| pathology | Benefit (demonstrated or suggested) and harm | | | |
|---|
| acute coronary syndrome | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PROVE IT - TIMI 22, 2004 | vs placebo | Major cardiovascular events 0.76 [0.66; 0.88] | | Death 0.72 [0.50; 1.03] | | MIRACL, 2001 | vs placebo | Non fatal stroke 0.41 [0.19; 0.89] Recurrent ischaemia 0.74 [0.57; 0.95] | | Death 0.95 [0.68; 1.32] fatal MI 0.95 [0.49; 1.84] Revascularisation 1.02 [0.87; 1.20] Non fatal acute MI 0.90 [0.69; 1.17] Death or MI 0.92 [0.75; 1.13] Stroke (fatal & non fatal) 0.50 [0.25; 1.00] Death from CHD 0.86 [0.59; 1.23] Major cardiovascular events 0.92 [0.75; 1.13] CABG 0.97 [0.75; 1.25] PTCA 1.06 [0.85; 1.31] death, MI and stroke - 4 month 0.89 [0.73; 1.09] death, MI and stroke - 1 month 1.06 [0.81; 1.39] | | Colivicchi, 2002 | vs placebo | | | Death 0.77 [0.18; 3.22] fatal MI 0.68 [0.12; 3.88] Revascularisation NaN [NaN; NaN] Non fatal acute MI 0.44 [0.12; 1.58] Stroke (fatal & non fatal) 0.51 [0.05; 5.43] Death from CHD 0.68 [0.12; 3.88] Major cardiovascular events 0.57 [0.21; 1.55] death, MI and stroke - 4 month 0.57 [0.21; 1.55] death, MI and stroke - 1 month 0.00 [0.00; NaN] | | ESTABLISH, 2004 | vs placebo | | | Death 0.00 [0.00; NaN] fatal MI NaN [NaN; NaN] Revascularisation 1.00 [0.42; 2.36] Non fatal acute MI NaN [NaN; NaN] Stroke (fatal & non fatal) NaN [NaN; NaN] Death from CHD NaN [NaN; NaN] Major cardiovascular events 0.00 [0.00; NaN] death, MI and stroke - 4 month 0.00 [0.00; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| PROVE IT - TIMI 22, 2004 | 80 mg of atorvastatin daily (intensive therapy). (n=2099) vs. 40 mg of pravastatin daily (standard therapy) (n=2063) | patients who had been hospitalized for an acute coronary syndrome
within the preceding 10 days | double blind Parallel groups Sample size: 2099/2063 Primary endpoint: death, MI, unstable angina, revascularization, stroke FU duration: 24 mo (18-36 mo) | | MIRACL, 2001 | Atorvastatin, 80 mg (early initiation) (n=1538) vs. Placebo (n=1548) | unstable angina or non–Q-wave acute MI | Double blind Parallel groups Sample size: 1538/1548 Primary endpoint: death, MI, recurrent ischemia requiring hospitalization FU duration: 1 and 4 months | | Colivicchi, 2002 | Atorvastatin, 80 mg daily early initiation (n=40) vs. Usual care (n=41) | unstable angina pectoris or non-Q-wave myocardial infarction | open Parallel groups Sample size: 40/41 Primary endpoint: cardiac death, MI, objective recurrent ischemia FU duration: 1, 3, and 6 months | | ESTABLISH, 2004 | Atorvastatin, 20 mg early initiation (n=35) vs. Usual care (n=35) | patients with ACS undergoing emergency coronary angiography and percutaneous coronary intervention | open Parallel groups Sample size: 35/35 Primary endpoint: none defined FU duration: 1, 4, and 6 months |
|
| acute myocardial infarction | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PROVE-IT, 2004 | vs pravastatin | CV events (including revascularization) 0.76 [0.66; 0.88] | | Pancreatitis 0.98 [0.06; 15.70] adverse events 1.23 [0.87; 1.74] Rhabdomyolyses NaN [NaN; NaN] stroke (fatal et non fatal) 1.18 [0.62; 2.24] Infarctus non mortel et décès coronariens 0.85 [0.69; 1.06] |
| Trial | Treatments | Patients | Method |
|---|
| PROVE-IT, 2004 | atorvastatin 80 mg daily (n=2099) vs. Pravastatin 40 mg (n=2063) factorial design with gatifloxacin
or placebo | acute myocardial
infarction (with or without electrocardiographic
evidence of ST-segment elevation) or highrisk
unstable angina) in the preceding 10 days | double blind Parallel groups Sample size: 2099/2063 Primary endpoint: Cardiac events FU duration: 2 years |
|
| aortic stenosis | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| SALTIRE, 2005 | vs placebo | | | CV detah, aortic replacement, hospitalization for severe aortic stenosis 0.63 [0.34; 1.16] CV death 1.01 [0.21; 4.86] Aortic-valve replacement 0.59 [0.30; 1.15] Death from any cause 0.61 [0.15; 2.46] Hospitalization for severe aortic stenosis 0.61 [0.15; 2.46] |
| Trial | Treatments | Patients | Method |
|---|
| SALTIRE, 2005 | atorvastatin 80mg daily (n=77) vs. placebo (n=78) | patients with calcific aortic stenosis | double blind Parallel groups Sample size: 77/78 Primary endpoint: aortic-jet velocity and aortic-valve calcium score FU duration: 25 mo (7-36) |
|
| atrial fibrillation | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Almroth, 2009 | vs placebo | AF recurrence 0.62 [0.47; 0.81] | | | | MIRACL (sub-group) (Schwartz), 2004 | vs placebo | AF recurrence 0.73 [0.58; 0.91] | | | | Ozaydin, 2006 | vs placebo | AF recurrence 0.27 [0.09; 0.86] | | | | Dernellis, 2006 | vs placebo | AF recurrence 0.39 [0.25; 0.60] | | | | ARMYDA-3 (AF ancillary study), 2006 | vs placebo | AF 0.61 [0.45; 0.84] | | | | Chello, 2006 | vs placebo | | | AF 0.40 [0.09; 1.83] | | MIRACL (AF ancillary study), 2001 | vs placebo | | | AF 1.10 [0.63; 1.93] |
| Trial | Treatments | Patients | Method |
|---|
| Almroth, 2009 | atorvastatin 80 mg daily (n=118) vs. placebo (n=116) | patients with persistent atrial fibrillation undergoing electrical cardioversion | double blind Parallel groups Sample size: 118/116 Primary endpoint: FU duration: 12 patients were excluded after randomization | | MIRACL (sub-group) (Schwartz), 2004 | atorvastatin 80 mg (n=118) vs. placebo (n=108) | Acute coronary syndrome | double blind Sample size: 118/108 Primary endpoint: FU duration: 16 weeks | | Ozaydin, 2006 | atorvastatin 10 mg (n=24) vs. standard therapy (n=24) | Persistent AF and scheduled EC | open Sample size: 24/24 Primary endpoint: recurrence of AF FU duration: 3 months | | Dernellis, 2006 | atorvastatin 20–40 mg (n=40) vs. placebo (n=40) | Paroxysmal AF with CRP between 0.8 and 13 mg/L | NA Sample size: 40/40 Primary endpoint: FU duration: 4–6 months | | ARMYDA-3 (AF ancillary study), 2006 | atorvastatin 40mg daily (n=101) vs. placebo (n=99) | patients with scheduled cardiac surgery without history of AF | Sample size: 101/99 Primary endpoint: post-operative AF 5 min FU duration: 30 days | | Chello, 2006 | atorvastatin 20mg daily (n=20) vs. placebo (n=20) | patients with scheduled coronary bypass surgery | double-blind Parallel groups Sample size: 20/20 Primary endpoint: FU duration: 3 weeks | | MIRACL (AF ancillary study), 2001 | atorvastatin 80mg daily (n=1421) vs. placebo (n=1440) | Acute coronary syndrome; subgroup without history of AF | double-blind Parallel groups Sample size: 1421/1440 Primary endpoint: FU duration: 16 weeks |
|
| CABG surgery | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Chello et al., 2006 | vs placebo | | | all-cause mortality NaN [NaN; NaN] Stroke NaN [NaN; NaN] MI NaN [NaN; NaN] atrial fibrillation 0.40 [0.09; 1.83] | | Patti et al., 2006 | vs placebo | atrial fibrillation 0.61 [0.45; 0.84] | | all-cause mortality 0.98 [0.14; 6.82] MI 0.98 [0.20; 4.74] |
| Trial | Treatments | Patients | Method |
|---|
| Chello et al., 2006 | preoperative atorvastatin 20 mg/d, started 3 wks before surgery (n=20) vs. placebo (n=20) | elective CABG | double blind Sample size: 20/20 Primary endpoint: FU duration: 7 days | | Patti et al., 2006 | preoperative atorvastatin 40 mg/d, starting 7 days before operation (n=101) vs. placebo (n=99) | patients undergoing elective cardiac surgery with cardiopulmonary bypass, without previous statin treatment or history of AF | double blind Sample size: 101/99 Primary endpoint: FU duration: 30 days |
|
| cardiovascular prevention | superior to placebo in terms of CV events (including revascularization) in CARDS, 2004 (diabetic patients) superior to placebo in terms of coronary events in ASCOT, 2003 (at risk hypertensive patients) superior to placebo in terms of cardiovascular events in TNT, 2005 (secondary prevention patients) inferior to placebo in terms of AST >3 x ULN in TNT, 2005 (secondary prevention patients) inferior to placebo in terms of ALT >3 x ULN in TNT, 2005 (secondary prevention patients) inferior to placebo in terms of adverse events in TNT, 2005 (secondary prevention patients) inferior to placebo in terms of Myopathies in TNT, 2005 (secondary prevention patients) inferior to placebo in terms of adverse events in IDEAL, 2005 (secondary prevention patients) inferior to placebo in terms of Myopathies in IDEAL, 2005 (secondary prevention patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ASCOT (diabetics sub group), 2003 | vs placebo | | | Critère de jugement principal de l'étude 0.84 [0.55; 1.28] Infarctus non mortel et décès coronariens 0.84 [0.55; 1.28] AVC 0.67 [0.41; 1.08] Cv events (CV death, MI, stroke) 0.84 [0.55; 1.28] | | vs placebo | | | | | REVERSAL, 2004 | vs placebo | | | 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] | | CARDS, 2004 | 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] | | ASCOT, 2003 | 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] | | PROVE-IT, 2004 | vs placebo | CV events (including revascularization) 0.76 [0.66; 0.88] | | Pancreatitis 0.98 [0.06; 15.70] adverse events 1.23 [0.87; 1.74] Rhabdomyolyses NaN [NaN; NaN] stroke (fatal et non fatal) 1.18 [0.62; 2.24] Infarctus non mortel et décès coronariens 0.85 [0.69; 1.06] | | AVERT, 1999 | vs placebo | | | 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] | | Deutsche Diabetes Dialyse Studie (4D), 2005 | vs placebo | coronary events 0.86 [0.74; 0.99] | | CV events 0.96 [0.83; 1.10] all cause death 0.95 [0.85; 1.07] Cardiovascular death 0.83 [0.67; 1.03] cardiovascular death, CV events (nonfatal MI, or nonfatal stroke) 0.96 [0.83; 1.10] Noncardiovascular death 0.97 [0.80; 1.18] | | PROVE IT - TIMI 22, 2004 | vs placebo | Major cardiovascular events 0.76 [0.66; 0.88] | | Death 0.72 [0.50; 1.03] | | MIRACL, 2001 | vs placebo | Non fatal stroke 0.41 [0.19; 0.89] Recurrent ischaemia 0.74 [0.57; 0.95] | | Death 0.95 [0.68; 1.32] fatal MI 0.95 [0.49; 1.84] Revascularisation 1.02 [0.87; 1.20] Non fatal acute MI 0.90 [0.69; 1.17] Death or MI 0.92 [0.75; 1.13] Stroke (fatal & non fatal) 0.50 [0.25; 1.00] Death from CHD 0.86 [0.59; 1.23] Major cardiovascular events 0.92 [0.75; 1.13] CABG 0.97 [0.75; 1.25] PTCA 1.06 [0.85; 1.31] death, MI and stroke - 4 month 0.89 [0.73; 1.09] death, MI and stroke - 1 month 1.06 [0.81; 1.39] | | TNT, 2005 | vs placebo | 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 | vs placebo | 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] | | SPARCL, 2006 | vs placebo | Major coronary event 0.68 [0.51; 0.89] Fatal stroke 0.59 [0.36; 0.97] Nonfatal or fatal stroke 0.85 [0.73; 0.99] Major cardiovascular event 0.82 [0.72; 0.94] Stroke or TIA 0.79 [0.70; 0.89] TIA 0.74 [0.60; 0.90] | | All cause death 1.02 [0.85; 1.23] cardiovascular death 0.80 [0.59; 1.07] Nonfatal stroke 0.88 [0.75; 1.04] | | Colivicchi, 2002 | vs placebo | | | Death 0.77 [0.18; 3.22] fatal MI 0.68 [0.12; 3.88] Revascularisation NaN [NaN; NaN] Non fatal acute MI 0.44 [0.12; 1.58] Stroke (fatal & non fatal) 0.51 [0.05; 5.43] Death from CHD 0.68 [0.12; 3.88] Major cardiovascular events 0.57 [0.21; 1.55] death, MI and stroke - 4 month 0.57 [0.21; 1.55] death, MI and stroke - 1 month 0.00 [0.00; NaN] | | ESTABLISH, 2004 | vs placebo | | | Death 0.00 [0.00; NaN] fatal MI NaN [NaN; NaN] Revascularisation 1.00 [0.42; 2.36] Non fatal acute MI NaN [NaN; NaN] Stroke (fatal & non fatal) NaN [NaN; NaN] Death from CHD NaN [NaN; NaN] Major cardiovascular events 0.00 [0.00; NaN] death, MI and stroke - 4 month 0.00 [0.00; NaN] | | ASPEN, 2006 | 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] | | Vascular basis, 2005 | vs placebo | | | 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 | vs placebo | 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] | | Strey, 2005 | vs placebo | | | | | TNT (diabetic sub group), 2006 | vs placebo | AVC 0.70 [0.50; 0.98] Cv events (CV death, MI, stroke) 0.77 [0.61; 0.97] | | Décès toutes causes 1.10 [0.82; 1.49] Evénement coronarien majeur 0.82 [0.62; 1.08] | | ASPEN, 2006 | vs placebo | | | Infarctus non mortel et décès coronariens 0.74 [0.51; 1.05] Décès toutes causes 1.02 [0.74; 1.41] Décès cardiovasculaires 1.02 [0.65; 1.59] AVC 0.89 [0.56; 1.40] Cv events (CV death, MI, stroke) 0.91 [0.75; 1.11] | | GREACE, 2002 | vs placebo | 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 | vs placebo | | | | | ASPEN (primary prevention sub group), 2006 | vs placebo | | | all cause deaths 1.06 [0.70; 1.60] coronary events 0.97 [0.75; 1.26] cardiovascular death 1.25 [0.69; 2.26] stroke (fatal et non fatal) 0.92 [0.55; 1.54] cardiovascular events 0.97 [0.75; 1.26] non cardiovascular death 0.90 [0.49; 1.63] | | SALTIRE, 2005 | vs placebo | | | CV detah, aortic replacement, hospitalization for severe aortic stenosis 0.63 [0.34; 1.16] CV death 1.01 [0.21; 4.86] Aortic-valve replacement 0.59 [0.30; 1.15] Death from any cause 0.61 [0.15; 2.46] Hospitalization for severe aortic stenosis 0.61 [0.15; 2.46] | | ASCOT (women subgroup) , 2003 | vs placebo | | | CHD events 1.10 [0.57; 2.10] Cv events 1.10 [0.57; 2.10] | | macin, 2005 | vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| ASCOT (diabetics sub group), 2003 | 10 mg atorvastatin (n=1258) vs. placebo (n=1274) | hypertensive patients with no
history of coronary heart disease (CHD) but at least three cardiovascular risk factors | Sample size: 1258/1274 Primary endpoint: FU duration: | | Mohler III, 2003 | Atorvastatine: 10 mg/ jour ou 80 mg/ jour pendant 12 mois (groupes 1 et 2). (n=240) vs. placebo (n=114) | Stade de la madie : II , stable pendant au moins 6 mois. 364 patients randomisés mais 10 patients exclus après fermeture d'un centre | Double aveugle Parallel groups Sample size: 240/114 Primary endpoint: Durée de marche ( maximale, sans douleur) sur tapis roulant. FU duration: 1 an | | 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 | | 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 | | 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
| | PROVE-IT, 2004 | atorvastatin 80 mg daily (n=2099) vs. Pravastatin 40 mg (n=2063) factorial design with gatifloxacin
or placebo | acute myocardial
infarction (with or without electrocardiographic
evidence of ST-segment elevation) or highrisk
unstable angina) in the preceding 10 days | double blind Parallel groups Sample size: 2099/2063 Primary endpoint: Cardiac events FU duration: 2 years | | 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 | | Deutsche Diabetes Dialyse Studie (4D), 2005 | atorvastatin 20mg daily (n=619) vs. matching placebo (n=636) | patients with type 2 diabetes mellitus on maintenance hemodialysis | double blind Parallel groups Sample size: 619/636 Primary endpoint: cardiac death, stroke, MI FU duration: 4 y (median) | | PROVE IT - TIMI 22, 2004 | 80 mg of atorvastatin daily (intensive therapy). (n=2099) vs. 40 mg of pravastatin daily (standard therapy) (n=2063) | patients who had been hospitalized for an acute coronary syndrome
within the preceding 10 days | double blind Parallel groups Sample size: 2099/2063 Primary endpoint: death, MI, unstable angina, revascularization, stroke FU duration: 24 mo (18-36 mo) | | MIRACL, 2001 | Atorvastatin, 80 mg (early initiation) (n=1538) vs. Placebo (n=1548) | unstable angina or non–Q-wave acute MI | Double blind Parallel groups Sample size: 1538/1548 Primary endpoint: death, MI, recurrent ischemia requiring hospitalization FU duration: 1 and 4 months | | 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 | | SPARCL, 2006 | atorvastatin 80mg daily (n=2365) vs. placebo (n=2366) | patients who had had a stroke or TIA within one to
six months before study entry, had low-density lipoprotein (LDL) cholesterol levels
of 2.6 to 4.9 mmol per liter, and had no known coronary
heart disease | double blind Parallel groups Sample size: 2365/2366 Primary endpoint: nonfatal or fatal stroke FU duration: 4.9y (median) | | Colivicchi, 2002 | Atorvastatin, 80 mg daily early initiation (n=40) vs. Usual care (n=41) | unstable angina pectoris or non-Q-wave myocardial infarction | open Parallel groups Sample size: 40/41 Primary endpoint: cardiac death, MI, objective recurrent ischemia FU duration: 1, 3, and 6 months | | ESTABLISH, 2004 | Atorvastatin, 20 mg early initiation (n=35) vs. Usual care (n=35) | patients with ACS undergoing emergency coronary angiography and percutaneous coronary intervention | open Parallel groups Sample size: 35/35 Primary endpoint: none defined FU duration: 1, 4, and 6 months | | 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 | | 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 | | 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 | | TNT (diabetic sub group), 2006 | atorvastatin 80 mg daily (n=748) vs. atorvastatin 10 mg daily (n=753) | patients with stable coronary heart disease | double blind Sample size: 748/753 Primary endpoint: major cardiovascular event FU duration: 4.9 y | | ASPEN, 2006 | atorvastatin 10mg daily (n=1211) vs. placebo (n=1199) | patients s with type 2 diabetes and LDL cholesterol levels below contemporary
guideline targets | double blind Parallel groups Sample size: 1211/1199 Primary endpoint: CV death, mI, stroke, recanalization, CABG, worsening FU duration: 4y | | 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 | | ASPEN (primary prevention sub group), 2006 | atorvastatin 10mg (n=959) vs. placebo (n=947)
| subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets; primary prevention subgroup
| double blind Parallel groups Sample size: 959/947 Primary endpoint: cardiovascular events FU duration: 4 year
| | SALTIRE, 2005 | atorvastatin 80mg daily (n=77) vs. placebo (n=78) | patients with calcific aortic stenosis | double blind Parallel groups Sample size: 77/78 Primary endpoint: aortic-jet velocity and aortic-valve calcium score FU duration: 25 mo (7-36) | | ASCOT (women subgroup) , 2003 | Atorvastatin 10 mg daily (n=979) vs. placebo (n=963) | hypertensive patients (aged 40-79 years with at least three other cardiovascular risk factors) - subgroup of women | double-blind Parallel groups Sample size: 979/963 Primary endpoint: non-fatal myocardial infarction and fatal CHD FU duration: 3.3 y | | macin, 2005 | atorvastatin 40 mg daily for 30 days (n=-9) vs. placebo (n=-9) | patients admitted within 48 hours of onset of ACS with CRP levels > or =1.4 mg/dL | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 30 days |
|
| diabetes type 2 | superior to atorvastatin in terms of CV events (including revascularization) in CARDS, 2004 (diabetic patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ASCOT (diabetics sub group), 2003 | vs atorvastatin | | | Critère de jugement principal de l'étude 0.84 [0.55; 1.28] Infarctus non mortel et décès coronariens 0.84 [0.55; 1.28] AVC 0.67 [0.41; 1.08] Cv events (CV death, MI, stroke) 0.84 [0.55; 1.28] | | CARDS, 2004 | vs atorvastatin | 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] | | TNT (diabetic sub group), 2006 | vs atorvastatin | AVC 0.70 [0.50; 0.98] Cv events (CV death, MI, stroke) 0.77 [0.61; 0.97] | | Décès toutes causes 1.10 [0.82; 1.49] Evénement coronarien majeur 0.82 [0.62; 1.08] | | ASPEN, 2006 | vs atorvastatin | | | Infarctus non mortel et décès coronariens 0.74 [0.51; 1.05] Décès toutes causes 1.02 [0.74; 1.41] Décès cardiovasculaires 1.02 [0.65; 1.59] AVC 0.89 [0.56; 1.40] Cv events (CV death, MI, stroke) 0.91 [0.75; 1.11] | | ASPEN (primary prevention sub group), 2006 | vs atorvastatin | | | all cause deaths 1.06 [0.70; 1.60] coronary events 0.97 [0.75; 1.26] cardiovascular death 1.25 [0.69; 2.26] stroke (fatal et non fatal) 0.92 [0.55; 1.54] cardiovascular events 0.97 [0.75; 1.26] non cardiovascular death 0.90 [0.49; 1.63] |
| Trial | Treatments | Patients | Method |
|---|
| ASCOT (diabetics sub group), 2003 | 10 mg atorvastatin (n=1258) vs. placebo (n=1274) | hypertensive patients with no
history of coronary heart disease (CHD) but at least three cardiovascular risk factors | Sample size: 1258/1274 Primary endpoint: FU duration: | | 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 | | TNT (diabetic sub group), 2006 | atorvastatin 80 mg daily (n=748) vs. atorvastatin 10 mg daily (n=753) | patients with stable coronary heart disease | double blind Sample size: 748/753 Primary endpoint: major cardiovascular event FU duration: 4.9 y | | ASPEN, 2006 | atorvastatin 10mg daily (n=1211) vs. placebo (n=1199) | patients s with type 2 diabetes and LDL cholesterol levels below contemporary
guideline targets | double blind Parallel groups Sample size: 1211/1199 Primary endpoint: CV death, mI, stroke, recanalization, CABG, worsening FU duration: 4y | | ASPEN (primary prevention sub group), 2006 | atorvastatin 10mg (n=959) vs. placebo (n=947)
| subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets; primary prevention subgroup
| double blind Parallel groups Sample size: 959/947 Primary endpoint: cardiovascular events FU duration: 4 year
|
|
| heart failure | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Strey, 2005 | vs placebo | | | | | Wojnicz, 2006 | vs placebo | | | hospitalization for heart failure 0.00 [0.00; NaN] All cause death NaN [NaN; NaN] cardiovascular death NaN [NaN; NaN] | | Sola, 2006 | vs placebo | | | hospitalization for heart failure 0.58 [0.26; 1.25] All cause death 1.00 [0.26; 3.79] | | Yamada, 2007 | vs placebo | | | 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 |
|
| hypertension | superior to placebo in terms of coronary events in ASCOT, 2003 (at risk hypertensive patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ASCOT, 2003 | 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
|
|
| percutaneous coronary intervention | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| GAIN, 2001 | vs placebo | | | 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 | vs placebo | Nonfatal MI 0.29 [0.10; 0.84] Stroke 0.29 [0.10; 0.84] | | | | NAPLES II (Briguori), 2009 | vs placebo | 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 | 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 |
|
| peripheral vascular diseases | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Mohler III, 2003 | Atorvastatine: 10 mg/ jour ou 80 mg/ jour pendant 12 mois (groupes 1 et 2). (n=240) vs. placebo (n=114) | Stade de la madie : II , stable pendant au moins 6 mois. 364 patients randomisés mais 10 patients exclus après fermeture d'un centre | Double aveugle Parallel groups Sample size: 240/114 Primary endpoint: Durée de marche ( maximale, sans douleur) sur tapis roulant. FU duration: 1 an |
|
| post myocardial infarction | superior to simvastatin in terms of cardiovascular events in TNT, 2005 (secondary prevention patients) inferior to simvastatin in terms of AST >3 x ULN in TNT, 2005 (secondary prevention patients) inferior to simvastatin in terms of ALT >3 x ULN in TNT, 2005 (secondary prevention patients) inferior to simvastatin in terms of adverse events in TNT, 2005 (secondary prevention patients) inferior to simvastatin in terms of Myopathies in TNT, 2005 (secondary prevention patients) inferior to simvastatin in terms of adverse events in IDEAL, 2005 (secondary prevention patients) inferior to simvastatin in terms of Myopathies in IDEAL, 2005 (secondary prevention patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| REVERSAL, 2004 | vs simvastatin | | | 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 | vs simvastatin | 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 | 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 | vs simvastatin | | | 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 | vs simvastatin | 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 |
|
| post stroke | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| SPARCL, 2006 | vs placebo | Major coronary event 0.68 [0.51; 0.89] Fatal stroke 0.59 [0.36; 0.97] Nonfatal or fatal stroke 0.85 [0.73; 0.99] Major cardiovascular event 0.82 [0.72; 0.94] Stroke or TIA 0.79 [0.70; 0.89] TIA 0.74 [0.60; 0.90] | | All cause death 1.02 [0.85; 1.23] cardiovascular death 0.80 [0.59; 1.07] Nonfatal stroke 0.88 [0.75; 1.04] |
| Trial | Treatments | Patients | Method |
|---|
| SPARCL, 2006 | atorvastatin 80mg daily (n=2365) vs. placebo (n=2366) | patients who had had a stroke or TIA within one to
six months before study entry, had low-density lipoprotein (LDL) cholesterol levels
of 2.6 to 4.9 mmol per liter, and had no known coronary
heart disease | double blind Parallel groups Sample size: 2365/2366 Primary endpoint: nonfatal or fatal stroke FU duration: 4.9y (median) |
|
