Table 2.
Efficacy results at week 12 and at the mean of weeks 10 and 12
| Variable | Week 12 | Mean of weeks 10 and 12 | ||
|---|---|---|---|---|
| Placebo (n = 141) |
Evolocumab (n = 280) |
Placebo (n = 141) |
Evolocumab (n = 280) |
|
| LDL-C | ||||
| Change from baseline, %, mean (SEM)a | −1.1 (1.9) | −54.3 (1.4) | −0.8 (1.8) | −65.0 (1.3) |
| Treatment difference, mean (SEM)b | −53.1 (2.3)† | −64.1 (2.1)† | ||
| Achievement of <1.81 mmol/l, n (%) | 20 (15.4) | 213 (84.5) | 20 (14.8) | 253 (92.7) |
| Achievement of ≥50% reduction, n (%) | 1 (0.8) | 165 (65.5) | 1 (0.7) | 221 (84.2) |
| Change from baseline in other lipids, %, mean (SEM)a | ||||
| Non-HDL-C | −0.6 (1.8) | −46.9 (1.3) | −0.1 (1.6) | −56.6 (1.2) |
| ApoB | 1.8 (1.7) | −40.3 (1.3) | 2.3 (1.6) | −50.2 (1.2) |
| Total cholesterol | −1.2 (1.4) | −35.0 (1.0) | −1.1 (1.2) | −42.2 (0.9) |
| Lp(a) | 7.4 (3.1) | −25.2 (2.3) | 9.6 (3.3) | −30.9 (2.4) |
| Triacylglycerol | 4.8 (3.4) | −8.9 (2.5) | 6.6 (2.9) | −12.6 (2.2) |
| HDL-C | −1.4 (1.4) | 6.0 (1.0) | −2.6 (1.3) | 7.2 (0.9) |
| VLDL-C | 3.0 (2.9) | −10.3 (2.2) | 3.4 (2.6) | −13.6 (1.9) |
| Change from baseline in glycaemic measure, median (Q1, Q3) | ||||
| HbA1c, % | 0.1 (−0.2, 0.5) | 0.1 (−0.2, 0.5)‡ | N/A | N/A |
| HbA1c, mmol/mol | 1.1 (−2.2, 5.5) | 1.1 (−2.2, 5.5) | ||
| Fasting serum glucose, mmol/l | 0.2 (−0.8, 1.6) | 0.3 (−0.8, 1.7)§ | N/A | N/A |
aLeast-squares mean is from the repeated-measures model, which includes treatment group, stratification factor (from interactive voice response system), scheduled visit and the interaction of treatment with scheduled visit as covariates
bTreatment differences use s.c. placebo as the reference
†p<0.0001; ‡p=0.939; and §p=0.785 all vs placebo
N/A, not applicable (not measured)