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Table summary of clinical trials for pravastatin back     pdf    short list

Clinical trials of pravastatin (Pravastatin, Eptastatin, Liplat, Pravastatin Sodium, Pravastatin Sodium Salt, Pravastatin tert-Octylamine Salt, Pravastatin tert Octylamine Salt, RMS-431, RMS 431, RMS431, SQ-31000, SQ 31000, SQ31000, Vasten, Apo-Pravastatin, Apo Pravastatin, Bristacol, Nu-Pravastatin, Nu Pravastatin, CS-514, CS 514, CS514, Lin-Pravastatin, Lin Pravastatin, Lipemol, Prareduct, Mevalotin, Pravachol, Elisor, Selektine, Pravacol, Pravasin, Lipostat, , pravastatin dihydrodiol, ) are available for the clinical conditions:


Cardiovascular prevention

These trials are included in meta-analysis concerning: cholesterol lowering intervention in primary prevention, cholesterol lowering intervention in all chronical situations, cholesterol lowering intervention in elderly, cholesterol lowering intervention in diabetic patients, cholesterol lowering intervention in women, cholesterol lowering intervention in high risk patients with or without LDL cholesterol elevation, cholesterol lowering intervention in patients with prior MI or with CHD, cholesterol lowering intervention in patient with related disease, cholesterol lowering intervention in patients with other atherosclerotic localisation, cholesterol lowering intervention in patients with LDL elevation and without CHD,

pravastatin vs control
MEGA ,2006
NCT00211705 		pravastatin 10 mg daily (20 mg per day if the total cholesterolconcentration did not decrease to 5·69 mmol/L or less)
versus
control 		patients with hypercholesterolaemia (total cholesterol 5·69–6·98 mmol/L) and no history of coronary heart disease or stroke  Follow-up: 5.3 y
open, blind assessment
Japan 
FAST Fukuoka pravastatin ,2002 pravastatin 10 mg/day
versus
control group (diet alone) 		asymptomatic hypercholesterolemic patients   Follow-up: 2 years
open
Japan 
pravastatin vs placebo
WOSCOPS ,1995 pravastatine 40 mg daily
versus
placebo 		men aged 45-64 yr with no history of myocardial infarction and with raised plasma cholesterol levels (LDL cholesterol of at least 155 mg/dL, total cholesterol of at least 252 mg/dL)   Follow-up: 4.9 years
double blind
Scotland 
PROSPER (sub group) ,2002 pravastatin 40mg daily
versus
placebo 		mena and women aged 70–82 years with a history of, or risk factors for, vascular disease  Follow-up: 3.2y mean
double blind
 
LIPID (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 deciliter  Follow-up: mean 6.1y
double blind
Australia, New Zealand 
CARE (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  Follow-up:

 
WOSCOPS (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 screening  Follow-up: mean 4.9y
double blind
 
PROSPER ,2002 pravastatin 40mg daily
versus
placebo 		men and women aged 70-82 years with a history of, or risk factors for, vascular disease  Follow-up: 3.2 years
double blind
Ecosse, Irelande, Pays bas 
CARE (subgroup) ,1998 Pravastatin 40mg
versus
 MI 3–20 months, subgroup of age 65-75 y  Follow-up: 5.0y
double blind
 
LIPID (sub group) ,2001 Pravastatin 40mg
versus
 MI or unstable angina, subgroup of age 65-75 y  Follow-up: 6.1y
double blind
 
PLAC I (sub group) ,1995 Pravastatin 40mg
versus
 Angiographic CAD or recent MI, subgroup of age 65-75 y  Follow-up: 2.3y
double blind
 
REGRESS (subgroup) ,1995 Pravastatin 40mg
versus
 Angiographic CAD, subgroup of age 65-70 y  Follow-up: 2.0y
double blind
 
REGRESS ,1995 pravastatin 40 mg daily
versus
placebo 		symptomatic men with normal to moderately elevated serum cholesterol levels  Follow-up: 2 years
double blind
Netherlands 
PMSG ,1993 pravastatin 20 mg once daily
versus
placebo 		patients with hypercholesterolemia(serum total cholesterol concentrations of 5.2 to 7.8 mmol/liter) and > or = 2 additional risk factors for atherosclerotic coronary artery disease  Follow-up: 26 weeks
double blind
 
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/L  Follow-up: 6.1 years
double blind
Australie et Nouvelle Zélande 
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 deciliter  Follow-up: 5 years
double blind
USA, Canada 
CAIUS ,1996 pravastatin 40mg/d
versus
placebo 		asymptomatic patients with hypercholesterolemia and at least one 1.3 < IMT < 3.5 mm in the carotid arteries  Follow-up: 3 years
double blind
Italy 
PREVEND IT ,2004 pravastatin 40 mg daily
versus
placebo 		subjects with microalbuminuria  Follow-up: 46 months
double blind
the Netherlands 
Blann ,2001 Pravastatine : 40 mg / jour / per os pendant 4 mois
versus
placebo 		Claudication intermittente, TIA, et/ ou angine de poitrine :56.2%   Follow-up: 4 mois
Double aveugle
 
PLAC I ,1995 pravastatin 40mg daily
versus
placebo 		men and women with coronary artery disease and mild to moderate elevations in cholesterol levels  Follow-up: 3 y
double blind
United States 
PLAC II ,1995 pravastatin 20-40mg daily
versus
placebo 		coronary patients (men and women )  Follow-up: 3 y
double blind
United States 
PACT ,2004 pravastatin initiated within 24 hours of onset of synmptoms and for 4 weeks
versus
placebo 		patients with unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction <24 hours  Follow-up: 30 days
double blind
 
KAPS ,1995 pravastatin 40mg/d
versus
placebo 		Hypercholesterolemics men with serum LDL-C > or = 4.0 mmol/L and total cholesterol < 7.5 mmol/L  Follow-up: 3 years
double blind
Finland 
PHYLLIS ,2004 pravastatin (40 mg per day)
versus
placebo 		hypertensive, hypercholesterolemic patients with asymptomatic carotid atherosclerosis   Follow-up: 2.6 y
double-blind
Italy 
PROSPER (primary prevention subgroup) ,2002 pravastatin 40mg/d
versus
placebo 		men and women aged 70-82 years with a history of, or risk factors for, vascular disease; primary prevention subgroup   Follow-up: 3.2 years
double blind
Ecosse, Irelande, Pays bas 
ALLHAT (women subgroup) ,2002 Pravastatin 40 mg daily
versus
control 		Ambulatory persons, aged 55 years or older, with low-density lipoprotein cholesterol (LDL-C) of 120 to 189 mg/dL (100 to 129 mg/dL if known CHD) and triglycerides lower than 350 mg/dL- subgroup of women  Follow-up: 4.8 y
open
US 
MEGA (women subgroup) ,2006 Pravastatin 10–20 mg daily
versus
control 		patients with hypercholesterolaemia (total cholesterol 5.69-6.98 mmol/L) and no history of coronary heart disease or stroke- subgroup of women  Follow-up: 5.3 y
open
Japan 
pravastatin vs usual care
GISSI P (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   Follow-up: median 24.3 months
open
 
ALLHAT-LLT (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/dL  Follow-up:
open
 
ALLHAT ,2002
NCT00000542 		pravastatin 40mg/d
versus
usual care 		older, moderately hypercholesterolemic, hypertensive participants with at least 1 additional CHD risk factor  Follow-up: 4.8 years
open
USA, Puerto Rico, Canada 
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 recommendations  Follow-up: 23 months (mean)
open
Italy 
KLIS ,2000 pravastatin 10-20 mg/day
versus
conventional treatment 		Japanese men aged 45-74 years with serum total cholesterol of > or = 220 mg/dl (5.69 mmol/l), primary prevenion  Follow-up: 5 years
open
Japan 
pravastatin high dose vs 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 days  Follow-up: 24 months mean
double blind
 

Diabetes type 2

These trials are included in meta-analysis concerning: cholesterol lowering intervention in diabetic patients with or withour hypercholesterolemia,

pravastatin vs placebo
PROSPER (sub group) ,2002 pravastatin 40mg daily
versus
placebo 		mena and women aged 70–82 years with a history of, or risk factors for, vascular disease  Follow-up: 3.2y mean
double blind
 
LIPID (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 deciliter  Follow-up: mean 6.1y
double blind
Australia, New Zealand 
CARE (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  Follow-up:

 
WOSCOPS (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 screening  Follow-up: mean 4.9y
double blind
 
pravastatin vs usual care
GISSI P (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   Follow-up: median 24.3 months
open
 
ALLHAT-LLT (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/dL  Follow-up:
open
 
pravastatin high dose vs 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 days  Follow-up: 24 months mean
double blind
 

Acute coronary syndrome

These trials are included in meta-analysis concerning: cholesterol lowering intervention in early initiation,

pravastatin vs placebo
LAMIL ,1997 Pravastatin, 10-20 mg (starting at D3)
versus
Placebo 		patients suffering an acute myocardial infarction   Follow-up: 1 and 3 months
double blind
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   Follow-up: 1.5 months
double blind
Canada 
PAIS ,2001 Pravastatin, 40 mg (initiated within 48 hours of hospital admission)
versus
Placebo 		patients with acute coronary syndromes  Follow-up: 1 and 3 months
double blind
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 symptoms  Follow-up: 1 months
double blind
Australia 
pravastatin vs usual care
L-CAD ,2000 Pravastatin, 20-40 mg (strating on average at D6)
versus
Usual care 		patients with acute coronary syndrome   Follow-up: 1, 4, and 6 months
open
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 infarction  Follow-up: 1 and 6 months
open
Turkey 

Atrial fibrillation

These trials are included in meta-analysis concerning: prevention in patient with history of atrial fibrillation,

pravastatin vs control
Tveit ,2004 pravastatin 40 mg
versus
standard therapy 		AF >48 h and scheduled EC  Follow-up: 6 weeks

 

Percutaneous coronary intervention

These trials are included in meta-analysis concerning: statin in all type of patients,

pravastatin vs placebo
PREDICT ,1997 Pravastatin 40 mg/d 1 d after PCI
versus
placebo 		patient undergoing PCI  Follow-up: 6 mo
double blind
 

Post myocardial infarction

These trials are included in meta-analysis concerning: cholesterol lowering intervention in all type of patients,

pravastatin vs placebo
PACT ,2004 pravastatin initiated within 24 hours of onset of synmptoms and for 4 weeks
versus
placebo 		patients with unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction <24 hours  Follow-up: 30 days
double blind
 
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/L  Follow-up: 6.1 years
double blind
Australie et Nouvelle Zélande 
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 deciliter  Follow-up: 5 years
double blind
USA, Canada 

Peripheral vascular diseases

These trials are included in meta-analysis concerning: cholesterol lowering intervention in all type of patients,

pravastatin vs placebo
Blann ,2001 Pravastatine : 40 mg / jour / per os pendant 4 mois
versus
placebo 		Claudication intermittente, TIA, et/ ou angine de poitrine :56.2%   Follow-up: 4 mois
Double aveugle
 



Entry terms: Eptastatin, Pravastatin, Eptastatin, Vasten, Aventis Brand of Pravastatin Sodium, CS-514, CS 514, CS514, Lin-Pravastatin, Lin Pravastatin, Linson Pharma Brand of Pravastatin Sodium, Lipemol, Squibb Brand of Pravastatin Sodium, Liplat, Esteve Brand of Pravastatin Sodium, Nu-Pravastatin, Nu Pravastatin, Nu-Pharma Brand of Pravastatin Sodium, Prareduct, Sankyo Brand of Pravastatin Sodium, Mevalotin, Pravachol, Elisor, Selektine, Pravacol, Pravasin, Bristol-Myers Squibb Brand of Pravastatin Sodium, Lipostat, Pravastatin Monosodium Salt, (6 beta)-Isomer, Pravastatin Sodium, Pravastatin Sodium Salt, Sodium Salt, Pravastatin, Pravastatin tert-Octylamine Salt, Pravastatin tert Octylamine Salt, Pravastatin, (6 beta)-Isomer, RMS-431, RMS 431, RMS431, SQ-31000, SQ 31000, SQ31000, SQ-31,000, SQ 31,000, SQ31,000, Apo-Pravastatin, Apo Pravastatin, Apotex Brand of Pravastatin Sodium, Bristacol, Juste Brand of Pravastatin Sodium, R-416 (pravastatin metabolite), pravastatin dihydrodiol




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