| cardiovascular prevention | superior to placebo in terms of CV events (including revascularization) in JUPITER, 2008 (primary prevention patients) superior to placebo in terms of CV events (including revascularization) in HOPE 3, 2016 (primary prevention patients) superior to placebo in terms of cardiovascular events in HOPE 3, 2016 (primary prevention patients) inferior to placebo in terms of incident diabetes in JUPITER, 2008 (primary prevention patients) inferior to placebo in terms of death or hospitalization for HF in GISSI-HF rosuvastatine, 2008 (heart failure patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| METEOR, 2007 | vs placebo | | | all cause deaths ∞ [NaN; ∞] coronary deaths NaN [NaN; NaN] cardiovascular death NaN [NaN; NaN] | | JUPITER, 2008 | 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] | | CORONA, 2007 | 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 | vs placebo | | | All cause death 0.77 [0.13; 4.36] | | GISSI-HF rosuvastatine, 2008 | 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] | | AURORA, 2009 | vs placebo | | | all cause death 0.96 [0.89; 1.04] Cardiovascular death 1.00 [0.87; 1.14] Coronary or peripheral revascularization
0.97 [0.78; 1.20] cardiovascular death, CV events (nonfatal MI, or nonfatal stroke) 0.97 [0.86; 1.09] Noncardiovascular death 0.92 [0.79; 1.08] | | JUPITER (elderly sub group), 2009 | vs placebo | Revascularization 0.51 [0.33; 0.79] stroke 0.55 [0.33; 0.92] Cardiovascular events 0.61 [0.46; 0.81] | | any serious adverse event 1.05 [0.94; 1.18] All cause mortality 0.80 [0.62; 1.04] | | ASTRONOMER, 2010 | vs placebo | | | | | JUPITER (women subgroup) , 2008 | vs placebo | Cv events 0.55 [0.37; 0.81] | | All cause mortality 0.77 [0.55; 1.07] | | HOPE 3, 2016 | 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 |
|---|
| 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: | | 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 | | 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) | | AURORA, 2009 | rosuvastatin 10 mg daily (n=1391) vs. placebo (n=1385) | in patients with end-stage renal disease on hemodialysis | double blind Parallel groups Sample size: 1391/1385 Primary endpoint: cardiovascular death, nonfatal MI, or nonfatal stroke FU duration: 3.2 y mean (max 5.6y) | | JUPITER (elderly sub group), 2009 | rosuvastatin 20mg daily (n=5695) vs. placebo (n=-9) | healthy individuals aged >=70 years with normal LDL cholesterols but with CRP levels >=2.0 mg/dL | double blind Parallel groups Sample size: 5695/-9 Primary endpoint: Cv event FU duration: double-blind | | ASTRONOMER, 2010 | rosuvastatin 40 mg daily (n=134) vs. placebo (n=135) | asymptomatic patients with mild to moderate aortic stenosis and no clinical indications for cholesterol lowering | double blind Parallel groups Sample size: 134/135 Primary endpoint: FU duration: 3.5 y | | JUPITER (women subgroup) , 2008 | Rosuvastatin 20 mg daily (n=3426) vs. placebo (n=3375) | apparently healthy men and women with low-density lipoprotein cholesterol levels of less than 130 mg/dL and high-sensitivity C-reactive protein levels of 2.0 mg/L or higher - subgroup of women | double-blind Parallel groups Sample size: 3426/3375 Primary endpoint: FU duration: 1.9 y | | 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 |
|
| heart failure | All results are NS for efficacy inferior to placebo in terms of death or hospitalization for HF in GISSI-HF rosuvastatine, 2008 (heart failure patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CORONA, 2007 | 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 | vs placebo | | | All cause death 0.77 [0.13; 4.36] | | GISSI-HF rosuvastatine, 2008 | 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) |
|
| venous thrombosis | All results are NS for efficacy inferior to discontinuation in terms of major or clinically
relevant nonmajor bleeding in VanGogh extension, 2007 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| VanGogh extension, 2007 | vs discontinuation | death 0.25 [0.08; 0.79] non fatal PE 0.10 [0.01; 0.73] recurrent VTE 0.27 [0.11; 0.67] | major or clinically
relevant nonmajor bleeding 3.11 [1.48; 6.56] | recurrent DVT only 0.29 [0.08; 1.02] Major bleeding ∞ [NaN; ∞] fatal PE 2.09 [0.19; 23.00] |
| Trial | Treatments | Patients | Method |
|---|
| VanGogh extension, 2007 | once-weekly injections of 2.5 mg of idraparinux for 6 months (n=594) vs. placebo (n=621) | patients who had completed 6 months of prophylaxis with
idraparinux or a vitamin K antagonist and in whom extended anticoagulation was
warranted | Parallel groups Sample size: 594/621 Primary endpoint: FU duration: 6 months |
|
