.d.)
versus
placebo
hyperlipidaemic patients with symptomatic, clinically-diagnosed (exercise-ECG) coronary heart disease double blind
Follow-up duration: 1.0 years
gemfibrozil versus placebo
HHS (Frick)(secondary prev subgroup), 1993
gemfibrozil 600 mg twice daily
versus
placebo
individuals who exhibited symptoms and signs of possible coronary heart disease double blind
Follow-up duration: 5.0 years
Sweden
LOCAT, 1997
gemfibrozil 1200 mg/d
versus
placebo
post-coronary bypass men, who had an HDL cholesterol concentration < or = 1.1 mmol/L and LDL cholesterol < or = 4.5 mmol/Ldouble blind
Follow-up duration: 32 months
Germany
VA-HIT, 1999
NCT00283335
gemfibrozil 1.2g daily
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 lessdouble blind
Follow-up duration: 5.1 years
USA
lovastatin versus usual care
CLAPT, 1999
lovastatin begun at 20 mg daily and tritrated up to 80 mg daily
versus
usual care
patients underwenting PTCA open (blind assessement)
Follow-up duration: 2.0 years
Sahni, 1991
lovastatin 20-40mg/d
versus
conventional therapy alone
patients undergoing successful PTCA open
Follow-up duration: 2 years
low fat diet versus mediterranean-style diet
Tuttle, 2008
low-fat
versus
Mediterranean-style diets
First MI survivorsopen
Follow-up duration: 24 months
niacin versus control
VA drugs, 1968
niacin
versus
double blind
Follow-up duration: 3.2 years
niacin versus placebo
CDP niacin, 1975
niacin 3 mg/d
versus
placebo
Hommes, de 30 à 64 ans double blind
Follow-up duration: 6.2 years
partial ileum bypass surgery versus no surgery
POSCH, 1990
NCT00000490
partial ileum bypass surgery
versus
no surgery
survivors to a first myocardial infarctionopen
Follow-up duration: 9.7 years
pitavastatin versus atorvastatin
JAPAN ACS, 2009
NCT00242944
pitavastatin 4 mg daily
versus
atorvastatin 20mg daily
patients with acute coronary syndrome undergoing IVUS-guided percutaneous coronary intervention open
Follow-up duration: 8-12 months
Japan
pravastatin versus placebo
LAMIL, 1997
Pravastatin, 10-20 mg (starting at D3)
versus
Placebo
patients suffering an acute myocardial infarction double blind
Follow-up duration: 1 and 3 months
Belgium
RECIFE, 1999
Pravastatin, 40 mg
versus
Placebo
Patients with acute myocardial infarction or unstable angina and total cholesterol levels at admission >=5.2 mmol/L or LDL >=3.4 mmol/L double blind
Follow-up duration: 1.5 months
Canada
PAIS, 2001
Pravastatin, 40 mg (initiated within 48 hours of hospital admission)
versus
Placebo
patients with acute coronary syndromesdouble blind
Follow-up duration: 1 and 3 months
The Netherlands
PACT, 2004
Pravastatin, 20-40 mg within 24 hours of the onset of symptoms in
versus
Placebo
patients with unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction within 24 hours of the onset of symptomsdouble blind
Follow-up duration: 1 months
Australia
CARE, 1996
pravastatin 40 mg/d
versus
placebo
men and women with myocardial infarction who had plasma totalcholesterol levels below 240 mg per deciliter (mean,209) and low-density lipoprotein (LDL) cholesterollevels of 115 to 174 mg per deciliterdouble blind
Follow-up duration: 5 years
USA, Canada
LIPID, 1998
pravastatin 40 mg/d
versus
placebo
patients with previous myocardial infarction or unstable angina and a baseline plasma cholesterol concentration of 4.0-7.0 mmol/Ldouble blind
Follow-up duration: 6.1 years
Australie et Nouvelle Zélande
pravastatin versus usual care
L-CAD, 2000
Pravastatin, 20-40 mg (strating on average at D6)
versus
Usual care
patients with acute coronary syndrome open
Follow-up duration: 1, 4, and 6 months
Germany
PTT, 2002
Pravastatin, 40 mg
versus
Usual care
patients who underwent coronary balloon angioplasty of the infarct-related artery during the first month of acute myocardial infarctionopen
Follow-up duration: 1 and 6 months
Turkey
OACIS-LIPID, 2008
pravastatin 10 mg/daily
versus
no pravastatin
patients with AMI who had plasma total cholesterol levels of 200-250 mg/dl and triglyceride levels <300 mg/dlopen
Follow-up duration: 9 months
GISSI Prevenzione, 2000
low-dose pravastatin regimen 20 mg daily
versus
control
recent acute myocardial infarction patients (<= 6 months) with total blood cholesterol >= 200 mg/dl and < 250 mg/dl and after a period of 3–6 months showed plasma cholesterol levels >=200 mg/ dL despite adequate dietary recommendationsopen
Follow-up duration: 23 months (mean)
Italy
Probucol versus placebo
McCaughan, 1981
probucol
versus
placebo
hypercholesterolemic mendouble-blind
Follow-up duration: 1 year
Tardif, 1997
probucol 500 mg
versus
placebo
patients undergoing PTCAopen
Follow-up duration: 0.5 years
simvastatin versus placebo
4S, 1994
simvastatin 20 or 40 mg/d, target CT between 3 et 5.2 mmol/l
versus
placebo
patients with angina pectoris or previous myocardial infarction and serum cholesterol 5.5-8.0 mmol/L on a lipid-lowering diet double blind
Follow-up duration: 5.4 years
Scandinavia
A to Z, 2004
Simvastatin, 40-80 mg early initiation
versus
Placebo
patient with an acute coronary syndrome (ACS)Double aveugle
Follow-up duration: 4 months
41 countries
Ren, 2009
simvastatin (40 mg/d for 4 weeks)
versus
placebo
patients with unstable angina pectoris double-blind
CIS, 1997
simvastatin 40 mg
versus
placebo
men with documented coronary artery disease and hypercholesterolaemia double blind
Follow-up duration: 2.3 years
HPS, 2002
simvastatin 40 mg/d
versus
placebo
adults (aged 40-80 years) with coronary disease, other occlusive arterial disease, or diabetedouble blind
Follow-up duration: 5 years
UK
simvastatin high dose versus simvastatin
SEARCH, 2010
NCT00124072
simvastatin 80 mg daily
versus
simvastatin 20mg daily
MI survivors
Follow-up duration: 6.7 years (mean)
thyroxine versus placebo
CDP tyroxine, 1975
thyroxine
versus
placebo

Follow-up duration: 3.0 years
various drugs versus placebo
HARP, 1994
NCT00000461
Various drugs (pravastatin, nicotinic acid, cholestyramine, and gemfibrozil stepwise as needed to reach the specified goal (total cholesterol < or = 4.1 mmol/L, ratio of LDL/high-density-lipoprotein [HDL] cholesterol < or = 2.0)
versus
placebo
normocholesterolaemic patients with coronary heart disease open
Follow-up duration: 2.5 years
various drugs versus usual care
SCRIP, 1994
NCT00000508
multifactor risk reduction (Various drugs)
versus
usual care
patients with angiographically defined coronary atherosclerosis open
Follow-up duration: 4.0 years

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