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Table 2 Primary and key secondary endpoints in COMBO I and II

From: Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials

Primary endpoint Population
Percentage change in calculated LDL-C from baseline to week 24 in the ITT population, using all LDL-C values regardless of adherence to treatment (ITT analysis) ITT
Key secondary endpoints Population
Percentage change in calculated LDL-C from baseline to week 24 in the modified ITT population, using all LDL-C values during the efficacy treatment period (on-treatment analysis) mITT
Percentage change in calculated LDL-C from baseline to week 12 (ITT analysis) ITT
Percentage change in calculated LDL-C from baseline to week 12 (on-treatment analysis) mITT
Percentage change in Apo B from baseline to week 24 (ITT analysis) ITT
Percentage change in Apo B from baseline to week 24 (on-treatment analysis) mITT
Percentage change in non-HDL-C from baseline to week 24 (ITT analysis) ITT
Percentage change in non-HDL-C from baseline to week 24 (on-treatment analysis) mITT
Percentage change in total cholesterol from baseline to week 24 (ITT analysis) ITT
Percentage change in Apo B from baseline to week 12 (ITT analysis) ITT
Percentage change in non-HDL-C from baseline to week 12 (ITT analysis) ITT
Percentage change in total cholesterol from baseline to week 12 (ITT analysis) ITT
Percentage change in calculated LDL-C from baseline to week 52 (ITT analysis) ITT
Proportion of patients reaching calculated LDL-C <70 mg/dL (1.81 mmol/L) at week 24 (ITT analysis) ITT
Proportion of patients reaching calculated LDL-C <70 mg/dL (1.81 mmol/L) at week 24 (on-treatment analysis) mITT
Percentage change in Lp(a) from baseline to week 24 (ITT analysis) ITT
Percentage change in HDL-C from baseline to week 24 (ITT analysis) ITT
Percentage change in fasting TGs from baseline to week 24 (ITT analysis) ITT
Percentage change in Apo A1 from baseline to week 24 (ITT analysis) ITT
Percentage change in Lp(a) from baseline to week 12 (ITT analysis) ITT
Percentage change in HDL-C from baseline to week 12 (ITT analysis) ITT
Percentage change in fasting TGs from baseline to week 12 (ITT analysis) ITT
Percentage change in Apo A1 from baseline to week 12 (ITT analysis) ITT
  1. 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; TGs, triglycerides.