Table 4.
Selected phase III clinical trials evaluating alirocumab and evolocumab
| Author, trial name (reference) | Year | n | Agent | Population and study design | FU (w) | Percentage change vs. placebo group | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| LDL-C | ApoB | Non-HDL-C | TG | HDL-C | Lp(a) | ||||||
| Farnier et al., ODYSSEY MONO [65] | 2014 | 103 | Alirocumab | Patients with hypercholesterolemia on no statins vs. ezetimibe | 24 | −31.6 | −25.8 | −25.5 | −1.2 | 4.4 | −4.4 |
| Kereiakes et al., ODYSSEY COMBO I [66] | 2015 | 311 | Alirocumab | Patients with hypercholesterolemia not adequately controlled and high CVD risk | 24 | −45.9 | −35.8 | −37.5 | −0.6 | 7.3 | −14.6 |
| Colhoun et al., ODYSSEY COMBO II [67] | 2015 | 707 | Alirocumab | Patients with hypercholesterolemia not adequately controlled and high CVD risk | 24 | −29.7 | −22.4 | −22.9 | −0.3 | 8.1 | −21.7 |
| Robinson et al., ODYSSEY LONG TERM [73] | 2015 | 2341 | Alirocumab | Patients with hypercholesterolemia not adequately controlled and high CVD risk | 24 | −61.9 | −54.0 | −52.3 | −17.3 | 4.6 | −25.6 |
| Blom et al., DESCARTES [53] | 2014 | 901 | Evolocumab | Patients with hyperlipidaemia had four-weekly 420 mg evolocumab in addition to diet alone, diet and atorvastatin or to diet plus atorvastatin plus ezetimibe | 52 | −57.0 | −44.2 | −50.3 | −11.5 | 5.4 | −22.4 |
| Robinson et al., LAPLACE-2 [52] | 2014 | 2067 | Evolocumab | Patients with hyperlipidaemia had either 140 mg fortnightly or 420 mg every 4 weeks evolocumab added to statin therapy compared with ezetimibe | 12 | −59.2 to −70.6 | −47.0 | −54.9 | −9.3 to −31.4 | 3.2 to 9.8 | −19.8 to −36.5 |
| Stroes et al., GAUSS-2 [62] | 2014 | 307 | Evolocumab | Patients with statin intolerance given 140 mg fortnightly or 420 mg every 4 weeks evolocumab and were compared to those on ezetimibe | 12 | −68.8 to −69.7 | −32.9 | NR | NR | 3.6 to 4.8 | −25.3 to −27.9 |
| Koren et al., MENDEL-2 [49] | 2014 | 614 | Evolocumab | Patients with hypercholesterolemia on no statins 140 mg fortnightly or 420 mg every 4 weeks evolocumab and were compared to those on ezetimibe | 12 | −54.8 to −57.1 | −47.8 | −49.8 to −51.2 | −6.2 to −17.7 | 5.9 to 9.3 | −17.8 to −20.4 |
| Raal et al., RUTHERFORD-2 [55] | 2015 | 329 | Evolocumab | Patients with heterozygous FH given 140 mg fortnightly or 420 mg every 4 weeks | 12 | −59.2 to −61.3 | −49.1 | −54.8 to −55.0 | −11.6 to −19.6 | 9.1 to 9.2 | −28.2 to −31.6 |
| Sabatine et al., OSLER-2 [79] | 2015 | 4465 | Evolocumab | Hypercholesterolemia or mixed dyslipidaemia who had participated in the previous OSLER study | 12 | −61.0 | −47.3 | −52.0 | −12.6 | 7.0 | −25.5 |
| Raal et al., TESLA Part B [57] | 2015 | 49 | Evolocumab | Patients with homozygous FH not on apheresis were given 420 mg every 4 weeks of evolocumab | 12 | −30.9 | −23.1 | NR | 0.3 | −0.1 | −11.8 |
Values in table represent percentage (%) change in lipid parameters.
ApoB apolipoprotein B, FU follow-up, HDL-C high-density lipoprotein cholesterol, HeFH heterozygous familial hypercholesterolaemia, LDL-C low-density lipoprotein cholesterol, Lp(a) lipoprotein (a), mg milligram, n number, NA not available, TG triglycerides
See main text for full explanation of trial abbreviations