| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| cardiovascular prevention | atorvastatin | at risk hypertensive | versus placebo or control atorvastatin superior to placebo in terms of coronary events in ASCOT, 2003 (at risk hypertensive patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ASCOT, 2003 | atorvastatin vs placebo | coronary events 0.72 [0.59; 0.87] Demonstrated CV events (including revascularization) 0.80 [0.70; 0.90] stroke (fatal et non fatal) 0.73 [0.56; 0.96] Infarctus non mortel et décès coronariens 0.65 [0.50; 0.83] | | Pancreatitis 0.50 [0.21; 1.16] all cause deaths 0.87 [0.71; 1.05] cardiovascular death 0.90 [0.66; 1.23] Rhabdomyolyses ∞ [NaN; ∞] non cardiovascular death 0.85 [0.66; 1.09] incident diabetes 1.14 [0.89; 1.46] |
| Trial | Treatments | Patients | Method |
|---|
| ASCOT, 2003 | atorvastatin 10mg/d (n=5168) vs. placebo (n=5137)
| hypertensive patients aged 40-79 years with at least three other cardiovascular risk factors
| double blind Parallel groups Sample size: 5168/5137 Primary endpoint: Infractus non mortel et décès coronariens FU duration: 3.3 years
|
|
| cardiovascular prevention | atorvastatin | diabetic | versus placebo or control atorvastatin superior to placebo in terms of CV events (including revascularization) in CARDS, 2004 (diabetic patients) | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CARDS, 2004 | atorvastatin vs placebo | CV events (including revascularization) 0.65 [0.49; 0.84] Demonstrated coronary events 0.65 [0.46; 0.93] MI non fatal 0.60 [0.37; 0.99] stroke (fatal et non fatal) 0.53 [0.31; 0.90] cardiovascular events 0.63 [0.47; 0.86] | | Pancreatitis 1.23 [0.33; 4.59] all cause deaths 0.74 [0.53; 1.02] coronary deaths 0.74 [0.40; 1.36] adverse events 0.94 [0.50; 1.75] cardiovascular death 0.65 [0.36; 1.15] décès par cancer 0.66 [0.38; 1.15] Haemorrhagic strokes NaN [NaN; NaN] fatal stroke 0.14 [0.02; 1.15] Rhabdomyolyses NaN [NaN; NaN] Myopathies 0.99 [0.06; 15.78] | | ASPEN, 2006 | atorvastatin vs placebo | | | Pancreatitis 0.59 [0.14; 2.48] coronary events 0.74 [0.51; 1.05] cardiovascular death 1.02 [0.65; 1.59] CV events (including revascularization) 0.91 [0.75; 1.11] stroke (fatal et non fatal) 0.89 [0.56; 1.40] cardiovascular events 0.91 [0.75; 1.11] |
| Trial | Treatments | Patients | Method |
|---|
| CARDS, 2004 | atorvastatin 10mg/d (n=1429) vs. placebo (n=1412) | 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 Parallel groups Sample size: 1429/1412 Primary endpoint: Ev coronariens aigus, revascularisation ou AVC FU duration: 3.9 years | | ASPEN, 2006 | atorvastatin 10mg (n=1211) vs. placebo (n=1199) | subjects with type 2 diabetes and LDL cholesterol levels below contemporaryguideline targets | double blind Parallel groups Sample size: 1211/1199 Primary endpoint: cardiovascular events FU duration: 4 year |
|
| cardiovascular prevention | atorvastatin | secondary prevention | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| GREACE, 2002 | atorvastatin vs usual care | all cause deaths 0.58 [0.35; 0.95] coronary deaths 0.53 [0.33; 0.86] coronary events 0.49 [0.39; 0.61] stroke (fatal et non fatal) 0.53 [0.32; 0.89] cardiac death 0.58 [0.35; 0.95] | | Pancreatitis NaN [NaN; NaN] Haemorrhagic strokes 1.00 [0.06; 15.96] fatal stroke 0.00 [0.00; NaN] Rhabdomyolyses NaN [NaN; NaN] non cardiovascular death 1.50 [0.25; 8.95] | | Mohler, 2003 | atorvastatin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| GREACE, 2002 | atorvastatin 10-80 mg/d (n=800) vs. usual care (n=800) | patients with established coronary heart disease | open Parallel groups Sample size: 800/800 Primary endpoint: CV events FU duration: 3 years mean | | Mohler, 2003 | atorvastatin (10 mg per day) (n=-9) vs. placebo (n=-9) | patients with intermittent claudication | double blind Sample size: -9/-9 Primary endpoint: FU duration: 12 months |
|
| cardiovascular prevention | atorvastatin | secondary prevention | versus angioplasty No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AVERT, 1999 | atorvastatin high dose vs angioplasty | | | coronary deaths 1.08 [0.07; 17.12] CV events (including revascularization) 0.64 [0.40; 1.04] MI non fatal 0.86 [0.24; 3.16] stroke (fatal et non fatal) NaN [NaN; NaN] cardiac death 1.08 [0.07; 17.12] cardiovascular events 0.64 [0.40; 1.04] |
| Trial | Treatments | Patients | Method |
|---|
| AVERT, 1999 | atorvastatin 80 mg/d (n=164) vs. recommended percutaneous revascularization procedure(angioplasty) followed by usual care, whichcould include lipid-lowering treatment (n=177) | patients referred for percutaneous revascularization, with stable coronary artery disease, relatively normal left ventricular function, asymptomatic or mild-to-moderate angina, and a serum level of low-density lipoprotein (LDL) cholesterol of at least 115 mg per deciliter (3.0 mmol per liter) | open Parallel groups Sample size: 164/177 Primary endpoint: ischemic event FU duration: 1.5 years |
|
| cardiovascular prevention | atorvastatin | secondary prevention | versus statin atorvastatin high dose superior to atorvastatin in terms of cardiovascular events in TNT, 2005 (secondary prevention patients) atorvastatin high dose inferior to atorvastatin in terms of AST >3 x ULN in TNT, 2005 (secondary prevention patients) atorvastatin high dose inferior to atorvastatin in terms of ALT >3 x ULN in TNT, 2005 (secondary prevention patients) atorvastatin high dose inferior to atorvastatin in terms of adverse events in TNT, 2005 (secondary prevention patients) atorvastatin high dose inferior to atorvastatin in terms of Myopathies in TNT, 2005 (secondary prevention patients) atorvastatin high dose inferior to simvastatin in terms of adverse events in IDEAL, 2005 (secondary prevention patients) atorvastatin high dose inferior to simvastatin in terms of Myopathies in IDEAL, 2005 (secondary prevention patients) | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| REVERSAL, 2004 | atorvastatin high dose vs pravastatin | | | adverse events 0.95 [0.54; 1.70] Rhabdomyolyses NaN [NaN; NaN] stroke (fatal et non fatal) 1.00 [0.06; 15.92] Infarctus non mortel et décès coronariens 0.57 [0.17; 1.93] Myopathies NaN [NaN; NaN] | | TNT, 2005 | atorvastatin high dose vs atorvastatin | cardiovascular events 0.79 [0.70; 0.89] Demonstrated coronary events 0.80 [0.70; 0.92] MI non fatal 0.79 [0.67; 0.93] stroke (fatal et non fatal) 0.76 [0.60; 0.96] Infarctus non mortel et décès coronariens 0.80 [0.70; 0.92] | AST >3 x ULN 6.68 [3.32; 13.45] ALT >3 x ULN 6.68 [3.32; 13.45] adverse events 1.36 [1.17; 1.59] Myopathies 6.68 [3.32; 13.45] | CPK >10 x ULN NaN [NaN; NaN] Pancreatitis 0.83 [0.52; 1.31] all cause deaths 1.01 [0.86; 1.18] coronary deaths 0.80 [0.62; 1.03] Haemorrhagic strokes 0.84 [0.43; 1.64] Rhabdomyolyses 0.67 [0.11; 4.00] | | IDEAL, 2005 | atorvastatin high dose vs simvastatin | AST >3 x ULN 0.11 [0.03; 0.48] ALT >3 x ULN 0.12 [0.05; 0.29] MI non fatal 0.83 [0.71; 0.98] | adverse events 2.30 [1.94; 2.71] Myopathies 9.02 [2.09; 38.85] | CPK >10 x ULN NaN [NaN; NaN] Pancreatitis 1.00 [0.48; 2.10] all cause deaths 0.98 [0.85; 1.13] coronary deaths 0.99 [0.80; 1.21] coronary events 0.89 [0.78; 1.01] décès par cancer 0.89 [0.68; 1.16] Rhabdomyolyses 0.67 [0.11; 4.00] stroke (fatal et non fatal) 0.87 [0.70; 1.08] Infarctus non mortel et décès coronariens 0.89 [0.78; 1.01] | | Vascular basis, 2005 | atorvastatin high dose vs lovastatin | | | all cause deaths ∞ [NaN; ∞] CV events (including revascularization) 1.57 [0.59; 4.19] stroke (fatal et non fatal) 0.52 [0.03; 8.27] Infarctus non mortel et décès coronariens 2.09 [0.24; 18.47] | | SAGE, 2007 | atorvastatin high dose vs pravastatin | all cause deaths 0.33 [0.13; 0.83] | | coronary deaths 0.33 [0.07; 1.64] adverse events 1.04 [0.71; 1.53] cardiovascular death 0.40 [0.13; 1.26] décès par cancer 0.00 [0.00; NaN] CV events (including revascularization) 0.72 [0.48; 1.08] MI non fatal 0.94 [0.48; 1.84] Rhabdomyolyses NaN [NaN; NaN] stroke (fatal et non fatal) 0.33 [0.03; 3.19] Infarctus non mortel et décès coronariens 0.81 [0.47; 1.41] Myopathies NaN [NaN; NaN] non cardiovascular death 0.33 [0.07; 1.64] |
| Trial | Treatments | Patients | Method |
|---|
| REVERSAL, 2004 | atorvastatin 80 mg daily (n=327) vs. Pravastatin(40 mg) (n=327) | Chronic coronary artery disease | double blind Parallel groups Sample size: 327/327 Primary endpoint: Percentagechange inatheromavolume FU duration: 1.5 years | | TNT, 2005 | 80 mg of atorvastatin
daily (n=4995) vs. 10 mg of atorvastatin daily (n=5006) | Chronic coronary artery disease LDL cholesterol < 3.4 mmol/L | double blind Parallel groups Sample size: 4995/5006 Primary endpoint: Cardiovascular events FU duration: 4.9 years | | IDEAL, 2005 | atorvastatin 80mg daily (n=4439) vs. simvastatine 20mg/j (n=4449) | 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 guidelines | open Parallel groups Sample size: 4439/4449 Primary endpoint: Cardiac events FU duration: 4.8 years | | Vascular basis, 2005 | atorvastatin (80 mg) with or without vitamin C and E (n=197) vs. low dose lovastatin (5 mg) (n=103) | Chronic coronary artery disease | double blind Parallel groups Sample size: 197/103 Primary endpoint: No. andduration ofischemicepisodes onambulatory ECG FU duration: 1 year | | SAGE, 2007 | atorvastatin 80 mg daily (n=446) vs. pravastatin(40 mg) (n=445) | Chronic coronary artery disease | double blind Parallel groups Sample size: 446/445 Primary endpoint: Total duration of ischemia onambulatoryECG FU duration: 1 years |
|
| cardiovascular prevention | fluvastatin | hypertensive | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| HYRIM, 2005 | fluvastatin vs placebo | | | all cause deaths 0.81 [0.22; 2.97] cardiovascular events 0.74 [0.35; 1.58] |
| Trial | Treatments | Patients | Method |
|---|
| HYRIM, 2005 | fluvastatin 40 mg daily (n=283) vs. placebo (n=285) factorialdesign with 2nd randomization between intensive lifestyle intervention (physical activity and diet) or usual care (treatment of hypertension and other disorders by own private physician). | drug-treated hypertensive men aged 40-74 years with total cholesterol 4.5-8.0 mmol/L, triglycerides <4.5 mmol/L, body mass index 25-35 kg/m2, and a sedentary lifestyle | double blind Factorial plan Sample size: 283/285 Primary endpoint: Carotid IMT FU duration: 4 year |
|
| cardiovascular prevention | fluvastatin | primary prevention | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| BCAPS, 2001 | fluvastatin vs placebo | | | all cause deaths 1.01 [0.33; 3.10] cardiac death 0.50 [0.05; 5.53] non cardiovascular death 1.26 [0.34; 4.66] |
| Trial | Treatments | Patients | Method |
|---|
| BCAPS, 2001 | fluvastatin 40 mg once daily (n=395) vs. placebo (n=398) factorial design of fluvastatin versus placebo and metoprolol CR/XL vs placebo | subjects who had carotid plaque but no symptoms of carotid artery disease | double-blind Factorial plan Sample size: 395/398 Primary endpoint: not unique (IMT) FU duration: 3.0 years |
|
| cardiovascular prevention | fluvastatin | secondary prevention | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| LIPS, 2002 | fluvastatin vs placebo | CV events (including revascularization) 0.80 [0.68; 0.96] | | all cause deaths 0.73 [0.48; 1.10] coronary deaths 0.53 [0.27; 1.04] coronary events 0.69 [0.47; 1.01] Rhabdomyolyses NaN [NaN; NaN] cardiac death 0.53 [0.27; 1.04] Infarctus non mortel et décès coronariens 0.69 [0.47; 1.01] non cardiovascular death 0.86 [0.48; 1.54] | | LCAS, 1997 | fluvastatin vs placebo | | | all cause deaths 0.96 [0.20; 4.67] coronary events 0.62 [0.37; 1.04] Rhabdomyolyses NaN [NaN; NaN] cardiac death ∞ [NaN; ∞] non cardiovascular death 0.64 [0.11; 3.77] | | Riegger et al., 1999 | fluvastatin vs placebo | | | all cause deaths 0.48 [0.09; 2.57] Rhabdomyolyses NaN [NaN; NaN] cardiac death 0.48 [0.09; 2.57] non cardiovascular death NaN [NaN; NaN] | | FLARE, 1999 | fluvastatin vs placebo | | | all cause deaths 0.45 [0.12; 1.71] CV events (including revascularization) 0.97 [0.75; 1.24] MI non fatal 0.31 [0.09; 1.12] Rhabdomyolyses NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| LIPS, 2002 | fluvastatin, 80 mg/d (n=844) vs. placebo (n=833)
| 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 3.5-7.0 mmol/L and with fasting triglyceride levels of less than 4.5 mmol/L
| double blind Parallel groups Sample size: 844/833 Primary endpoint: MACE (cardiac death, MI, reintervention) FU duration: 3.9 years
| | LCAS, 1997 | fluvastatin 20 mg twice daily (n=164) vs. placebo (n=157) | 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 diet | double-blind Parallel groups Sample size: 164/157 Primary endpoint: minimum lumen diameter FU duration: 2.5 years | | Riegger et al., 1999 | fluvastatin 40 mg (o.a.d. or b.i.d.) (n=187) vs. placebo (n=178) | hyperlipidaemic patients with symptomatic, clinically-diagnosed (exercise-ECG) coronary heart disease | double blind Parallel groups Sample size: 187/178 Primary endpoint: FU duration: 1.0 years | | FLARE, 1999 | fluvastatin 40 mg twice daily (n=409) vs. placebo (n=425) | successful coronary balloon angioplasty | double blind Parallel groups Sample size: 409/425 Primary endpoint: angiographic restenosis FU duration: 40 weeks |
|
| cardiovascular prevention | lovastatin | diabetic | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CRISP 20mg, 1994 | lovastatin vs placebo | | | | | CRISP 40mg, 1994 | lovastatin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| CRISP 20mg, 1994 | lovastatin 20mg daily (n=-9) vs. placebo (n=-9) 3 arms placebo, lovastatin 20mg and 40mg | elderly (mean 71y) with low-density lipoprotein cholesterol levels greater than 4.1 and less than 5.7 mmol/L | double blind Parallel groups Sample size: -9/-9 Primary endpoint: changes in blood lipid levels FU duration: 1 years | | CRISP 40mg, 1994 | lovastatin 40 mg daily (n=-9) vs. placebo (n=-9)
| elderly (mean 71y) with low-density lipoprotein cholesterol levels greater than 4.1 and less than 5.7 mmol/L
| double blind Parallel groups Sample size: -9/-9 Primary endpoint: changes in blood lipid levels FU duration: 1 years
|
|
| cardiovascular prevention | lovastatin | primary prevention | versus placebo or control lovastatin superior to placebo in terms of coronary events in AFCAPS/TexCAPS, 1998 (primary prevention patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AFCAPS/TexCAPS, 1998 | lovastatin vs placebo | coronary events 0.76 [0.62; 0.92] Demonstrated Infarctus non mortel et décès coronariens 0.76 [0.62; 0.92] | | Pancreatitis 0.70 [0.27; 1.84] all cause deaths 1.04 [0.76; 1.41] coronary deaths 0.73 [0.34; 1.59] cardiovascular death 0.68 [0.37; 1.26] Rhabdomyolyses 0.50 [0.05; 5.51] stroke (fatal et non fatal) 0.82 [0.41; 1.67] non cardiovascular death 1.21 [0.84; 1.74] incident diabetes 0.98 [0.70; 1.38] |
| Trial | Treatments | Patients | Method |
|---|
| AFCAPS/TexCAPS, 1998 | lovastatin 20-40 mg/d (n=3304) vs. placebo (n=3301)
| 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) levels
| double blind Parallel groups Sample size: 3304/3301 Primary endpoint: major coronary event FU duration: 5.2 years
|
|
| cardiovascular prevention | lovastatin | secondary prevention | versus placebo or control No demonstrated result for efficacy | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CCAIT, 1994 | lovastatin vs placebo | | | all cause deaths 1.01 [0.14; 7.06] coronary deaths 1.98 [0.18; 21.59] MI non fatal 0.84 [0.26; 2.69] non cardiovascular death 0.00 [0.00; NaN] | | MARS, 1993 | lovastatin vs placebo | | | all cause deaths ∞ [NaN; ∞] coronary deaths 0.00 [0.00; NaN] non cardiovascular death ∞ [NaN; ∞] | | Weintraub, 1994 | lovastatin vs placebo | | | non cardiovascular death NaN [NaN; NaN] | | ACAPS, 1994 | lovastatin vs placebo | all cause deaths 0.12 [0.02; 0.99] | | coronary deaths 0.00 [0.00; NaN] cardiovascular death 0.00 [0.00; NaN] MI non fatal 1.00 [0.29; 3.42] Rhabdomyolyses NaN [NaN; NaN] stroke (fatal et non fatal) 0.00 [0.00; NaN] cardiac death 0.00 [0.00; NaN] non cardiovascular death 0.50 [0.05; 5.48] | | Sahni, 1991 | lovastatin vs usual care | | | all cause deaths 0.79 [0.22; 2.83] coronary deaths 0.49 [0.09; 2.62] non cardiovascular death 1.97 [0.18; 21.34] | | CLAPT, 1999 | lovastatin vs usual care | | | all cause deaths 0.00 [0.00; NaN] MI non fatal 0.00 [0.00; NaN] cardiac death 0.00 [0.00; NaN] non cardiovascular death NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| CCAIT, 1994 | lovastatin begun at 20 mg/d and titrated to 40 and 80 mg during the first 16 weeks to attain a fasting low-density lipoprotein (LDL) cholesterol < or = 130 mg/dL (n=165) vs. placebo (n=166)
| patients with diffuse but not necessarily severe coronary atherosclerosis documented on a recent arteriogram and with fasting serum cholesterol between 220 and 300 mg/dL
| double-blind Parallel groups Sample size: 165/166 Primary endpoint: minimum lumen diameter changes FU duration: 2 years
| | MARS, 1993 | lovastatin 80 mg/day (n=123) vs. placebo (n=124)
| patients, 37 to 67 years old, with total cholesterol ranging from 4.92 to 7.64 mmol/L (190 to 295 mg/dL) and angiographically defined coronary artery disease
| double blind Parallel groups Sample size: 123/124 Primary endpoint: change in percent diameter stenosis FU duration: 2.0y
| | Weintraub, 1994 | lovastatin 40 mg orally twice daily (n=203) vs. placebo (n=201)
| patients undergoing PTCA
| double blind Parallel groups Sample size: 203/201 Primary endpoint: FU duration: 0.5 years
| | ACAPS, 1994 | lovastatin 20mg daily (n=460) vs. placebo (n=459) factorial design of warfarin and lovastatin
| men and women, 40 to 79 years old, with early carotid atherosclerosis and moderately elevated LDL cholesterol.
| double blind Factorial plan Sample size: 460/459 Primary endpoint: change in mean maximum intimal-medial thickness FU duration: 2.8 years
| | Sahni, 1991 | lovastatin 20-40mg/d (n=79) vs. conventional therapy alone (n=78) | patients undergoing successful PTCA
| open Parallel groups Sample size: 79/78 Primary endpoint: FU duration: 2 years
| | CLAPT, 1999 | lovastatin begun at 20 mg daily and tritrated up to 80 mg daily (n=112) vs. usual care (n=114) | patients underwenting PTCA | open (blind assessement) Parallel groups Sample size: 112/114 Primary endpoint: mean segment diameter FU duration: 2.0 years |
|
| cardiovascular prevention | pravastatin | at risk hypertensive | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| 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] |
| Trial | Treatments | Patients | Method |
|---|
| 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 |
|
| cardiovascular prevention | pravastatin | diabetic | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PHYLLIS, 2004 | pravastatin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| 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 |
|
| cardiovascular prevention | pravastatin | primary prevention | versus placebo or control pravastatin superior to placebo in terms of coronary events in WOSCOPS, 1995 (primary prevention patients) | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| 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] | | 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] | | 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] | | FAST Fukuoka pravastatin, 2002 | pravastatin vs control | | | | | KLIS, 2000 | pravastatin vs usual care | | | | | 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] |
| Trial | Treatments | Patients | Method |
|---|
| 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 | | 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 | | 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 | | 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 | | 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
|
|
| cardiovascular prevention | pravastatin | secondary prevention | versus placebo or control pravastatin superior to placebo in terms of cardiovascular events in PROSPER, 2002 (secondary prevention patients) pravastatin superior to placebo in terms of coronary deaths in LIPID, 1998 (secondary prevention patients) pravastatin superior to placebo in terms of coronary events in CARE, 1996 (secondary prevention patients) pravastatin inferior to placebo in terms of incident diabetes in PROSPER, 2002 (secondary prevention patients) | 8 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| 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] | | 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] | | 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] | | 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] | | 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] |
| Trial | Treatments | Patients | Method |
|---|
| 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 | | 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 | | 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 | | 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 | | 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) |
|
| cardiovascular prevention | rosuvastatin | diabetic | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| METEOR, 2007 | rosuvastatin vs placebo | | | all cause deaths ∞ [NaN; ∞] coronary deaths NaN [NaN; NaN] cardiovascular death NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| METEOR, 2007 | rosuvastatin 40mg daily (n=702) vs. placebo (n=282) | individuals, with either age (mean, 57 years) as the only coronary heart disease risk factor or a 10-year Framingham risk score of less than 10%, modest CIMT thickening (1.2-<3.5 mm), and elevated LDL cholesterol | double-blind Parallel groups Sample size: 702/282 Primary endpoint: carotid intima-media thickness FU duration: |
|
| cardiovascular prevention | rosuvastatin | primary prevention | versus placebo or control rosuvastatin superior to placebo in terms of CV events (including revascularization) in JUPITER, 2008 (primary prevention patients) rosuvastatin superior to placebo in terms of CV events (including revascularization) in HOPE 3, 2016 (primary prevention patients) rosuvastatin superior to placebo in terms of cardiovascular events in HOPE 3, 2016 (primary prevention patients) rosuvastatin inferior to placebo in terms of incident diabetes in JUPITER, 2008 (primary prevention patients) | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| JUPITER, 2008 | rosuvastatin vs placebo | CV events (including revascularization) 0.57 [0.46; 0.69] Demonstrated all cause deaths 0.80 [0.67; 0.96] coronary events 0.46 [0.30; 0.70] MI non fatal 0.35 [0.22; 0.58] stroke (fatal et non fatal) 0.52 [0.34; 0.78] cardiovascular events 0.53 [0.41; 0.69] venous thromboembolism 0.57 [0.37; 0.86] | incident diabetes 1.26 [1.05; 1.52] | Pancreatitis 1.00 [0.51; 1.96] Haemorrhagic strokes 0.67 [0.24; 1.87] fatal stroke 0.50 [0.13; 2.00] | | HOPE 3, 2016 | rosuvastatin vs placebo | CV events (including revascularization) 0.75 [0.64; 0.88] Demonstrated cardiovascular events 0.76 [0.64; 0.91] Demonstrated coronary events 0.74 [0.58; 0.95] stroke (fatal et non fatal) 0.70 [0.52; 0.95] cardiac death 0.74 [0.58; 0.95] Infarctus non mortel et décès coronariens 0.65 [0.44; 0.95] | | all cause deaths 0.93 [0.80; 1.08] cardiovascular death 0.89 [0.72; 1.11] incident diabetes 1.02 [0.85; 1.23] |
| Trial | Treatments | Patients | Method |
|---|
| JUPITER, 2008 | rosuvastatin 20 mg daily (n=8901) vs. placebo (n=8901) | apparently healthy individuals with low LDL-cholesterol levels of less than 130 mg per deciliter but elevated C-reactive-protein (high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher) | double blind Parallel groups Sample size: 8901/8901 Primary endpoint: MI, stroke, arterial revascularization, hospitalization for unstable angina, cardiovascular death FU duration: median 1.9 year | | HOPE 3, 2016 | rosuvastatin 10 mg per day (n=6361) vs. placebo (n=6344) | subjects who did
not have cardiovascular disease and were at intermediate
risk | double-blind Factorial plan Sample size: 6361/6344 Primary endpoint: death from cardiovascular causes, LI, stroke FU duration: 5.6 years |
|
| cardiovascular prevention | simvastatin | diabetic | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| HPS (diabetic primary prevention sub group), 2003 | simvastatin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| HPS (diabetic primary prevention sub group), 2003 | simvastatin 40 mg/d (n=1455) vs. placebo (n=1457)
| adults (aged 40-80 years) with diabetes (primary prevention subgroup)
| double blind Parallel groups Sample size: 1455/1457 Primary endpoint: All cause death FU duration: 5 years
|
|
| cardiovascular prevention | simvastatin | secondary prevention | versus placebo or control simvastatin superior to placebo in terms of all cause deaths in HPS, 2002 (secondary prevention patients) simvastatin superior to placebo in terms of all cause deaths in 4S, 1994 (secondary prevention patients) | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| MAAS, 1994 | simvastatin vs placebo | | | all cause deaths 0.35 [0.11; 1.09] coronary deaths 0.78 [0.21; 2.86] Rhabdomyolyses NaN [NaN; NaN] non cardiovascular death 0.00 [0.00; NaN] | | HPS, 2002 | simvastatin vs placebo | all cause deaths 0.88 [0.82; 0.94] Demonstrated coronary deaths 0.83 [0.75; 0.92] coronary events 0.74 [0.68; 0.80] cardiovascular death 0.83 [0.76; 0.91] MI non fatal 0.62 [0.55; 0.71] stroke (fatal et non fatal) 0.76 [0.67; 0.86] Infarctus non mortel et décès coronariens 0.74 [0.68; 0.80] | | Pancreatitis 0.80 [0.51; 1.27] décès par cancer 1.04 [0.90; 1.20] Haemorrhagic strokes 0.96 [0.66; 1.41] fatal stroke 0.81 [0.62; 1.05] Rhabdomyolyses 1.67 [0.40; 6.97] Myopathies 2.50 [0.78; 7.97] incident diabetes 1.15 [0.98; 1.35] | | 4S, 1994 | simvastatin vs placebo | all cause deaths 0.71 [0.59; 0.85] Demonstrated coronary deaths 0.59 [0.47; 0.74] coronary events 0.69 [0.62; 0.77] cardiovascular death 0.66 [0.53; 0.81] MI non fatal 0.67 [0.58; 0.77] stroke (fatal et non fatal) 0.71 [0.53; 0.97] cardiac death 0.59 [0.47; 0.74] cardiovascular events 0.74 [0.67; 0.81] | | Pancreatitis 0.71 [0.23; 2.25] décès par cancer 0.94 [0.59; 1.51] Haemorrhagic strokes 0.00 [0.00; NaN] fatal stroke 1.17 [0.54; 2.52] non cardiovascular death 0.94 [0.63; 1.40] incident diabetes 1.03 [0.83; 1.27] | | CIS, 1997 | simvastatin vs placebo | | | all cause deaths 0.24 [0.03; 2.14] coronary deaths 0.48 [0.04; 5.28] coronary events 0.76 [0.41; 1.44] MI non fatal 0.19 [0.02; 1.64] non cardiovascular death 0.00 [0.00; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| MAAS, 1994 | simvastatin 20 mg daily (n=193) vs. placebo (n=188) | patients with coronary heart disease | double blind Parallel groups Sample size: 193/188 Primary endpoint: QCA FU duration: 4 y | | HPS, 2002 | simvastatin 40 mg/d (n=10269) vs. placebo (n=10267) | adults (aged 40-80 years) with coronary disease, other occlusive arterial disease, or diabete | double blind Factorial plan Sample size: 10269/10267 Primary endpoint: all cause death FU duration: 5 years | | 4S, 1994 | simvastatin 20 or 40 mg/d, target CT between 3 et 5.2 mmol/l (n=2221) vs. placebo (n=2223) (37 % des patients à 40 mg/j); simvastatine 10 mg/j pour 2 patients | patients with angina pectoris or previous myocardial infarction and serum cholesterol 5.5-8.0 mmol/L on a lipid-lowering diet | double blind Parallel groups Sample size: 2221/2223 Primary endpoint: all cause death FU duration: 5.4 years | | CIS, 1997 | simvastatin 40 mg (n=129) vs. placebo (n=125) | men with documented coronary artery disease and hypercholesterolaemia | double blind Parallel groups Sample size: 129/125 Primary endpoint: mean change of minimum lumen diameter FU duration: 2.3 years |
|
| cardiovascular prevention | simvastatin | secondary prevention | versus statin No demonstrated result for efficacy simvastatin high dose inferior to simvastatin in terms of Rhabdomyolyses in SEARCH, 2010 (secondary prevention patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| SEARCH, 2010 | simvastatin high dose vs simvastatin | MI non fatal 0.86 [0.75; 0.98] | Rhabdomyolyses 17.67 [5.53; 56.52] | Pancreatitis 0.66 [0.37; 1.17] all cause deaths 1.00 [0.92; 1.08] coronary deaths 1.02 [0.90; 1.16] coronary events 0.97 [0.90; 1.04] cardiovascular death 0.99 [0.89; 1.11] décès par cancer 0.92 [0.78; 1.09] CV events (including revascularization) 0.95 [0.89; 1.01] fatal stroke 0.85 [0.60; 1.21] stroke (fatal et non fatal) 0.91 [0.77; 1.08] cardiac death 1.02 [0.90; 1.16] cardiovascular events 0.95 [0.89; 1.01] non cardiovascular death 1.00 [0.87; 1.14] |
| Trial | Treatments | Patients | Method |
|---|
| SEARCH, 2010 | simvastatin 80 mg daily (n=6031) vs. simvastatin 20mg daily (n=6033) factorial design with folic acid and vitamin B12 | MI survivors | Parallel groups Sample size: 6031/6033 Primary endpoint: coronary death, myocardial infarction, stroke, or arterial revascularisation FU duration: 6.7 years (mean) |
|
| heart failure | atorvastatin | heart failure | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Strey, 2005 | atorvastatin vs placebo | | | | | Wojnicz, 2006 | atorvastatin vs control | | | hospitalization for heart failure 0.00 [0.00; NaN] All cause death NaN [NaN; NaN] cardiovascular death NaN [NaN; NaN] | | Sola, 2006 | atorvastatin vs placebo | | | hospitalization for heart failure 0.58 [0.26; 1.25] All cause death 1.00 [0.26; 3.79] | | Yamada, 2007 | atorvastatin vs control | | | hospitalization for heart failure 0.33 [0.08; 1.45] All cause death 0.00 [0.00; NaN] cardiovascular death 0.00 [0.00; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Strey, 2005 | atorvastatin 40mg (n=24) vs. placebo (n=24) | patients with stable, symptomatic heart failure (New York Heart Association Class II or III) and a left ventricular ejection fraction <40% | Cross over Sample size: 24/24 Primary endpoint: FU duration: 6 weeks | | Wojnicz, 2006 | atorvastatin 40 mg/day (n=36) vs. conventional treatment for heart
failure (n=38) | patients with inflammatory dilated cardiomyopathy (DC) (positive immunohistochemistry results on endomyocardial biopsy) | open Parallel groups Sample size: 36/38 Primary endpoint: FU duration: 6 months | | Sola, 2006 | atorvastatin 20 mg/day (n=54) vs. placebo (n=54) | patients with nonischemic HF and a left ventricular ejection fraction (LVEF) <=35% | double blind Parallel groups Sample size: 54/54 Primary endpoint: FU duration: 1y | | Yamada, 2007 | atorvastatin 10 mg/d (n=19) vs. standard treatment (n=19) | outpatients with mild to moderate CHF and radionuclide left ventricular ejection fraction
(LVEF) <40% | Parallel groups Sample size: 19/19 Primary endpoint: FU duration: mean 2.58y |
|
| heart failure | cerivastatin | heart failure | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Laufs, 2004 | cerivastatin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Laufs, 2004 | cerivastatin 0.4 mg (n=8) vs. placebo (n=7) | patients with heart failure NYHA
II-III caused by non-ischemic dilated
cardiomyopathy | double blind Parallel groups Sample size: 8/7 Primary endpoint: FU duration: mean 20 weeks |
|
| heart failure | rosuvastatin | heart failure | versus placebo or control No demonstrated result for efficacy rosuvastatin inferior to placebo in terms of death or hospitalization for HF in GISSI-HF rosuvastatine, 2008 (heart failure patients) | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CORONA, 2007 | rosuvastatin vs placebo | | | hospitalization for heart failure 0.92 [0.84; 1.01] All cause death 0.95 [0.87; 1.04] coronary event 0.94 [0.85; 1.04] cardiovascular death 1.00 [0.89; 1.11] fatal MI 1.66 [0.73; 3.78] fatal stroke 1.09 [0.67; 1.75] non fatal stroke 0.85 [0.64; 1.12] non fatal MI 0.81 [0.64; 1.03] death from noncardiovascular cause 0.86 [0.69; 1.08] cardiovascular events (fatal and non fatal) 0.94 [0.86; 1.03] incident diabetes 1.13 [0.86; 1.49] | | Krum, 2007 | rosuvastatin vs placebo | | | All cause death 0.77 [0.13; 4.36] | | GISSI-HF rosuvastatine, 2008 | rosuvastatin vs placebo | | death or hospitalization for HF 1.01 [1.01; 1.01] | hospitalization for heart failure 0.99 [0.90; 1.09] All cause death 1.02 [0.93; 1.12] coronary event 0.87 [0.62; 1.22] cardiovascular death 0.98 [0.88; 1.10] fatal MI 0.67 [0.30; 1.48] fatal stroke 1.31 [0.81; 2.12] death from noncardiovascular cause 1.20 [0.96; 1.51] fatal and non fatal stroke 1.24 [0.90; 1.71] fatal and non fatal MI 0.87 [0.62; 1.22] cardiovascular events (fatal and non fatal) 0.98 [0.92; 1.04] incident diabetes 1.08 [0.91; 1.29] |
| Trial | Treatments | Patients | Method |
|---|
| CORONA, 2007 | rosuvastatin 10mg/d (n=2514) vs. placebo (n=2497) | patients at least 60 years of age with NYHA class II, III, or IV ischemic, systolic heart failure | double blind Parallel groups Sample size: 2514/2497 Primary endpoint: cardiovascular death, MI, stroke FU duration: 32.9 months median | | Krum, 2007 | rosuvastatine 40mg/d (n=40) vs. placebo (n=46) | patients with systolic (LVEF<40%) CHF of ischemic or
nonischemic etiology | double blind Parallel groups Sample size: 40/46 Primary endpoint: LVEF by radionuclide ventriculogram FU duration: 6 months | | GISSI-HF rosuvastatine, 2008 | low-dose rosuvastatin 10 mg daily (n=2314) vs. placebo (n=2317) | Patients with NYHA classes II to IV heart failure, whatever the cause and the LVEF
and already receiving optimized recommended therapy with no clear indication or contraindication to cholesterollowering therapy | double blind Parallel groups Sample size: 2314/2317 Primary endpoint: death and death+hospitalization FU duration: 3.9y median (IQR 3-4.4) |
|
| heart failure | simvastatin | heart failure | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Node, 2003 | simvastatin vs placebo | | | hospitalization for heart failure 1.13 [0.07; 17.02] All cause death NaN [NaN; NaN] cardiovascular death NaN [NaN; NaN] | | Hong, 2005 | simvastatin vs control | | | cardiovascular death 0.26 [0.05; 1.20] non fatal MI 0.45 [0.08; 2.39] |
| Trial | Treatments | Patients | Method |
|---|
| Node, 2003 | simvastatin 10mg/d (n=24) vs. placebo (n=27) | patients with symptomatic, nonischemic, dilated cardiomyopathy | Sample size: 24/27 Primary endpoint: FU duration: | | Hong, 2005 | simvastatin (n=106) vs. no treatment (n=96) | patients with ischemic heart failure who underwent percutaneous coronary intervention (PCI) for acute myocardial infarction (left ventricular [LV] ejection fraction <40%) | open Parallel groups Sample size: 106/96 Primary endpoint: none FU duration: 1 year |
|
| heart failure | simvastatin | heart failure | versus ezetimibe No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Landmesser, 2005 | simvastatin vs ezetimibe | | | |
| Trial | Treatments | Patients | Method |
|---|
| Landmesser, 2005 | simvastatin 10mg/d (n=10) vs. ezetimibe 10mg/d (n=10) | patients with chronic heart failure | Sample size: 10/10 Primary endpoint: FU duration: |
|
| percutaneous coronary intervention | atorvastatin | not classified | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| GAIN, 2001 | atorvastatin vs usual care | | | All-cause mortality NaN [NaN; NaN] Cardiovascular mortality NaN [NaN; NaN] Revascularization 0.44 [0.20; 1.01] Nonfatal MI 0.00 [0.00; NaN] Stroke ∞ [NaN; ∞] | | ARMYDA, 2004 | atorvastatin vs placebo | Nonfatal MI 0.29 [0.10; 0.84] Stroke 0.29 [0.10; 0.84] | | | | NAPLES II (Briguori), 2009 | atorvastatin vs control | MI (CK-MB >3x ULN at 6 and 12 hours after PCI) 0.56 [0.40; 0.79] MI (troponin I >3x ULN at 6 and 12 hours after PCI) 0.56 [0.35; 0.91] | | | | ARMYDA-RECAPTURE, 2009 | atorvastatin reload vs placebo | MACE 0.39 [0.16; 0.91] Nonfatal MI 0.41 [0.17; 0.97] | | All-cause mortality 0.00 [0.00; NaN] Revascularization 0.00 [0.00; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| GAIN, 2001 | Atorvastatin 20–40 mg/d 1 d after PCI (n=65) vs. usual care (n=66) | | open Sample size: 65/66 Primary endpoint: FU duration: 12 mo | | ARMYDA, 2004 | atorvastatin 40 mg/day seven days prior to the procedure (n=76) vs. placebo (n=77) | Patients scheduled for elective PCI | double blind Sample size: 76/77 Primary endpoint: FU duration: 1 mo | | NAPLES II (Briguori), 2009 | atorvastatin 80 mg loading dose administered within 24 hours prior to elective PCI (n=338) vs. no statin therapy (n=330) | Patients with coronary artery disease scheduled for elective PCI and not on statin therapy | open Parallel groups Sample size: 338/330 Primary endpoint: periprocedural MI by cardiac enzyme FU duration: 24h | | ARMYDA-RECAPTURE, 2009 | atorvastatin reload (80 mg 12 h before intervention, with a further 40-mg pre-procedural dose) (n=229) vs. placebo (n=228) | patient with long-term atorvastatin treatment thereafter (40 mg/day) undergoing PCI (for stable angina or NSTEMI ACS) | double blind Parallel groups Sample size: 229/228 Primary endpoint: MACE FU duration: 30 days |
|
| percutaneous coronary intervention | fluvastatin | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FLARE, 1999 | fluvastatin vs placebo | | | All-cause mortality 0.45 [0.12; 1.71] Revascularization 1.09 [0.83; 1.43] Nonfatal MI 0.31 [0.09; 1.12] | | LIPS, 2002 | fluvastatin vs placebo | | | All-cause mortality 0.73 [0.48; 1.10] Cardiovascular mortality 0.53 [0.27; 1.04] Revascularization 0.85 [0.71; 1.03] Nonfatal MI 0.78 [0.49; 1.25] Stroke 1.97 [0.18; 21.73] |
| Trial | Treatments | Patients | Method |
|---|
| FLARE, 1999 | Fluvastatin 40 mg twice daily 15–30 d before PCI (n=409) vs. placebo (n=425) | patients undergoing PTCA | double blind Sample size: 409/425 Primary endpoint: angiographic restenosis FU duration: 10 mo | | LIPS, 2002 | Fluvastatin 40 mg twice daily 0–22 d after PCI (n=844) vs. placebo (n=833) | patients with stable or unstable angina or silent ischemia and successful completion of their first PCI | double blind Sample size: 844/833 Primary endpoint: MACE FU duration: 45 mo (median) |
|
| percutaneous coronary intervention | pravastatin | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PREDICT, 1997 | pravastatin vs placebo | | | All-cause mortality 4.01 [0.45; 35.71] Cardiovascular mortality ∞ [NaN; ∞] Revascularization 0.88 [0.66; 1.19] Nonfatal MI 1.00 [0.25; 3.98] Stroke ∞ [NaN; ∞] |
| Trial | Treatments | Patients | Method |
|---|
| PREDICT, 1997 | Pravastatin 40 mg/d 1 d after PCI (n=347) vs. placebo (n=348) | patient undergoing PCI | double blind Sample size: 347/348 Primary endpoint: minimal lumen diameter FU duration: 6 mo |
|
