Table 2.
Key Study Endpoints (Common to Both Studies)
| Primary endpoint |
| Difference in % change in calculated LDL‐C from baseline to week 24 in the alirocumab vs the control arms in the ITT population, using all LDL‐C values regardless of adherence to treatment (ITT estimand) |
| Key secondary endpoints (unless otherwise noted, all are the difference in % change in lipid parameter in the alirocumab vs control arms): |
| Calculated LDL‐C from baseline to week 24 in the mITT population, using all LDL‐C values during the efficacy treatment period (on‐treatment estimand) |
| Calculated LDL‐C from baseline to week 12 (ITT estimand) |
| Calculated LDL‐C from baseline to week 12 (on‐treatment estimand) |
| Apo B from baseline to week 24 (ITT estimand) |
| Apo B from baseline to week 24 (on‐treatment estimand) |
| Non–HDL‐C from baseline to week 24 (ITT estimand) |
| Non–HDL‐C from baseline to week 24 (on‐treatment estimand) |
| Total cholesterol from baseline to week 24 (ITT estimand) |
| Apo B from baseline to week 12 (ITT estimand) |
| Non–HDL‐C from baseline to week 12 (ITT estimand) |
| Total cholesterol from baseline to week 12 (ITT estimand) |
| Calculated LDL‐C from baseline to week 52 (ITT estimand) |
| Proportion of very high‐CV‐risk patients reaching calculated LDL‐C <70 mg/dL (1.81 mmol/L) or high‐CV‐risk patients reaching calculated LDL‐C <100 mg/dL (2.59 mmol/L) at week 24 (ITT estimand) |
| Proportion of very high‐CV‐risk patients reaching calculated LDL‐C <70 mg/dL (1.81 mmol/L) or high‐CV‐risk patients reaching calculated LDL‐C <100 mg/dL (2.59 mmol/L) at week 24 (on‐treatment estimand) |
| Proportion of patients reaching LDL‐C <70 mg/dL (1.81 mmol/L) at week 24 (ITT estimand) |
| Proportion of patients reaching LDL‐C <70 mg/dL (1.81 mmol/L) at week 24 (on‐treatment estimand) |
| Lp(a) from baseline to week 24 (ITT estimand) |
| HDL‐C from baseline to week 24 (ITT estimand) |
| Fasting TG from baseline to week 24 (ITT estimand) |
| Apo A‐1 from baseline to week 24 (ITT estimand) |
| Lp(a) from baseline to week 12 (ITT estimand) |
| HDL‐C from baseline to week 12 (ITT estimand) |
| Fasting TG from baseline to week 12 (ITT estimand) |
| Apo A‐1 from baseline to week 12 (ITT estimand) |
Abbreviations: Apo, apolipoprotein; HDL‐C, high‐density lipoprotein cholesterol; ITT, intent‐to‐treat; LDL‐C, low‐density lipoprotein cholesterol; Lp(a), lipoprotein(a); mITT, modified intent‐to‐treat; TG, triglycerides.