Hypercholesterolemia
Conditions
Brief summary
Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: * To evaluate the long-term efficacy of alirocumab on lipid parameters. * To evaluate the long-term immunogenicity of alirocumab.
Detailed description
The maximum study duration will be 176 weeks per participant.
Interventions
DRUGAlirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).
Exclusion criteria
Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Adverse Events (AEs) | Up to 10 weeks after last study drug administration (maximum of 176 weeks) | Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Parent Baseline, Weeks 48, 96, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Parent Baseline, Weeks 48, 96, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Parent Baseline, Weeks 48, 96, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Parent Baseline, Weeks 48, 96, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
| Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 | Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study. |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Portugal, Romania, Russia, South Africa, Spain, Sweden, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 177 centers in 24 countries. Overall, 986 participants who completed study EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831) were enrolled between December 2013 and December 2014.
Pre-assignment details
The Day 1 visit of this study was: the end of treatment visit of the 78-week treatment period for participants who completed EFC12492, R727-CL-1112 and EFC12732; and the end of study visit i.e. 8 weeks after completion of the 78-week treatment period for participants who completed LTS11717.
Participants by arm
| Arm | Count |
|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. | 330 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. | 655 |
| Total | 985 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 23 |
| Overall Study | Enrolled but not treated | 1 | 0 |
| Overall Study | Other than specified above | 10 | 21 |
| Overall Study | Participant Moved | 0 | 4 |
| Overall Study | Poor compliance to protocol | 7 | 7 |
| Overall Study | Related to Study Drug administration | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo to Alirocumab 75 or 150 mg Q2W | Alirocumab to Alirocumab 75 or 150 mg Q2W |
|---|---|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 11.9 | 54.8 years STANDARD_DEVIATION 11.4 | 54.1 years STANDARD_DEVIATION 12.1 |
| Calculated LDL-C in mg/dL | 152.0 mg/dL STANDARD_DEVIATION 53.2 | 148.8 mg/dL STANDARD_DEVIATION 48.8 | 153.5 mg/dL STANDARD_DEVIATION 55.3 |
| Calculated LDL-C in mmol/L | 3.936 mmol/L STANDARD_DEVIATION 1.379 | 3.854 mmol/L STANDARD_DEVIATION 1.265 | 3.977 mmol/L STANDARD_DEVIATION 1.432 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 12 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 940 Participants | 317 Participants | 623 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American/Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 938 Participants | 310 Participants | 628 Participants |
| Race/Ethnicity, Customized White/American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Asian | 7 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White/Black or African American | 11 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Female | 435 Participants | 148 Participants | 287 Participants |
| Sex: Female, Male Male | 550 Participants | 182 Participants | 368 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 330 | 7 / 655 | 11 / 985 |
| other Total, other adverse events | 183 / 330 | 366 / 655 | 549 / 985 |
| serious Total, serious adverse events | 68 / 330 | 144 / 655 | 212 / 985 |
Outcome results
Primary
Percentage of Participants Who Experienced Adverse Events (AEs)
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.
Time frame: Up to 10 weeks after last study drug administration (maximum of 176 weeks)
Population: All enrolled participants who received at least one dose or part of a dose of alirocumab in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Who Experienced Adverse Events (AEs) | Any Serious AE | 20.6 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Who Experienced Adverse Events (AEs) | Any AE | 83.9 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Who Experienced Adverse Events (AEs) | Any AE leading to treatment discontinuation | 3.0 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Who Experienced Adverse Events (AEs) | Any Serious AE | 22.0 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Who Experienced Adverse Events (AEs) | Any AE | 87.3 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Who Experienced Adverse Events (AEs) | Any AE leading to treatment discontinuation | 3.5 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Who Experienced Adverse Events (AEs) | Any AE | 86.2 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Who Experienced Adverse Events (AEs) | Any AE leading to treatment discontinuation | 3.4 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Who Experienced Adverse Events (AEs) | Any Serious AE | 21.5 percentage of participants |
Secondary
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 48, 96, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 48 | -0.340 ratio | Standard Deviation 0.245 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 96 | -0.340 ratio | Standard Deviation 0.228 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 144 | -0.342 ratio | Standard Deviation 0.242 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 168 | -0.370 ratio | Standard Deviation 0.161 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 168 | -0.498 ratio | Standard Deviation 0.28 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 48 | -0.361 ratio | Standard Deviation 0.304 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 144 | -0.414 ratio | Standard Deviation 0.433 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 96 | -0.375 ratio | Standard Deviation 0.268 |
| Alirocumab: All Participants | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 168 | -0.447 ratio | Standard Deviation 0.238 |
| Alirocumab: All Participants | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 96 | -0.363 ratio | Standard Deviation 0.256 |
| Alirocumab: All Participants | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 144 | -0.389 ratio | Standard Deviation 0.379 |
| Alirocumab: All Participants | Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 | Week 48 | -0.354 ratio | Standard Deviation 0.286 |
Secondary
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -66.8 mg/dL | Standard Deviation 45.6 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -70.3 mg/dL | Standard Deviation 49.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -71.2 mg/dL | Standard Deviation 44.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -70.2 mg/dL | Standard Deviation 45.9 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -72.3 mg/dL | Standard Deviation 45.6 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -67.8 mg/dL | Standard Deviation 49.7 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -73.1 mg/dL | Standard Deviation 50 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -66.1 mg/dL | Standard Deviation 24.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -75.9 mg/dL | Standard Deviation 55 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -67.1 mg/dL | Standard Deviation 49.2 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -75.2 mg/dL | Standard Deviation 59.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -86.2 mg/dL | Standard Deviation 57.8 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -72.7 mg/dL | Standard Deviation 52.4 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -73.9 mg/dL | Standard Deviation 54.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -99.4 mg/dL | Standard Deviation 48.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -74.9 mg/dL | Standard Deviation 54.5 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -71.9 mg/dL | Standard Deviation 52.8 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -74.0 mg/dL | Standard Deviation 52.2 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -81.6 mg/dL | Standard Deviation 55.4 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -86.1 mg/dL | Standard Deviation 42.4 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -73.7 mg/dL | Standard Deviation 51.4 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -67.0 mg/dL | Standard Deviation 48 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -74.2 mg/dL | Standard Deviation 55.2 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -71.9 mg/dL | Standard Deviation 51.4 |
Secondary
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -1.843 mmol/L | Standard Deviation 1.154 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -1.821 mmol/L | Standard Deviation 1.282 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -1.818 mmol/L | Standard Deviation 1.19 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -1.874 mmol/L | Standard Deviation 1.18 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -1.894 mmol/L | Standard Deviation 1.294 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -1.712 mmol/L | Standard Deviation 0.641 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -1.729 mmol/L | Standard Deviation 1.18 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -1.757 mmol/L | Standard Deviation 1.286 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -1.965 mmol/L | Standard Deviation 1.426 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -1.949 mmol/L | Standard Deviation 1.546 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -1.738 mmol/L | Standard Deviation 1.273 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -2.232 mmol/L | Standard Deviation 1.498 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -1.914 mmol/L | Standard Deviation 1.405 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -2.574 mmol/L | Standard Deviation 1.252 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -1.883 mmol/L | Standard Deviation 1.356 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -1.940 mmol/L | Standard Deviation 1.411 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -1.908 mmol/L | Standard Deviation 1.332 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -1.863 mmol/L | Standard Deviation 1.332 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -1.735 mmol/L | Standard Deviation 1.242 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -1.923 mmol/L | Standard Deviation 1.428 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -2.229 mmol/L | Standard Deviation 1.098 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -1.861 mmol/L | Standard Deviation 1.368 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -2.114 mmol/L | Standard Deviation 1.436 |
| Alirocumab: All Participants | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -1.916 mmol/L | Standard Deviation 1.353 |
Secondary
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 24 | 77.0 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 168 | 75.0 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 48 | 77.7 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 144 | 72.5 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 8 | 71.0 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 72 | 82.9 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 96 | 79.2 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Baseline | 12.1 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 120 | 78.2 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 8 | 86.1 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 120 | 76.7 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Baseline | 11.5 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 144 | 74.4 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 168 | 83.3 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 24 | 75.7 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 72 | 77.6 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 48 | 76.4 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 96 | 76.8 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 168 | 80.0 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 72 | 79.4 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Baseline | 11.7 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 8 | 81.1 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 24 | 76.1 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 48 | 76.8 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 96 | 77.6 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 120 | 77.2 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time | Week 144 | 73.7 percentage of participants |
Secondary
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 120 | 52.7 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 144 | 46.4 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 24 | 53.4 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 168 | 50.0 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Baseline | 0.9 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 48 | 51.1 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 8 | 47.4 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 72 | 57.0 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 96 | 53.0 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 96 | 56.4 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 120 | 50.9 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Baseline | 1.2 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 72 | 53.2 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 144 | 48.1 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 48 | 53.5 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 8 | 66.4 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 168 | 33.3 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 24 | 53.1 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 168 | 40.0 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Baseline | 1.1 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 8 | 60.1 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 24 | 53.2 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 48 | 52.7 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 72 | 54.5 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 120 | 51.5 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 144 | 47.5 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time | Week 96 | 55.3 percentage of participants |
Secondary
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 48 | 52.1 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 168 | 50.0 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 96 | 53.0 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 72 | 57.3 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Baseline | 0.9 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 144 | 46.4 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 24 | 54.1 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 8 | 49.5 percentage of participants |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 120 | 53.2 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 72 | 54.4 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Baseline | 1.2 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 8 | 67.1 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 24 | 54.3 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 48 | 54.5 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 96 | 57.7 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 120 | 53.1 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 144 | 48.8 percentage of participants |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 168 | 33.3 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 24 | 54.2 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Baseline | 1.1 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 120 | 53.1 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 8 | 61.3 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 168 | 40.0 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 72 | 55.4 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 48 | 53.7 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 144 | 48.0 percentage of participants |
| Alirocumab: All Participants | Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time | Week 96 | 56.1 percentage of participants |
Secondary
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 48, 96, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 96 | 7.8 percent change | Standard Deviation 15.4 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 168 | 0.9 percent change | Standard Deviation 19.3 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 144 | 11.2 percent change | Standard Deviation 16.3 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 48 | 5.6 percent change | Standard Deviation 14.5 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 96 | 8.5 percent change | Standard Deviation 14.1 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 48 | 5.8 percent change | Standard Deviation 17.2 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 168 | 3.9 percent change | Standard Deviation 9.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 144 | 10.2 percent change | Standard Deviation 18.7 |
| Alirocumab: All Participants | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 168 | 2.7 percent change | Standard Deviation 13.2 |
| Alirocumab: All Participants | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 144 | 10.6 percent change | Standard Deviation 17.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 48 | 5.7 percent change | Standard Deviation 16.3 |
| Alirocumab: All Participants | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 | Week 96 | 8.3 percent change | Standard Deviation 14.5 |
Secondary
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 48, 96, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 48 | -36.9 percent change | Standard Deviation 21.7 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 96 | -36.9 percent change | Standard Deviation 20.9 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 144 | -33.9 percent change | Standard Deviation 20.9 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 168 | -38.0 percent change | Standard Deviation 9 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 168 | -43.1 percent change | Standard Deviation 20.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 48 | -37.8 percent change | Standard Deviation 23.4 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 144 | -36.9 percent change | Standard Deviation 21.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 96 | -38.0 percent change | Standard Deviation 22.9 |
| Alirocumab: All Participants | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 168 | -41.1 percent change | Standard Deviation 16.5 |
| Alirocumab: All Participants | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 96 | -37.6 percent change | Standard Deviation 22.3 |
| Alirocumab: All Participants | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 144 | -35.9 percent change | Standard Deviation 21.2 |
| Alirocumab: All Participants | Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 | Week 48 | -37.5 percent change | Standard Deviation 22.9 |
Secondary
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: Modified ITT (mITT) population: all enrolled and treated participants with 1 baseline (from parent study) and at least 1 post-baseline calculated LDL-C value on-treatment. Number analyzed = participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -46.5 percent change | Standard Deviation 25.8 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -45.6 percent change | Standard Deviation 28 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -44.9 percent change | Standard Deviation 25.9 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -43.6 percent change | Standard Deviation 13.4 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -47.4 percent change | Standard Deviation 23.8 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -47.4 percent change | Standard Deviation 24 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -47.7 percent change | Standard Deviation 23.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -46.9 percent change | Standard Deviation 27.5 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -47.5 percent change | Standard Deviation 28.8 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -47.3 percent change | Standard Deviation 28.4 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -46.6 percent change | Standard Deviation 31.1 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -49.6 percent change | Standard Deviation 24.6 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -52.2 percent change | Standard Deviation 20.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -43.8 percent change | Standard Deviation 28.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -46.9 percent change | Standard Deviation 29.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -48.2 percent change | Standard Deviation 28.2 |
| Alirocumab: All Participants | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -44.2 percent change | Standard Deviation 27.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -46.8 percent change | Standard Deviation 28.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -47.9 percent change | Standard Deviation 26.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -46.9 percent change | Standard Deviation 28.7 |
| Alirocumab: All Participants | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -47.4 percent change | Standard Deviation 26.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -48.8 percent change | Standard Deviation 17.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -48.5 percent change | Standard Deviation 25 |
| Alirocumab: All Participants | Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -46.9 percent change | Standard Deviation 28.6 |
Secondary
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | 0.8 percent change | Standard Deviation 37.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | 3.4 percent change | Standard Deviation 40.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | 0.6 percent change | Standard Deviation 39.9 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | 4.3 percent change | Standard Deviation 43.3 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | 9.1 percent change | Standard Deviation 53.2 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -1.2 percent change | Standard Deviation 35.3 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | 5.0 percent change | Standard Deviation 38 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -22.1 percent change | Standard Deviation 21.9 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | 1.0 percent change | Standard Deviation 45.9 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | 7.7 percent change | Standard Deviation 49.8 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | 3.6 percent change | Standard Deviation 42.9 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | 9.3 percent change | Standard Deviation 55.2 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | 10.8 percent change | Standard Deviation 48.5 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | 5.1 percent change | Standard Deviation 78 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | 3.5 percent change | Standard Deviation 47 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -10.3 percent change | Standard Deviation 27.1 |
| Alirocumab: All Participants | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | 0.9 percent change | Standard Deviation 44 |
| Alirocumab: All Participants | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | 3.5 percent change | Standard Deviation 44.9 |
| Alirocumab: All Participants | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | 3.7 percent change | Standard Deviation 67.2 |
| Alirocumab: All Participants | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | 3.8 percent change | Standard Deviation 43 |
| Alirocumab: All Participants | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | 6.8 percent change | Standard Deviation 45.9 |
| Alirocumab: All Participants | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | 6.7 percent change | Standard Deviation 44.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | 9.2 percent change | Standard Deviation 54.5 |
| Alirocumab: All Participants | Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -15.0 percent change | Standard Deviation 24.6 |
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | 5.6 percent change | Standard Deviation 17.1 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | 5.7 percent change | Standard Deviation 17.4 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | 7.1 percent change | Standard Deviation 17.8 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | 6.7 percent change | Standard Deviation 17.6 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | 7.2 percent change | Standard Deviation 18.8 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | 8.0 percent change | Standard Deviation 18.4 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | 8.8 percent change | Standard Deviation 19.2 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -6.6 percent change | Standard Deviation 26.2 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | 7.2 percent change | Standard Deviation 19.2 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | 8.8 percent change | Standard Deviation 24.8 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | 7.2 percent change | Standard Deviation 19.9 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | 7.2 percent change | Standard Deviation 18.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | 8.1 percent change | Standard Deviation 18.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | 6.6 percent change | Standard Deviation 17.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | 5.8 percent change | Standard Deviation 16.9 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -0.3 percent change | Standard Deviation 9.9 |
| Alirocumab: All Participants | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | 7.2 percent change | Standard Deviation 18.7 |
| Alirocumab: All Participants | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | 5.8 percent change | Standard Deviation 17.1 |
| Alirocumab: All Participants | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | 6.3 percent change | Standard Deviation 17.3 |
| Alirocumab: All Participants | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | 7.0 percent change | Standard Deviation 19.1 |
| Alirocumab: All Participants | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | 8.8 percent change | Standard Deviation 23 |
| Alirocumab: All Participants | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | 8.1 percent change | Standard Deviation 18.6 |
| Alirocumab: All Participants | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | 7.2 percent change | Standard Deviation 18.7 |
| Alirocumab: All Participants | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -2.8 percent change | Standard Deviation 17.1 |
Secondary
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 48, 96, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 48 | -15.0 percent change | Standard Deviation 158.4 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 96 | -13.9 percent change | Standard Deviation 171.7 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 144 | -20.1 percent change | Standard Deviation 46.1 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 168 | -30.3 percent change | Standard Deviation 18.2 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 168 | -29.2 percent change | Standard Deviation 15.4 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 48 | -26.4 percent change | Standard Deviation 40.2 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 144 | -33.0 percent change | Standard Deviation 25 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 96 | -21.4 percent change | Standard Deviation 132.7 |
| Alirocumab: All Participants | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 168 | -29.6 percent change | Standard Deviation 15.6 |
| Alirocumab: All Participants | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 96 | -18.9 percent change | Standard Deviation 146.9 |
| Alirocumab: All Participants | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 144 | -28.5 percent change | Standard Deviation 34.3 |
| Alirocumab: All Participants | Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 | Week 48 | -22.6 percent change | Standard Deviation 97.6 |
Secondary
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -38.1 percent change | Standard Deviation 24.8 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -40.6 percent change | Standard Deviation 25.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -39.7 percent change | Standard Deviation 25.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -40.8 percent change | Standard Deviation 22.6 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -39.9 percent change | Standard Deviation 23.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -41.4 percent change | Standard Deviation 22.1 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -39.8 percent change | Standard Deviation 22.9 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -40.7 percent change | Standard Deviation 12.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -40.6 percent change | Standard Deviation 27.6 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -41.8 percent change | Standard Deviation 24 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -40.3 percent change | Standard Deviation 26.5 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -40.5 percent change | Standard Deviation 26.6 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -38.4 percent change | Standard Deviation 29.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -37.6 percent change | Standard Deviation 26.6 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -40.4 percent change | Standard Deviation 27.9 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -47.7 percent change | Standard Deviation 18.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -40.3 percent change | Standard Deviation 26.9 |
| Alirocumab: All Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -40.5 percent change | Standard Deviation 27.1 |
| Alirocumab: All Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -37.8 percent change | Standard Deviation 26 |
| Alirocumab: All Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -40.5 percent change | Standard Deviation 25.3 |
| Alirocumab: All Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -41.1 percent change | Standard Deviation 23.6 |
| Alirocumab: All Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -39.5 percent change | Standard Deviation 27.3 |
| Alirocumab: All Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -40.3 percent change | Standard Deviation 25.6 |
| Alirocumab: All Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -44.9 percent change | Standard Deviation 16.1 |
Secondary
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Population: mITT population. Here, Number analyzed signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -30.1 percent change | Standard Deviation 20.3 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -30.2 percent change | Standard Deviation 17.2 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -32.3 percent change | Standard Deviation 12.4 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -27.9 percent change | Standard Deviation 19.3 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -29.0 percent change | Standard Deviation 20.5 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -29.9 percent change | Standard Deviation 18 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -29.1 percent change | Standard Deviation 18.2 |
| Placebo to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -28.9 percent change | Standard Deviation 18.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -30.1 percent change | Standard Deviation 20.8 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -30.0 percent change | Standard Deviation 21.6 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -28.4 percent change | Standard Deviation 22.8 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -31.3 percent change | Standard Deviation 19.1 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -30.2 percent change | Standard Deviation 21.6 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -27.7 percent change | Standard Deviation 20.7 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -39.1 percent change | Standard Deviation 14.3 |
| Alirocumab to Alirocumab 75 or 150 mg Q2W | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -29.9 percent change | Standard Deviation 21.1 |
| Alirocumab: All Participants | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 168 | -36.4 percent change | Standard Deviation 13.3 |
| Alirocumab: All Participants | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 8 | -27.7 percent change | Standard Deviation 20.2 |
| Alirocumab: All Participants | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 24 | -30.1 percent change | Standard Deviation 21.2 |
| Alirocumab: All Participants | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 48 | -29.7 percent change | Standard Deviation 21.2 |
| Alirocumab: All Participants | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 72 | -30.0 percent change | Standard Deviation 19.9 |
| Alirocumab: All Participants | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 96 | -29.6 percent change | Standard Deviation 20.2 |
| Alirocumab: All Participants | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 144 | -30.5 percent change | Standard Deviation 18.8 |
| Alirocumab: All Participants | Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 | Week 120 | -29.0 percent change | Standard Deviation 21 |