Skip to main content

Table 1 Key secondary efficacy endpoints (in hierarchical order)

From: Efficacy and safety of alirocumab in patients with hypercholesterolemia not adequately controlled with non-statin lipid-lowering therapy or the lowest strength of statin: ODYSSEY NIPPON study design and rationale

1. The percentage changes in calculated LDL-C from baseline to week 12 in the mITT population, using all LDL-C values during the efficacy double-blind treatment period (on-treatment estimand).

2. The percentage change in calculated LDL-C from baseline to average week 10–12 (ITT estimand).

3. The percentage change in calculated LDL-C from baseline to average week 10–12 (on-treatment estimand).

4. The percentage change in Apo-B from baseline to week 12 (ITT estimand).

5. The percentage change in Apo-B from baseline to week 12 (on-treatment estimand).

6. The percentage change in non-HDL-C from baseline to week 12 (ITT estimand).

7. The percentage change in non-HDL-C from baseline to week 12 (on-treatment estimand).

8. The percentage change in TC from baseline to week 12 (ITT estimand).

9. The proportion of patients reaching LDL-C goal at week 12, i.e. calculated LDL-C < 100 mg/dL (2.6 mmol/L) for heFH or non-FH patients who have a history of documented CHD patients, or LDL-C < 120 mg/dL (3.1 mmol/L) for non-FH patients who have a history of documented diseases or other risk factors classified as primary prevention category III (ITT estimand).

10. The proportion of patients reaching LDL-C goal at week 12, i.e. calculated LDL-C < 100 mg/dL (2.6 mmol/L) for heFH or non-FH patients who have a history of documented CHD patients, or LDL-C < 120 mg/dL (3.1 mmol/L) for non-FH patients who have a history of documented diseases or other risk factors classified as primary prevention category III (on-treatment estimand).

11. The percentage change in lipoprotein(a) from baseline to week 12 (ITT estimand).

12. The percentage change in HDL-C from baseline to week 12 (ITT estimand).

13. The percentage change in fasting triglyceride from baseline to week 12 (ITT estimand).

14. The percentage change in Apo A-1 from baseline to week 12 (ITT estimand).

  1. Apo apolipoprotein, CHD coronary heart disease, FH familial hypercholesterolemia, HDL-C high-density lipoprotein cholesterol, heFH heterozygous familial hypercholesterolemia, ITT intent-to-treat, LDL-C low-density lipoprotein cholesterol, mITT modified intent-to-treat, TC total cholesterol
Back to article page

Lipids in Health and Disease

ISSN: 1476-511X