| Trial | control | p<0.05 | harm | NS |
|---|
| HPS (diabetic sub group), 2002 | vs placebo | Critère de jugement principal de l'étude 0.81 [0.73; 0.89] Evénement coronarien majeur 0.74 [0.64; 0.86] AVC 0.77 [0.63; 0.95] Cv events (CV death, MI, stroke) 0.81 [0.73; 0.89] | | |
| 4S (diabetic sub group), 1999 | vs placebo | Critère de jugement principal de l'étude 0.63 [0.47; 0.83] Evénement coronarien majeur 0.63 [0.47; 0.83] | | Décès toutes causes 0.79 [0.49; 1.28] |
| vs placebo | | | |
| vs placebo | | | |
| MAAS, 1994 | 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 | 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 | 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] |
| A to Z, 2004 | vs placebo | | | Death 0.90 [0.60; 1.35] fatal MI 0.62 [0.35; 1.11] Revascularisation 0.95 [0.74; 1.21] Non fatal acute MI 0.99 [0.77; 1.29] Stroke (fatal & non fatal) 0.79 [0.48; 1.29] Death from CHD 0.86 [0.57; 1.30] Major cardiovascular events 0.89 [0.77; 1.02] death, MI and stroke - 4 month 0.99 [0.80; 1.22] death, MI and stroke - 1 month 0.93 [0.71; 1.22] |
| Node, 2003 | 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 | vs placebo | | | cardiovascular death 0.26 [0.05; 1.20] non fatal MI 0.45 [0.08; 2.39] |
| Landmesser, 2005 | vs placebo | | | |
| CIS, 1997 | 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] |
| 4S (elderly subgroup), 1997 | vs placebo | All cause mortality 0.68 [0.51; 0.90] Coronary Heart Disease Mortality 0.59 [0.41; 0.83] Revascularization 0.62 [0.45; 0.86] Nonfatal Myocardial Infarction 0.71 [0.55; 0.90] | | |
| HPS (elderly subgroup), 2002 | vs placebo | All cause mortality 0.88 [0.81; 0.95] Coronary Heart Disease Mortality 0.83 [0.75; 0.93] stroke 0.71 [0.61; 0.83] | | |
| HPS (post troke sub group), 2004 | vs placebo | Major cardiovascular event 0.79 [0.66; 0.95] | | Nonfatal or fatal stroke 0.99 [0.76; 1.29] |
| SEARCH, 2010 | vs placebo | 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] |
| HPS (diabetic primary prevention sub group), 2003 | vs placebo | | | |
| SEAS, 2008 | vs placebo | | | CV detah, aortic replacement, hospitalization for severe aortic stenosis 0.92 [0.82; 1.04] Death from any cause 1.03 [0.80; 1.34] Aortic-valve replacement 0.95 [0.82; 1.09] CV death 0.83 [0.57; 1.20] |
| HPS (women subgroup) , 2002 | vs placebo | CHD events 0.76 [0.62; 0.94] | | |
| Trial | Treatments | Patients | Method |
|---|
| HPS (diabetic sub group), 2002 | simvastatin 40mg daily (n=2978) vs. placebo (n=2985) | Men and women diabetes aged about 40–80 years with non-fasting
blood total cholesterol concentrations of at least
3·5 mmol/L (135 mg/dL) | double blind Parallel groups Sample size: 2978/2985 Primary endpoint: FU duration: |
| 4S (diabetic sub group), 1999 | simvastatin (n=251) vs. placebo (n=232) | diabetic men
and women aged 35 to 70 years with previous MI or active,
stable angina pectoris and with serum total cholesterol
level between 5.5 to 8.0 mmol/L and serum
triglyceride level <=2.5 mmol/L | double blind Parallel groups Sample size: 251/232 Primary endpoint: FU duration: 5.4y |
| Mondillo, 2003 | simvastatine: 40 mg/ jour pendant 6 mois. (n=43) vs. placebo (n=43) | Stade de la maladie: II. | Double aveugle Parallel groups Sample size: 43/43 Primary endpoint: périmètre de marche( maximal, sans douleur) FU duration: 6 mois |
| Aronow , 2003 | simvastatine 40 mg/j (n=34) vs. placebo (n=35) | Stade II | Non déterminable Parallel groups Sample size: 34/35 Primary endpoint: périmètre de marche FU duration: 1 an |
| 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 |
| A to Z, 2004 | Simvastatin, 40-80 mg early initiation (n=2265) vs. Placebo (n=2232) | patient with an acute coronary syndrome (ACS) | Double aveugle Parallel groups Sample size: 2265/2232 Primary endpoint: cardiovascular death, MI, rehospitalization for ACS or stroke FU duration: 4 months |
| 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 |
| 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: |
| 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 |
| 4S (elderly subgroup), 1997 | Simvastatin 20-40mg (n=518) vs. (n=503) | MI 6 months or stable angina, subgroup of age 65-70 y | double blind parallel groups Sample size: 518/503 Primary endpoint: FU duration: 5.4y |
| HPS (elderly subgroup), 2002 | Simvastatin 40mg (n=5366) vs. (n=5331) | Vascular disease or diabetes, subgroup of age 65-80 y | double blind parallel groups Sample size: 5366/5331 Primary endpoint: FU duration: 5.0y |
| HPS (post troke sub group), 2004 | simvastatin 40mg daily (n=920) vs. placebo (n=900) | adults with cerebrovascular disease, total cholesterol >=3·5 mmol/L and without coronaro disease (n=1820) | double blind Parallel groups Sample size: 920/900 Primary endpoint: FU duration: |
| 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) |
| 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
|
| SEAS, 2008 | simvastatin 40mg plus ezetimibe 10 mg daily (n=944) vs. placebo (n=929) | patients with mild-tomoderate,
asymptomatic aortic stenosis | double blind Parallel groups Sample size: 944/929 Primary endpoint: aortic-valve and cardiovascular events FU duration: 52.2 mo |
| HPS (women subgroup) , 2002 | Simvastatin 40 mg (n=914) vs. placebo (n=902) | UK adults (aged 40-80 years) with coronary disease,other occlusive arterial disease, or diabetes - subgroup of women without CHD | double blind Parallel groups Sample size: 914/902 Primary endpoint: mortality FU duration: 5 y |
