Table 1.
Characteristics of the 14 trials identified in the literature search.
| Included studies | Duration (weeks) | Sample size | Female | Mean age, years | Baseline LDL-C, mg/dl | Background therapy | Intervention (experimental group vs control group) | Participants |
|---|---|---|---|---|---|---|---|---|
| BERSON [24] | 12 | 451 | 51.0 | 61 | 89.1 (34.9) | Atorvastatin 20 mg/d | Evolocumab (140 mg Q2 W or 420 mg monthly) + SOC VS SOC | Patients with T2DM and hyperlipidaemia or mixed dyslipidemia |
| FOURIER [25] | 48 | 27564 | 24.6 | 63 | 92.0 (80–109) | Atorvastatin 20 mg daily, with or without ezetimibe | Evolocumab (140 mg Q2 W or 420 mg monthly) VS placebo | Patients with ASCVD and LDL-C>70 mg/dl or higher |
| ODYSSEY OUTCOMES [26] | 48 | 18924 | 25.2 | 59 | 92.0 (31) | High-dose statin therapy or maximum tolerated statin | Alirocumab (75/150 mg Q2 W) VS placebo (Q2 W) | Patients with ACS, and LDL-C>70 mg/dl, non HDL-C> 100 mg/dl, or ApoB >80 mg/dl |
| ODYSSEY COMBO I [27] | 24 | 316 | 32.7 | 63 | 94.8 (29.3) | Stable, maximally tolerated statin dose | Alirocumab (75/150 mg Q2 W) VS placebo (Q2 W) | Patients with high CV risk |
| ODYSSEY COMBO II [28] | 52 | 720 | 27.15 | 62 | 108.2 (34.8) | Stable dose of statin | Alirocumab (75 mg Q2 W) VS ezetimibe (10 mg daily) | Patients with high CV risk |
| ODYSSEY HoFH [29] | 12 | 69 | 49.6 | 43 | 295 (154.6) | Stable dose of statin | Alirocumab (150 mg Q2 W) VS placebo (Q2 W) | Patients with HoFH and LDL-C >70 mg/dl |
| ODYSSEY JAPAN [30] | 24 | 216 | 38.2 | 61 | 142.8 (27.1) | Stable daily statin | Alirocumab (75 mg Q2 W) VS placebo | Patients with heFH, or non-FH at high CV risk |
| ODYSSEY KT [31] | 24 | 199 | 17.5 | 61 | 97.0 (27.8) | Maximally tolerated statin | Alirocumab (75/150 mg Q2 W) VS placebo (Q2 W) | Patients with hypercho- lesterolemia at high CV risk |
| ODYSSEY LONG TERM [32] | 24 | 2341 | 38.3 | 61 | 122.7 (42.6) | High-dose statin therapy or maximum tolerated statin | Alirocumab (150 mg Q2 W) VS placebo | Patients at high risk for CV events |
| ODYSSEY OPTIONS I [33] | 12/24 | 310 | 35.25 | 64 | 109.5 (36.0) | Atorvastatin 20 or 40 mg | Alirocumab (75/150 mg Q2 W) + atorvastatin VS ATV alone/ezetimibe + ATV | Patients with hypercholesterolemia, very-high or high CVD risk |
| ODYSSEY OPTIONS II [34] | 12/24 | 305 | 38.6 | 61 | 113.1 (29.4) | Rosuvastatin 10 or 20 mg | Alirocumab (75/150 mg Q2 W) + RSV VS RSV alone/ezetimibe + RSV | Patients with hypercholesterolemia, very-high or high CVD risk |
| ODYSSEY EAST [35] | 24 | 615 | 25.0 | 59 | 110.8 (48.9) | Maximally tolerated statin therapy | Alirocumab (75/150 mg) VS ezetimibe (10 mg daily) | Patients with hypercholesterolemia, high CV risk |
| YUKAWA-1 [36] | 12 | 219 | 43.5 | 61 | 138.7 (22.1) | Stable statin therapy | Evolocumab (420 mg monthly) + SOC VS SOC | Patients with hypercho-lesterolemic, high CV risk |
| YUKAWA-2 [36] | 12 | 337 | 66.0 | 61 | 106.0 (32.1) | Stable statin therapy | Evolocumab (140 mg Q2 W or 420 mg monthly) + SOC VS SOC | Patients with hypercho-lesterolemic, high CV risk |
CV: cardiovascular; ACS: acute coronary syndrome; HoFH : homozygous familial hypercholesterolemia; heFH: familial hypercholesterolemia; non-FH: nonfamilial hypercholesterolemia; T2DM: type 2 diabetes mellitus; SOC: standard of care; Q2 W: every 2 weeks