Table 1.
Study name/first author and year of publication | Type of PCSK9 inhibitor | Treatment in no PCSK9 inhibitor | PCSK9 inhibitor (n) | No PCSK9 inhibitor (n) | Agea (years) | Male (n) | Hypertension (percentage of patients) | Diabetes mellitus (percentage of patients) | Median follow-up duration (weeks) | Baseline statin usage (percentage of patients) |
---|---|---|---|---|---|---|---|---|---|---|
FOURIER/Sabatine et al.8/2017 | Evolocumab 140 mg Q2W; 420 mg Q4W + optimized lipid-lowering regimen | SC placebo Q2W or Q4W + optimized lipid-lowering regimen | 13 784 | 13 780 | 63 ± 9 | 20 795 | 80 | 36 | 114 | 100 |
GLAGOV/Nicholls et al.15/2016 | Evolocumab 420 mg Q4W | SC placebo Q4W | 484 | 484 | 60 ± 9 | 698 | 82 | 21 | 78 | 99 |
ODYSSEY CHOICE 1/Roth et al.16/2016 | Alirocumab 75 mg Q2W; 300 mg Q4W ± statin | SC Placebo Q2W and Q4W ± statin | 573 | 230 | 61 ± 10 | 462 | NR | 27 | 48 | 68 |
ODYSSEY CHOICE 2/Stroes et al.17/2016 | Alirocumab 75 mg Q2W; 150 mg Q4W ± statin | SC placebo Q2W | 175 | 58 | 63 ± 10 | 130 | 61 | 16 | 24 | 0 |
ODYSSEY COMBO 1/Kereiakes et al.14/2015 | Alirocumab 75 mg/150 mg Q2W + Max. tolerated statin + other lipid lowering therapy | SC Placebo Q2W + Max. tolerated statin + other lipid-lowering therapy | 209 | 107 | 63 ± 9 | 208 | NR | 43 | 52 | 100 |
ODYSSEY COMBO 2/Cannon et al.10/2015 | Alirocumab 75 mg Q2W + oral placebo + statin | Ezetimibe + SC placebo Q2W + statin | 479 | 241 | 62 ± 9 | 530 | NR | 31 | 52 | 100 |
ODYSSEY FH 1/Kastelein et al.13/2015 | Alirocumab 75 mg/150 mg Q2W + Max. tolerated lipid lowering therapy | SC placebo Q2W + lipid-lowering therapy | 323 | 163 | 52 ± 13 | 274 | 43 | 12 | 78 | 100 |
ODYSSEY FH 2/Kastelein et al.13/2015 | Alirocumab 75 mg/150 mg Q2W + Max. tolerated lipid lowering therapy | SC placebo Q2W + lipid-lowering therapy | 167 | 82 | 53 ± 13 | 131 | 33 | 4 | 78 | 100 |
ODYSSEY HIGH FH/Ginsberg et al.12/2016 | Alirocumab 150mg Q2W + Max. tolerated lipid-lowering therapy | SC Placebo Q2W + lipid-lowering therapy | 72 | 35 | 51 ± 13 | 57 | 57 | 14 | 78 | 100 |
ODYSSEY LONG TERM/Robinson et al.5/2015 | Alirocumab 150 mg Q2W + statin ± other lipid-lowering therapy | SC Placebo Q2W + statin ± other lipid-lowering therapy | 1553 | 788 | 61 ± 10 | 1457 | NR | 35 | 78 | 100 |
ODYSSEY OPTIONS 1/Bays et al.25/2015 | Alirocumab 75/150 mg Q2W + atorvastatin | Ezetimibe + atorvastatin | 104 | 102 | 63 ± 10 | 231 | 79 | 50 | 32 | 100 |
ODYSSEY OPTIONS 2/Farnier et al.11/2015 | Alirocumab 75 mg/150 mg Q2W + rosuvastatin | Ezetimibe + rosuvastatin + SC placebo Q2W | 103 | 101 | 61 ± 10 | 187 | 71 | 39 | 32 | 79 |
OSLER 1 and OSLER 2/Sabatine et al.9/2015 | Evolocumab 140 mg Q2W; 420 mg Q4W + standard therapy | Standard therapy | 2976 | 1489 | 58 ± 11 | 2255 | 52 | 13 | 48 | 70 |
TESLA/Raal et al.27/2014 | Evolocumab 420 mg Q4W | SC placebo Q4W | 33 | 16 | 31 ± 13 | 25 | 10 | 6 | 12 | 100 |
Yukawa 2/Kiyosue et al.26/2016 | Evolocumab 140 mg Q2W; 420 mg Q4W + atorvastatin therapy | Placebo Q2W; Q4W + atorvastatin | 202 | 202 | 62 ± 11 | 244 | 74 | 49 | 12 | 100 |
Max., maximum; n, number of patients; NR, not reported; PCSK9, proprotein convertase subtilisin/kexin type 9; Q1–Q3, interquartile range; Q2W, every 2 weeks; Q4W, every 4 weeks; SD, standard deviation; SC, subcutaneous.
aValues are mean ± SD; median (Q1–Q3).