| cardiovascular prevention | versus evolocumab superior to placebo (on top statins) in terms of cardiovascular events in FOURIER, 2017 evolocumab inferior to ezetimibe alone in terms of Muscle-related adverse events in GAUSS 2 | 11 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
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| MENDEl 2 | evolocumab vs | | | | | DESCARTES, 2014 | evolocumab vs placebo (on top statins) | | | serious adverse events 1.28 [0.68; 2.40] death from all causes as adverse event ∞ [NaN; ∞] cardiovascular events as adverse events 1.51 [0.31; 7.45] | | Mendel 1, 2012 | evolocumab vs | | | | | LAPLACE-TIMI 57 | evolocumab vs placebo (on top statins) | | | | | GAUSS 1, 2012 | evolocumab vs placebo | | | serious adverse events ∞ [NaN; ∞] death from all causes as adverse event NaN [NaN; NaN] Muscle-related adverse events 0.81 [0.31; 2.12] | | RUTHERFORD-1 | evolocumab vs placebo (on top statins) | | | serious adverse events ∞ [NaN; ∞] death from all causes as adverse event NaN [NaN; NaN] | | YUKAWA-1, 2014 | evolocumab vs | | | | | LAPLACE 2, 2014 | evolocumab vs placebo (on top statins) | | | serious adverse events 0.88 [0.45; 1.73] death from all causes as adverse event 0.00 [0.00; NaN] cardiovascular events as adverse events 1.25 [0.24; 6.42] Neurocognitive disorder ∞ [NaN; ∞] | | GAUSS 2 | evolocumab vs ezetimibe alone | | Muscle-related adverse events 1.85 [1.11; 3.09] | serious adverse events 3.01 [0.87; 10.45] death from all causes as adverse event NaN [NaN; NaN] | | RUTHERFORD-2, 2015 | evolocumab vs placebo (on top statins) | | | serious adverse events 0.69 [0.23; 2.14] death from all causes as adverse event NaN [NaN; NaN] cardiovascular events as adverse events ∞ [NaN; ∞] Muscle-related adverse events 4.95 [0.64; 38.21] Neurocognitive disorder NaN [NaN; NaN] | | 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 |
|---|
| MENDEl 2 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | | DESCARTES, 2014 | evolocumab (420 mg) every 4 weeks (n=599) vs. placebo (n=302) | | Sample size: 599/302 Primary endpoint: FU duration: 52 weeks | | Mendel 1, 2012 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | | LAPLACE-TIMI 57 | subcutaneous injections of AMG 145 70 mg, 105 mg, or 140 mg, (n=-9) vs. placebo (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | | GAUSS 1, 2012 | (n=95) vs. (n=32) placebo- and ezetimibe-controlled | statin-intolerant patients | Sample size: 95/32 Primary endpoint: FU duration: | | RUTHERFORD-1 | AMG 145 350 mg, AMG 145 420 mg (n=111) vs. placebo (n=56) | heterozygous familial hypercholesterolemia patients | Sample size: 111/56 Primary endpoint: FU duration: | | YUKAWA-1, 2014 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | | LAPLACE 2, 2014 | evolucumab + statin (n=1117) vs. placebo + statin (n=558) | | Sample size: 1117/558 Primary endpoint: FU duration: | | GAUSS 2 | evolocumab 140 mg every two weeks (Q2W) or evolocumab 420 mg once monthly (QM) (n=102) vs. ezetimibe 10 mg (n=205) | patients with statin intolerance | Sample size: 102/205 Primary endpoint: FU duration: | | RUTHERFORD-2, 2015 | subcutaneous evolocumab 140 mg every 2 weeks, evolocumab 420 mg monthly (n=220) vs. placebo (n=109) | heterozygous familial hypercholesterolaemia | Sample size: 220/109 Primary endpoint: FU duration: | | 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 |
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