pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
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cardiovascular prevention | alirocumab | not classified | versus alirocumab superior to placebo (on top statins) in terms of CHD events in ODYSSEY OUTCOMES, 2018 alirocumab superior to placebo (on top statins) in terms of major CHD event in ODYSSEY OUTCOMES, 2018 alirocumab superior to placebo (on top statins) in terms of cardiovascular events in ODYSSEY OUTCOMES, 2018 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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ODYSSEY OUTCOMES, 2018 | alirocumab vs placebo (on top statins) | CHD events 0.85 [0.78; 0.93] Demonstrated major CHD event 0.88 [0.80; 0.96] Demonstrated cardiovascular events 0.87 [0.81; 0.94] Demonstrated all causes deaths 0.85 [0.73; 0.98] | | cardiovascular death 0.88 [0.74; 1.05] CHD death 0.92 [0.76; 1.11] cardiovascular death 0.88 [0.74; 1.05] |
Trial | Treatments | Patients | Method |
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ODYSSEY OUTCOMES, 2018 | Alirocumab (on top intensive or maximum-tolerated statin therapy) (n=9462) vs. placebo (n=9462) | Post-ACS patients (1 to 12 months)with elevated levels of atherogenic lipoproteins despite intensive or maximum-tolerated statin therapy | double-blind Parallel groups Sample size: 9462/9462 Primary endpoint: FU duration: 2.8 yr (median) |
|
cardiovascular prevention | evolocumab | not classified | versus evolocumab superior to placebo (on top statins) in terms of cardiovascular events in FOURIER, 2017 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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FOURIER, 2017 | evolocumab vs placebo (on top statins) | cardiovascular events 0.80 [0.73; 0.88] Demonstrated stroke (fatal and non fatal) 0.79 [0.66; 0.95] MI ( (fatal and non fatal) 0.73 [0.65; 0.82] | | cardiovascular death 1.05 [0.88; 1.25] all causes deaths 1.04 [0.91; 1.19] cardiovascular death 1.05 [0.88; 1.25] |
Trial | Treatments | Patients | Method |
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FOURIER, 2017 | evolocumab (either 140 mg every 2 weeks or 420 mg monthly) (n=-9) vs. placebo (n=-9) 3 arms | patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 2.2 years |
|
cardiovascular prevention | ezetimibe | not classified | versus placebo or control ezetimibe superior to placebo (on top statins) in terms of CV events (fatal and non fatal) in IMPROVE-IT, 2014 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
IMPROVE-IT, 2014 | ezetimibe vs placebo (on top statins) | CV events (fatal and non fatal) 0.94 [0.89; 0.99] Demonstrated Major coronary event
0.87 [0.80; 0.95] | | all cause death or CV event 0.95 [0.90; 1.00] all cause mortality
0.99 [0.91; 1.07] Death from coronary heart disease 0.96 [0.84; 1.09] Death from cardiovascular causes 1.00 [0.89; 1.13] stroke 0.86 [0.73; 1.01] |
Trial | Treatments | Patients | Method |
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IMPROVE-IT, 2014 | 10 mg/day of ezetimibe and 40 mg/day of simvastatin (n=9067) vs. simvastatin 40 mg/day (n=9077) If LDL-C response is inadequate, the dose of simvastatin may be increased to 80 mg | subjects with stabilized high-risk acute coronary syndrome | double blind Parallel groups Sample size: 9067/9077 Primary endpoint: CV death, MI, hospitalization for unstable angina, stroke and coronary revascularization FU duration: 5.68 years |
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