| Trial | control | p<0.05 | harm | NS |
|---|
| ODYSSEY Long-Term, 2015 | alirocumab vs placebo (on top statins) | myocardial infarction as adverse event 0.39 [0.20; 0.79] | death from all causes as adverse event 0.29 [0.09; 0.99] | General allergic reaction 1.06 [0.81; 1.37] serious adverse events 0.96 [0.80; 1.14] cardiovascular events as adverse events 0.91 [0.63; 1.33] Neurocognitive disorder 2.28 [0.78; 6.72] neurological SAE 0.94 [0.63; 1.41] cardiovascular death as adverse event 0.41 [0.16; 1.02] |
| ODYSSEY Alternative | alirocumab vs placebo (on top statins) | | | serious adverse events 1.19 [0.53; 2.65] death from all causes as adverse event NaN [NaN; NaN] myocardial infarction as adverse event ∞ [NaN; ∞] cardiovascular death as adverse event NaN [NaN; NaN] |
| 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] |
| ODYSSEY MONO | alirocumab vs ezetimibe alone | | | serious adverse events 0.98 [0.06; 15.26] death from all causes as adverse event NaN [NaN; NaN] cardiovascular death as adverse event NaN [NaN; NaN] |
| ODYSSEY FH 1 | alirocumab vs placebo (on top statins) | | | |
| ODYSSEY FH 2 | alirocumab vs placebo (on top statins) | | | |
| ODYSSEY HIGH FH | alirocumab vs placebo (on top statins) | | | serious adverse events 0.97 [0.31; 3.01] death from all causes as adverse event NaN [NaN; NaN] cardiovascular death as adverse event NaN [NaN; NaN] |
| ODYSSEY OPTIONS I | alirocumab vs ezetimibe (on top statin) | | | serious adverse events 0.56 [0.17; 1.86] death from all causes as adverse event 0.00 [0.00; NaN] cardiovascular death as adverse event 0.00 [0.00; NaN] |
| ODYSSEY OPTIONS II | alirocumab vs ezetimibe (on top statin) | | | serious adverse events 0.74 [0.26; 2.04] death from all causes as adverse event 0.00 [0.00; NaN] cardiovascular death as adverse event 0.00 [0.00; NaN] |
| ODYSSEY COMBO | alirocumab vs placebo (on top statins) | | | serious adverse events 0.95 [0.52; 1.74] death from all causes as adverse event 0.51 [0.03; 8.11] myocardial infarction as adverse event 0.51 [0.03; 8.11] cardiovascular death as adverse event 0.34 [0.06; 2.01] |
| ODYSSEY COMBO II | alirocumab vs placebo (on top statins) | | | serious adverse events 1.05 [0.76; 1.46] death from all causes as adverse event 0.50 [0.07; 3.55] cardiovascular death as adverse event 0.25 [0.05; 1.36] |
| Trial | Treatments | Patients | Method |
|---|
| ODYSSEY Long-Term, 2015 | alirocumab 150 mg as a 1-ml subcutaneous injection every 2 weeks for 78 weeks. (n=1553) vs. placebo (n=788) | patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or more and were receiving treatment with statins at the maximum tolerated dose (the highest dose associated with an acceptable side-effect profile), with or without other lipid-lowering therapy | Sample size: 1553/788 Primary endpoint: change in LDL at week 24 FU duration: 78 wk |
| ODYSSEY Alternative | Alirocumab 75 mg with potential up-titration to 150 mg Q2W (n=-9) vs. Ezetimibe 10 mg (n=-9) | statin-intolerant patients | double-blind Sample size: -9/-9 Primary endpoint: percent change in LDL-C from baseline to week 24 FU duration: 24 wk |
| 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) |
| ODYSSEY MONO | Alirocumab 75 mg Q2W (n=-9) vs. Ezetimibe 10 mg (n=-9) | hypercholesterolemic patients at moderate cardiovascular risk not receiving statins or other lipid-lowering therapy | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 24 wk |
| ODYSSEY FH 1 | Alirocumab 75 mg with potential up-titration to 150 mg Q2W (n=-9) vs. Placebo (n=-9) | patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 78 wk |
| ODYSSEY FH 2 | Alirocumab 75 mg with potential up-titration to 150 mg Q2W (n=-9) vs. Placebo (n=-9) | patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy | double blind Sample size: -9/-9 Primary endpoint: FU duration: 78 wk |
| ODYSSEY HIGH FH | Alirocumab 150 mg Q2W (n=-9) vs. Placebo (n=-9) | patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy | Sample size: -9/-9 Primary endpoint: FU duration: 52–78 wk |
| ODYSSEY OPTIONS I | Alirocumab 75 mg with potential up-titration to 150 mg Q2W (n=-9) vs. Ezetimibe 10 mg (n=-9) | high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg) | Sample size: -9/-9 Primary endpoint: FU duration: 24 wk |
| ODYSSEY OPTIONS II | Alirocumab 75 mg with potential up-titration to 150 mg Q2W (n=-9) vs. Ezetimibe 10 mg (n=-9) | high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg) | Sample size: -9/-9 Primary endpoint: FU duration: 24 wk |
| ODYSSEY COMBO | Alirocumab 75 mg with potential up-titration to 150 mg Q2W (n=-9) vs. Placebo (n=-9) | high cardiovascular risk patients on maximally tolerated statin therapy | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 52 wk |
| ODYSSEY COMBO II | Alirocumab 75 mg with potential up-titration to 150 mg Q2W (n=-9) vs. Ezetimibe 10 mg (n=-9) | high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 104 wk |
