| Trial | control | p<0.05 | harm | NS |
|---|
| PROSPER diabetic (sub group), 2002 | pravastatin vs placebo | | | Critère de jugement principal de l'étude 0.80 [0.59; 1.09] Cv events (CV death, MI, stroke) 0.80 [0.59; 1.09] |
| LIPID (diabetic sub group), 1998 | pravastatin vs placebo | | | Critère de jugement principal de l'étude 0.84 [0.64; 1.11] Infarctus non mortel et décès coronariens 0.84 [0.64; 1.11] Evénement coronarien majeur 0.84 [0.64; 1.11] |
| CARE (diabetic sub group), 1998 | pravastatin vs placebo | Critère de jugement principal de l'étude 0.78 [0.62; 0.99] Evénement coronarien majeur 0.78 [0.62; 0.99] | | Infarctus non mortel et décès coronariens 0.87 [0.62; 1.22] AVC 0.85 [0.48; 1.52] |
| WOSCOPS (diabetic sub group), 1996 | pravastatin vs placebo | | | |
| PROSPER, 2002 | pravastatin vs placebo | cardiovascular events 0.87 [0.77; 0.98] Demonstrated coronary events 0.83 [0.71; 0.96] CV events (including revascularization) 0.87 [0.78; 0.98] Infarctus non mortel et décès coronariens 0.83 [0.71; 0.96] | incident diabetes 1.32 [1.03; 1.69] | Pancreatitis 0.46 [0.16; 1.32] all cause deaths 0.98 [0.84; 1.14] coronary deaths 0.78 [0.60; 1.01] cardiovascular death 0.87 [0.69; 1.08] décès par cancer 1.27 [0.97; 1.67] fatal stroke 1.58 [0.81; 3.09] MI non fatal 0.88 [0.74; 1.05] Rhabdomyolyses NaN [NaN; NaN] stroke (fatal et non fatal) 1.04 [0.82; 1.31] cardiac death 0.78 [0.60; 1.01] Myopathies 1.13 [0.71; 1.82] |
| ALLHAT, 2002 | pravastatin vs usual care | | | all cause deaths 0.99 [0.89; 1.09] coronary deaths 0.99 [0.80; 1.23] coronary events 0.91 [0.79; 1.03] cardiovascular death 0.99 [0.84; 1.15] décès par cancer 1.10 [0.89; 1.38] fatal stroke 0.95 [0.65; 1.38] Cancers mortels et non mortels 1.03 [0.89; 1.18] stroke (fatal et non fatal) 0.91 [0.76; 1.09] cardiac death 0.99 [0.80; 1.23] cardiovascular events 0.91 [0.79; 1.03] Infarctus non mortel et décès coronariens 0.91 [0.79; 1.03] non cardiovascular death 1.00 [0.86; 1.17] incident diabetes 1.15 [0.94; 1.40] |
| PLAC I, 1995 | pravastatin vs placebo | CV events (including revascularization) 0.67 [0.50; 0.88] | | all cause deaths 0.65 [0.19; 2.28] coronary events 0.46 [0.20; 1.05] stroke (fatal et non fatal) 0.00 [0.00; NaN] cardiovascular events 0.88 [0.62; 1.26] Infarctus non mortel et décès coronariens 0.52 [0.25; 1.08] non cardiovascular death 0.33 [0.03; 3.12] |
| PLAC II, 1995 | pravastatin vs placebo | | | cardiovascular events 0.68 [0.35; 1.30] non cardiovascular death 0.34 [0.04; 3.17] |
| PACT, 2004 | pravastatin vs placebo | | | all cause deaths 0.64 [0.39; 1.07] coronary deaths 0.99 [0.46; 2.12] MI non fatal 1.07 [0.73; 1.57] |
| KAPS, 1995 | pravastatin vs placebo | | | all cause deaths 0.75 [0.17; 3.30] coronary deaths 0.00 [0.00; NaN] coronary events 0.37 [0.10; 1.39] CV events (including revascularization) 0.78 [0.36; 1.69] cardiovascular events 0.78 [0.36; 1.69] Infarctus non mortel et décès coronariens 0.62 [0.21; 1.87] non cardiovascular death 0.50 [0.05; 5.45] |
| LIPID, 1998 | pravastatin vs placebo | coronary deaths 0.77 [0.66; 0.89] Demonstrated all cause deaths 0.78 [0.70; 0.88] coronary events 0.78 [0.70; 0.86] cardiovascular death 0.76 [0.67; 0.87] Infarctus non mortel et décès coronariens 0.78 [0.70; 0.86] | | Pancreatitis 0.52 [0.26; 1.04] décès par cancer 0.91 [0.72; 1.15] Haemorrhagic strokes 2.00 [0.81; 4.94] fatal stroke 0.81 [0.46; 1.43] Rhabdomyolyses 0.00 [0.00; NaN] stroke (fatal et non fatal) 0.83 [0.68; 1.01] Myopathies 0.84 [0.60; 1.19] incident diabetes 0.91 [0.59; 1.41] |
| CARE, 1996 | pravastatin vs placebo | coronary events 0.77 [0.65; 0.91] Demonstrated MI non fatal 0.78 [0.63; 0.97] stroke (fatal et non fatal) 0.69 [0.49; 0.97] | | Pancreatitis 0.88 [0.44; 1.76] all cause deaths 0.92 [0.76; 1.11] coronary deaths 0.83 [0.63; 1.08] décès par cancer 1.09 [0.73; 1.62] Haemorrhagic strokes 0.33 [0.07; 1.65] fatal stroke 4.99 [0.58; 42.70] Rhabdomyolyses NaN [NaN; NaN] Myopathies 0.00 [0.00; NaN] non cardiovascular death 1.09 [0.80; 1.48] |
| WOSCOPS, 1995 | pravastatin vs placebo | coronary events 0.70 [0.58; 0.84] Demonstrated all cause deaths 0.78 [0.61; 1.00] cardiovascular death 0.68 [0.48; 0.98] MI non fatal 0.70 [0.57; 0.86] cardiovascular events 0.58 [0.48; 0.71] Infarctus non mortel et décès coronariens 0.70 [0.58; 0.84] | | Pancreatitis 0.40 [0.08; 2.05] coronary deaths 0.73 [0.48; 1.10] décès par cancer 0.90 [0.60; 1.34] fatal stroke 1.50 [0.42; 5.30] Rhabdomyolyses NaN [NaN; NaN] stroke (fatal et non fatal) 0.90 [0.61; 1.34] cardiac death 0.73 [0.48; 1.10] non cardiovascular death 0.82 [0.60; 1.12] incident diabetes 0.79 [0.57; 1.09] |
| LAMIL, 1997 | pravastatin vs placebo | | | fatal MI ∞ [NaN; ∞] death, MI and stroke - 4 month 0.92 [0.20; 4.23] |
| RECIFE, 1999 | pravastatin vs placebo | | | Death NaN [NaN; NaN] fatal MI NaN [NaN; NaN] Revascularisation NaN [NaN; NaN] Non fatal acute MI 0.00 [0.00; NaN] Stroke (fatal & non fatal) NaN [NaN; NaN] Death from CHD NaN [NaN; NaN] death, MI and stroke - 1 month 0.00 [0.00; NaN] |
| L-CAD, 2000 | pravastatin vs usual care | Revascularisation 0.40 [0.16; 1.00] | | Death 0.80 [0.05; 12.51] fatal MI NaN [NaN; NaN] Non fatal acute MI NaN [NaN; NaN] Stroke (fatal & non fatal) NaN [NaN; NaN] Death from CHD NaN [NaN; NaN] Major cardiovascular events 0.80 [0.05; 12.51] death, MI and stroke - 4 month 0.80 [0.05; 12.51] death, MI and stroke - 1 month ∞ [NaN; ∞] |
| PAIS, 2001 | pravastatin vs placebo | | | fatal MI 1.96 [0.18; 20.92] death, MI and stroke - 4 month 0.98 [0.26; 3.70] death, MI and stroke - 1 month 0.65 [0.11; 3.74] |
| PTT, 2002 | pravastatin vs usual care | death, MI and stroke - 1 month 0.31 [0.11; 0.89] | | fatal MI 0.00 [0.00; NaN] death, MI and stroke - 4 month 0.31 [0.07; 1.44] |
| PACT, 2004 | pravastatin vs placebo | Non fatal acute MI 0.09 [0.04; 0.23] | | Death 0.69 [0.42; 1.12] fatal MI 0.81 [0.39; 1.67] Stroke (fatal & non fatal) 0.79 [0.31; 2.01] Death from CHD 0.76 [0.46; 1.26] death, MI and stroke - 1 month 0.89 [0.67; 1.18] |
| MEGA, 2006 | pravastatin vs control | coronary deaths 0.53 [0.29; 0.95] coronary events 0.67 [0.49; 0.91] CV events (including revascularization) 0.70 [0.54; 0.90] cardiovascular events 0.75 [0.59; 0.93] | | Pancreatitis 1.03 [0.21; 5.08] all cause deaths 0.71 [0.51; 1.00] cardiovascular death 0.63 [0.30; 1.33] Haemorrhagic strokes 0.90 [0.44; 1.84] MI non fatal 0.55 [0.30; 1.00] stroke (fatal et non fatal) 0.83 [0.57; 1.20] non cardiovascular death 0.74 [0.50; 1.09] incident diabetes 1.07 [0.85; 1.34] |
| GISSI P (diabetic sub group), 2000 | pravastatin vs usual care | | | |
| ALLHAT-LLT (diabetic sub group), 2002 | pravastatin vs usual care | | | Infarctus non mortel et décès coronariens 0.89 [0.73; 1.08] Décès toutes causes 1.03 [0.85; 1.25] Evénement coronarien majeur 0.89 [0.73; 1.08] |
| REGRESS, 1995 | pravastatin vs placebo | CV events (including revascularization) 0.59 [0.42; 0.82] cardiovascular events 0.59 [0.42; 0.82] | | all cause deaths 0.60 [0.20; 1.83] coronary deaths 0.96 [0.06; 15.37] coronary events 0.70 [0.29; 1.73] Rhabdomyolyses NaN [NaN; NaN] Infarctus non mortel et décès coronariens 0.64 [0.29; 1.42] non cardiovascular death 0.96 [0.14; 6.82] |
| PMSG, 1993 | pravastatin vs placebo | | | all cause deaths 0.00 [0.00; NaN] coronary deaths 0.00 [0.00; NaN] Rhabdomyolyses NaN [NaN; NaN] non cardiovascular death NaN [NaN; NaN] |
| CAIUS, 1996 | pravastatin vs placebo | | | coronary deaths ∞ [NaN; ∞] MI non fatal 0.51 [0.05; 5.57] cardiovascular events 1.53 [0.26; 9.03] |
| CARE (elderly subgroup), 1998 | Pravastatin vs placebo | All cause mortality 0.72 [0.55; 0.94] Coronary Heart Disease Mortality 0.56 [0.38; 0.83] Revascularization 0.71 [0.53; 0.93] stroke 0.62 [0.40; 0.97] | | Nonfatal Myocardial Infarction 0.72 [0.49; 1.06] |
| LIPID (elderly sub group), 2001 | Pravastatin vs placebo | All cause mortality 0.80 [0.70; 0.92] Coronary Heart Disease Mortality 0.77 [0.64; 0.94] Revascularization 0.74 [0.62; 0.87] | | Nonfatal Myocardial Infarction 0.81 [0.64; 1.03] stroke 0.89 [0.69; 1.15] |
| PLAC I (elderly sub group), 1995 | Pravastatin vs placebo | | | All cause mortality 0.62 [0.06; 6.59] Coronary Heart Disease Mortality 0.00 [0.00; NaN] Revascularization 0.88 [0.30; 2.59] Nonfatal Myocardial Infarction 0.41 [0.09; 1.94] stroke 0.00 [0.00; NaN] |
| REGRESS (elderly subgroup), 1995 | Pravastatin vs placebo | | | All cause mortality 0.84 [0.05; 13.16] Coronary Heart Disease Mortality NaN [NaN; NaN] Revascularization 0.17 [0.02; 1.40] Nonfatal Myocardial Infarction 0.00 [0.00; NaN] |
| FAST Fukuoka pravastatin, 2002 | pravastatin vs control | | | |
| KLIS, 2000 | pravastatin vs usual care | | | |
| PHYLLIS, 2004 | pravastatin vs placebo | | | |
| PREVEND IT, 2004 | pravastatin vs placebo | | | cardiovascular death 1.00 [0.25; 3.95] MI non fatal 1.87 [0.80; 4.36] cardiovascular events 0.87 [0.48; 1.57] |
| GISSI Prevenzione, 2000 | pravastatin vs usual care | | | Pancreatitis 0.00 [0.00; NaN] all cause deaths 0.82 [0.60; 1.11] fatal stroke 1.00 [0.25; 3.98] stroke (fatal et non fatal) 1.05 [0.56; 1.96] cardiovascular events 0.88 [0.69; 1.12] non cardiovascular death 0.94 [0.46; 1.89] incident diabetes 0.89 [0.67; 1.19] |
| PROSPER (primary prevention subgroup), 2002 | pravastatin vs placebo | | | all cause deaths 0.98 [0.80; 1.20] coronary events 0.91 [0.72; 1.14] stroke (fatal et non fatal) 1.03 [0.73; 1.45] |
| ALLHAT (women subgroup) , 2002 | Pravastatin vs placebo | | | All cause mortality 0.98 [0.83; 1.16] Cv events 1.02 [0.81; 1.28] |
| MEGA (women subgroup) , 2006 | Pravastatin vs placebo | All cause mortality 0.58 [0.35; 0.98] | | cancer 0.54 [0.25; 1.16] Cv events 0.74 [0.49; 1.10] |
| Trial | Treatments | Patients | Method |
|---|
| PROSPER diabetic (sub group), 2002 | pravastatin 40mg daily (n=320) vs. placebo (n=303) | mena and women aged
70–82 years with a history of, or risk factors for, vascular
disease | double blind Parallel groups Sample size: 320/303 Primary endpoint: CV events FU duration: 3.2y mean |
| LIPID (diabetic sub group), 1998 | pravastatin 40 mg daily (n=396) vs. placebo (n=386) | 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 | double blind Parallel groups Sample size: 396/386 Primary endpoint: mortality from coronary heart disease FU duration: mean 6.1y |
| CARE (diabetic sub group), 1998 | pravastatin (n=282) vs. placebo (n=304) | 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 | Parallel groups Sample size: 282/304 Primary endpoint: FU duration: |
| WOSCOPS (diabetic sub group), 1996 | pravastatin 40 mg daily (n=70) vs. placebo (n=0) | 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 | double blind Sample size: 70/0 Primary endpoint: FU duration: mean 4.9y |
| PROSPER, 2002 | pravastatin 40mg daily (n=2891) vs. placebo (n=2913) | men and women aged 70-82 years with a history of, or risk factors for, vascular disease | double blind Parallel groups Sample size: 2891/2913 Primary endpoint: death, MI , stroke FU duration: 3.2 years |
| ALLHAT, 2002 | pravastatin 40mg/d (n=5170) vs. usual care (n=5185) factorial design with 4 antihypertensive treament (amlodipine, lisinopril, doxazosin compared with chlorthalidone) | aged 55 years or older, moderately hypercholesterolemic, hypertensive participants with at least 1 additional CHD risk factor | open Factorial plan Sample size: 5170/5185 Primary endpoint: all cause death FU duration: 4.8 years |
| PLAC I, 1995 | pravastatin 40mg daily (n=206) vs. placebo (n=202) | men and women with coronary artery disease and mild to moderate elevations in cholesterol levels | double blind Parallel groups Sample size: 206/202 Primary endpoint: Atherosclerosis progression FU duration: 3 y |
| PLAC II, 1995 | pravastatin 20-40mg daily (n=75) vs. placebo (n=76) | coronary patients (men and women ) | double blind Parallel groups Sample size: 75/76 Primary endpoint: carotid artery intimal-medial thickness FU duration: 3 y |
| PACT, 2004 | pravastatin initiated within 24 hours of onset of synmptoms and for 4 weeks (n=1710) vs. placebo (n=1689) | patients with unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction <24 hours | double blind Parallel groups Sample size: 1710/1689 Primary endpoint: death, recurrence of MI, or rehospitalisation for unstable angina FU duration: 30 days |
| KAPS, 1995 | pravastatin 40mg/d (n=224) vs. placebo (n=223) | Hypercholesterolemics men with serum LDL-C > or = 4.0 mmol/L and total cholesterol < 7.5 mmol/L | double blind Parallel groups Sample size: 224/223 Primary endpoint: rate of carotid atherosclerotic progression FU duration: 3 years |
| LIPID, 1998 | pravastatin 40 mg/d (n=4512) vs. placebo (n=4502) | patients with previous myocardial infarction or unstable angina and a baseline plasma cholesterol concentration of 4.0-7.0 mmol/L | double blind Parallel groups Sample size: 4512/4502 Primary endpoint: CHD death FU duration: 6.1 years |
| CARE, 1996 | pravastatin 40 mg/d (n=2081) vs. placebo (n=2078) | 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 | double blind Parallel groups Sample size: 2081/2078 Primary endpoint: coronary events FU duration: 5 years |
| WOSCOPS, 1995 | pravastatine 40 mg daily (n=3302) vs. placebo (n=3293) | 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) | double blind Parallel groups Sample size: 3302/3293 Primary endpoint: coronary events (CHD death, MI) FU duration: 4.9 years |
| LAMIL, 1997 | Pravastatin, 10-20 mg (starting at D3) (n=36) vs. Placebo (n=33) | patients suffering an acute myocardial infarction | double blind Parallel groups Sample size: 36/33 Primary endpoint: FU duration: 1 and 3 months |
| RECIFE, 1999 | Pravastatin, 40 mg (n=30) vs. Placebo (n=30) | 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 Parallel groups Sample size: 30/30 Primary endpoint: none defined FU duration: 1.5 months |
| L-CAD, 2000 | Pravastatin, 20-40 mg (strating on average at D6) (n=70) vs. Usual care (n=56) | patients with acute coronary syndrome | open Parallel groups Sample size: 70/56 Primary endpoint: death, MI, stroke, coronary intervention, PVD FU duration: 1, 4, and 6 months |
| PAIS, 2001 | Pravastatin, 40 mg (initiated within 48 hours of hospital admission) (n=50) vs. Placebo (n=49) | patients with acute coronary syndromes | double blind Parallel groups Sample size: 50/49 Primary endpoint: FU duration: 1 and 3 months |
| PTT, 2002 | Pravastatin, 40 mg (n=79) vs. Usual care (n=85) | patients who underwent coronary balloon angioplasty of the infarct-related artery during the first month of acute myocardial infarction | open Parallel groups Sample size: 79/85 Primary endpoint: FU duration: 1 and 6 months |
| PACT, 2004 | Pravastatin, 20-40 mg within 24 hours of the onset of symptoms in (n=1710) vs. Placebo (n=1698) | patients with unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction within 24 hours of the onset of symptoms | double blind Parallel groups Sample size: 1710/1698 Primary endpoint: death, recurrence of MI, or rehospital for unstable angina FU duration: 1 months |
| MEGA, 2006 | pravastatin 10 mg daily (20 mg per day if the total cholesterolconcentration did not decrease to 5·69 mmol/L or less) (n=3866) vs. control (n=3966) | patients with hypercholesterolaemia (total cholesterol 5·69–6·98 mmol/L) and no history of coronary heart disease or stroke | open, blind assessment Parallel groups Sample size: 3866/3966 Primary endpoint: CHD events FU duration: 5.3 y |
| GISSI P (diabetic sub group), 2000 | pravastatin 20 mg daily (n=-9) vs. usual care (n=-9) | recent acute myocardial infarction patients (< or = 6 months) with total blood cholesterol > or = 200 mg/dl | open Sample size: -9/-9 Primary endpoint: FU duration: median 24.3 months |
| ALLHAT-LLT (diabetic sub group), 2002 | pravastatin (n=1855) vs. usual care (n=1783) | 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 | open Parallel groups Sample size: 1855/1783 Primary endpoint: FU duration: |
| REGRESS, 1995 | pravastatin 40 mg daily (n=450) vs. placebo (n=435) | symptomatic men with normal to moderately elevated serum cholesterol levels | double blind Parallel groups Sample size: 450/435 Primary endpoint: change in average mean segment diameter FU duration: 2 years |
| PMSG, 1993 | pravastatin 20 mg once daily (n=530) vs. placebo (n=532) | 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 | double blind Parallel groups Sample size: 530/532 Primary endpoint: not defined FU duration: 26 weeks |
| CAIUS, 1996 | pravastatin 40mg/d (n=151) vs. placebo (n=154) | asymptomatic patients with hypercholesterolemia and at least one 1.3 < IMT < 3.5 mm in the carotid arteries | double blind Parallel groups Sample size: 151/154 Primary endpoint: carotid intima-media thickness FU duration: 3 years |
| CARE (elderly subgroup), 1998 | Pravastatin 40mg (n=640) vs. (n=643) | MI 3–20 months, subgroup of age 65-75 y | double blind parallel groups Sample size: 640/643 Primary endpoint: FU duration: 5.0y |
| LIPID (elderly sub group), 2001 | Pravastatin 40mg (n=1741) vs. (n=1773) | MI or unstable angina, subgroup of age 65-75 y | double blind parallel groups Sample size: 1741/1773 Primary endpoint: FU duration: 6.1y |
| PLAC I (elderly sub group), 1995 | Pravastatin 40mg (n=42) vs. (n=52) | Angiographic CAD or recent MI, subgroup of age 65-75 y | double blind parallel groups Sample size: 42/52 Primary endpoint: FU duration: 2.3y |
| REGRESS (elderly subgroup), 1995 | Pravastatin 40mg (n=75) vs. (n=63) | Angiographic CAD, subgroup of age 65-70 y | double blind parallel groups Sample size: 75/63 Primary endpoint: FU duration: 2.0y |
| FAST Fukuoka pravastatin, 2002 | pravastatin 10 mg/day (n=83) vs. control group (diet alone) (n=81)
| asymptomatic hypercholesterolemic patients
| open Sample size: 83/81 Primary endpoint: carotid intima-media thickness FU duration: 2 years
|
| KLIS, 2000 | pravastatin 10-20 mg/day (n=3061) vs. conventional treatment (n=2579) | Japanese men aged 45-74 years with serum total cholesterol of > or = 220 mg/dl (5.69 mmol/l), primary prevenion | open Parallel groups Sample size: 3061/2579 Primary endpoint: coronary events FU duration: 5 years |
| PHYLLIS, 2004 | pravastatin (40 mg per day) (n=508) vs. placebo (n=0) | hypertensive, hypercholesterolemic patients with asymptomatic carotid atherosclerosis | double-blind Factorial plan Sample size: 508/0 Primary endpoint: intima-media thickness FU duration: 2.6 y |
| PREVEND IT, 2004 | pravastatin 40 mg daily (n=433) vs. placebo (n=431) factorial design with 2nd treatment fosinopril 20 mg | subjects with microalbuminuria | double blind Factorial plan Sample size: 433/431 Primary endpoint: cardiovascular mortality and hospitalization for cardiovascular morbidity FU duration: 46 months |
| GISSI Prevenzione, 2000 | low-dose pravastatin regimen 20 mg daily (n=2138) vs. control (n=2133) | 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 | open Parallel groups Sample size: 2138/2133 Primary endpoint: total mortality, MI, stroke FU duration: 23 months (mean) |
| PROSPER (primary prevention subgroup), 2002 | pravastatin 40mg/d (n=1584) vs. placebo (n=1654)
| men and women aged 70-82 years with a history of, or risk factors for, vascular disease; primary prevention subgroup
| double blind Parallel groups Sample size: 1584/1654 Primary endpoint: FU duration: 3.2 years
|
| ALLHAT (women subgroup) , 2002 | Pravastatin 40 mg daily (n=2511) vs. control (n=2540) | 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 | open Parallel groups Sample size: 2511/2540 Primary endpoint: FU duration: 4.8 y |
| MEGA (women subgroup) , 2006 | Pravastatin 10–20 mg daily (n=2638) vs. control (n=2718) | patients with hypercholesterolaemia (total cholesterol 5.69-6.98 mmol/L) and no history of coronary heart disease or stroke- subgroup of women | open Parallel groups Sample size: 2638/2718 Primary endpoint: coronary heart disease FU duration: 5.3 y |
