Heterozygous Familial Hypercholesterolemia, Hypercholesterolemia
Conditions
Brief summary
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
Interventions
DRUGAlirocumab
Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
DRUGPlacebo Matched to Alirocumab
Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Prior participation in and the successful completion of the R727-CL-1003 study (NCT01266876). 2. Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study 3. A negative urine pregnancy at the screening/baseline visit for women of childbearing potential Key
Exclusion criteria
1. Reported a drug-related serious adverse event (SAE) or drug-related clinical or laboratory adverse event (AE) in the R727-CL-1003 study that resulted in early termination or withdrawal 2. Significant protocol deviation in R727-CL-1003, such as non-compliance by the investigator or patient 3. Low-density lipoprotein (LDL) apheresis within 12 months before the screening/baseline visit Note: Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Baseline (Day 1 of current study) to end of study (Week 218) | An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12 | Baseline (current study) up to Week 12 | Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Baseline(current study) up to Week 24 | Percent change for Apo B, Non-HDL-C and Total Cholesterol from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Baseline (current study) up to Week 12 | Percent change for serum Apo B, Non-HDL-C, and Total Cholesterol from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52 | Baseline (current study) up to Week 52 | Percent change for serum LDL-C from baseline to Week 52 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24 | At Week 24 | Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported. |
| Percent Change in Lipoprotein a (Lp[a]) at Week 24 | At Week 24 | Percent change in serum lipoprotein a at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 | At Week 24 and 12 | Percent change for serum High Density Lipoprotein Cholesterol (HDL-C) in the current study at weeks 24 and week 12, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Percent Change in Lipoprotein a at Week 12 | At Week 12 | Percent change for serum Lipoprotein a at Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Percent Change in Triglycerides (TG) at Week 24 and Week 12 | At Week 24 and 12 | Percent change for serum TG at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
| Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24 | Baseline (current study) to Week 24 | Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment | Baseline (current study) to the End of Treatment (Week 208) | Percent change for serum LDL-C from baseline to Week 208 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | At Week 12, 52 and End of Treatment (Week 208) | Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 12, 52 and end of treatment, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported. |
| Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208) | Absolute change was reported for serum LDL-C from baseline to weeks 12, 24, 52, and end of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Baseline (current study) up to Weeks 52 and End of Treatment (Week 208) | Percent change was reported for serum (Apo B), non-HDL-C, total-C, Lp(a), HDL-C, TG, and Apo A-1 from baseline to weeks 52 and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208) | Change in ratio in Apolipoprotein (Apo) B/Apo A-1 from baseline in current Study to week 12, 24, 52, and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | At Week 12, 24, 52, and End of Treatment (Week 208) | Percentage of participants was calculated with Apo B \<80 mg/dL (0.8 mmol/L) at week 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | At Week 12, 24, 52, and End of Treatment (Week 208) | Percentage of participants was calculated with non-HDL-C \<100 mg/dL (2.59 mmol/L) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | At Week 12, 24, 52, and End of Treatment (Week 208) | Percentage of Participants was calculated with LDL-C \<70 mg/dL (1.81 mmol/L) and/or ≥ 50% Reduction in LDL-C (if LDL-C \>70 mg/dL \[1.81 mmol/L\]) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study. |
| Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 | At Week 24 and Week 12 | Percent change for serum Apo A-1 at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported. |
Countries
Canada, United States
Participant flow
Recruitment details
The study was conducted at 15 sites in the United States and Canada between 28 Feb 2012 and 22 Dec 2016. A total of 59 participants were screened in the study.
Pre-assignment details
Out of 59, 58 participants received alirocumab in this open-label extension study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants in Parent Study Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | 12 |
| Participants Previously Exposed to Alirocumab in Parent Study Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | 46 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Other | 2 | 5 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Sponsor Decision | 2 | 8 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Participants Previously Exposed to Alirocumab in Parent Study | Total | Placebo Participants in Parent Study |
|---|---|---|---|
| Age, Continuous | 54.3 Years STANDARD_DEVIATION 9.4 | 54.4 Years STANDARD_DEVIATION 9.4 | 54.9 Years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 54 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 55 Participants | 11 Participants |
| Sex: Female, Male Female | 14 Participants | 20 Participants | 6 Participants |
| Sex: Female, Male Male | 32 Participants | 38 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 46 |
| other Total, other adverse events | 12 / 12 | 38 / 46 |
| serious Total, serious adverse events | 4 / 12 | 8 / 46 |
Outcome results
Primary
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Time frame: Baseline (Day 1 of current study) to end of study (Week 218)
Population: Safety Analysis Set (SAF) included all participants who received at least 1 dose or part of a dose of alirocumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Participants in Parent Study | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Adverse Events Leading to Death | 0 Participants |
| Placebo Participants in Parent Study | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Adverse Events | 12 Participants |
| Placebo Participants in Parent Study | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Serious Adverse Events | 4 Participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Adverse Events Leading to Death | 0 Participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Serious Adverse Events | 8 Participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Adverse Events | 42 Participants |
| All Participants | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Adverse Events Leading to Death | 0 Participants |
| All Participants | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Serious Adverse Events | 12 Participants |
| All Participants | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Adverse Events | 54 Participants |
Secondary
Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment
Absolute change was reported for serum LDL-C from baseline to weeks 12, 24, 52, and end of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Participants in Parent Study | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 12 | -92.0 Milligram per Deciliter (mg/dL) | Standard Deviation 54.3 |
| Placebo Participants in Parent Study | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 24 | -113.2 Milligram per Deciliter (mg/dL) | Standard Deviation 24.9 |
| Placebo Participants in Parent Study | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 52 | -87.0 Milligram per Deciliter (mg/dL) | Standard Deviation 44.5 |
| Placebo Participants in Parent Study | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 208 | -80.3 Milligram per Deciliter (mg/dL) | Standard Deviation 38.7 |
| Participants Previously Exposed to Alirocumab in Parent Study | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 208 | -78.1 Milligram per Deciliter (mg/dL) | Standard Deviation 33.6 |
| Participants Previously Exposed to Alirocumab in Parent Study | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 12 | -96.8 Milligram per Deciliter (mg/dL) | Standard Deviation 44.7 |
| Participants Previously Exposed to Alirocumab in Parent Study | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 52 | -83.8 Milligram per Deciliter (mg/dL) | Standard Deviation 58.6 |
| Participants Previously Exposed to Alirocumab in Parent Study | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 24 | -95.3 Milligram per Deciliter (mg/dL) | Standard Deviation 40 |
| All Participants | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 208 | -78.5 Milligram per Deciliter (mg/dL) | Standard Deviation 33.2 |
| All Participants | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 24 | -98.9 Milligram per Deciliter (mg/dL) | Standard Deviation 37.9 |
| All Participants | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 52 | -84.5 Milligram per Deciliter (mg/dL) | Standard Deviation 55.4 |
| All Participants | Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment | Week 12 | -95.8 Milligram per Deciliter (mg/dL) | Standard Deviation 46.4 |
Secondary
Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment.
Change in ratio in Apolipoprotein (Apo) B/Apo A-1 from baseline in current Study to week 12, 24, 52, and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Participants in Parent Study | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 208 | -0.330 Ratio | Standard Deviation 0.165 |
| Placebo Participants in Parent Study | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 24 | -0.450 Ratio | Standard Deviation 0.162 |
| Placebo Participants in Parent Study | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 52 | -0.385 Ratio | Standard Deviation 0.21 |
| Placebo Participants in Parent Study | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 12 | -0.397 Ratio | Standard Deviation 0.234 |
| Participants Previously Exposed to Alirocumab in Parent Study | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 52 | -0.416 Ratio | Standard Deviation 0.295 |
| Participants Previously Exposed to Alirocumab in Parent Study | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 208 | -0.402 Ratio | Standard Deviation 0.164 |
| Participants Previously Exposed to Alirocumab in Parent Study | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 12 | -0.456 Ratio | Standard Deviation 0.23 |
| Participants Previously Exposed to Alirocumab in Parent Study | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 24 | -0.460 Ratio | Standard Deviation 0.211 |
| All Participants | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 208 | -0.389 Ratio | Standard Deviation 0.161 |
| All Participants | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 24 | -0.458 Ratio | Standard Deviation 0.201 |
| All Participants | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 52 | -0.410 Ratio | Standard Deviation 0.278 |
| All Participants | Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. | Change at Week 12 | -0.444 Ratio | Standard Deviation 0.23 |
Secondary
Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment
Percentage of participants was calculated with Apo B \<80 mg/dL (0.8 mmol/L) at week 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: At Week 12, 24, 52, and End of Treatment (Week 208)
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Participants in Parent Study | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 208 | 100.00 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 12 | 66.67 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 52 | 66.67 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 24 | 91.67 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 52 | 73.81 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 208 | 85.71 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 24 | 81.82 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 12 | 79.55 percentage of participants |
| All Participants | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 208 | 88.24 percentage of participants |
| All Participants | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 24 | 83.93 percentage of participants |
| All Participants | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 52 | 72.22 percentage of participants |
| All Participants | Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment | Week 12 | 76.79 percentage of participants |
Secondary
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment
Percentage of Participants was calculated with LDL-C \<70 mg/dL (1.81 mmol/L) and/or ≥ 50% Reduction in LDL-C (if LDL-C \>70 mg/dL \[1.81 mmol/L\]) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: At Week 12, 24, 52, and End of Treatment (Week 208)
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Participants in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 12 | 66.67 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 24 | 100.00 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 52 | 75.00 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 208 | 66.67 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 12 | 86.36 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 208 | 85.71 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 52 | 73.81 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 24 | 81.82 percentage of participants |
| All Participants | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 24 | 85.45 percentage of participants |
| All Participants | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 12 | 82.14 percentage of participants |
| All Participants | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 52 | 74.07 percentage of participants |
| All Participants | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment | Week 208 | 82.35 percentage of participants |
Secondary
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment
Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 12, 52 and end of treatment, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.
Time frame: At Week 12, 52 and End of Treatment (Week 208)
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Participants in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | Week 52 | 75.00 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | Week 12 | 83.33 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | End of Treatment (Week 208) | 100 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | Week 52 | 83.33 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | Week 12 | 90.91 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | End of Treatment (Week 208) | 85.71 percentage of participants |
| All Participants | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | Week 12 | 89.29 percentage of participants |
| All Participants | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | End of Treatment (Week 208) | 88.24 percentage of participants |
| All Participants | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment | Week 52 | 81.48 percentage of participants |
Secondary
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24
Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.
Time frame: At Week 24
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Participants in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24 | 100.00 Percentage of Participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24 | 90.91 Percentage of Participants |
| All Participants | Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24 | 92.73 Percentage of Participants |
Secondary
Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment
Percentage of participants was calculated with non-HDL-C \<100 mg/dL (2.59 mmol/L) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: At Week 12, 24, 52, and End of Treatment (Week 208)
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Participants in Parent Study | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 12 | 58.33 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 24 | 91.67 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 52 | 58.33 percentage of participants |
| Placebo Participants in Parent Study | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 208 | 66.67 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 208 | 78.57 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 12 | 75.00 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 52 | 73.81 percentage of participants |
| Participants Previously Exposed to Alirocumab in Parent Study | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 24 | 81.82 percentage of participants |
| All Participants | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 208 | 76.47 percentage of participants |
| All Participants | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 24 | 83.93 percentage of participants |
| All Participants | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 52 | 70.37 percentage of participants |
| All Participants | Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment | Week 12 | 71.43 percentage of participants |
Secondary
Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12
Percent change for serum Apo A-1 at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 24 and Week 12
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 | Week 24 | 5.41 percent change | Standard Deviation 11.96 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 | Week 12 | 11.10 percent change | Standard Deviation 11.43 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 | Week 24 | 4.78 percent change | Standard Deviation 11.2 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 | Week 12 | 8.64 percent change | Standard Deviation 10.99 |
| All Participants | Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 | Week 24 | 4.91 percent change | Standard Deviation 11.24 |
| All Participants | Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 | Week 12 | 9.13 percent change | Standard Deviation 11.02 |
Secondary
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12
Percent change for serum Apo B, Non-HDL-C, and Total Cholesterol from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) up to Week 12
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Non-HDL- C | -47.81 percent change | Standard Deviation 32.92 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Apo- B | -40.69 percent change | Standard Deviation 30.46 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Total Cholesterol | -36.78 percent change | Standard Deviation 24.88 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Non-HDL- C | -54.97 percent change | Standard Deviation 22.85 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Apo- B | -48.78 percent change | Standard Deviation 20.24 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Total Cholesterol | -40.47 percent change | Standard Deviation 16.93 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Apo- B | -47.16 percent change | Standard Deviation 22.56 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Total Cholesterol | -39.68 percent change | Standard Deviation 18.72 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 | Non-HDL- C | -53.44 percent change | Standard Deviation 25.18 |
Secondary
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24
Percent change for Apo B, Non-HDL-C and Total Cholesterol from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline(current study) up to Week 24
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Non-HDL-C | -56.75 percent change | Standard Deviation 21.8 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Apo B | -52.23 percent change | Standard Deviation 20.3 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Total cholesterol | -42.72 percent change | Standard Deviation 15.3 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Non-HDL-C | -55.43 percent change | Standard Deviation 20.97 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Apo B | -50.52 percent change | Standard Deviation 18.18 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Total cholesterol | -41.47 percent change | Standard Deviation 16.37 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Apo B | -50.86 percent change | Standard Deviation 18.43 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Total cholesterol | -41.74 percent change | Standard Deviation 16.02 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 | Non-HDL-C | -55.71 percent change | Standard Deviation 20.95 |
Secondary
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment
Percent change was reported for serum (Apo B), non-HDL-C, total-C, Lp(a), HDL-C, TG, and Apo A-1 from baseline to weeks 52 and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) up to Weeks 52 and End of Treatment (Week 208)
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | TG : Week 52 | -6.04 percent change | Standard Deviation 41.12 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Total -C : Week 208 | -35.33 percent change | Standard Deviation 11.92 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Non- HDL-C: Week 52 | -47.10 percent change | Standard Deviation 27.26 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | HDL-C: Week 208 | -9.83 percent change | Standard Deviation 12.49 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Lp-(a): Week 52 | -24.77 percent change | Standard Deviation 25.14 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo B : Week 208 | -45.02 percent change | Standard Deviation 17.58 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | HDL-C: Week 52 | 5.40 percent change | Standard Deviation 17.64 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Lp-(a): Week 208 | -23.92 percent change | Standard Deviation 39.92 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | TG : Week 208 | 16.69 percent change | Standard Deviation 28.93 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Non- HDL-C: Week 208 | -43.29 percent change | Standard Deviation 17.98 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo A-1 : Week 208 | -1.46 percent change | Standard Deviation 4.48 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo B : Week 52 | -43.04 percent change | Standard Deviation 25.6 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Total -C : Week 52 | -35.09 percent change | Standard Deviation 19.16 |
| Placebo Participants in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo A-1 : Week 52 | 6.76 percent change | Standard Deviation 10.82 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | TG : Week 52 | -3.84 percent change | Standard Deviation 40.25 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo B : Week 52 | -45.17 percent change | Standard Deviation 28.51 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo B : Week 208 | -48.07 percent change | Standard Deviation 18.61 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Non- HDL-C: Week 52 | -48.60 percent change | Standard Deviation 31.71 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Non- HDL-C: Week 208 | -50.34 percent change | Standard Deviation 21.4 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Total -C : Week 52 | -36.41 percent change | Standard Deviation 24.89 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Total -C : Week 208 | -37.01 percent change | Standard Deviation 16.59 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Lp-(a): Week 52 | -22.91 percent change | Standard Deviation 30.33 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Lp-(a): Week 208 | -31.29 percent change | Standard Deviation 30.2 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | HDL-C: Week 52 | 7.74 percent change | Standard Deviation 14.21 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | HDL-C: Week 208 | 4.94 percent change | Standard Deviation 11.25 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | TG : Week 208 | -5.28 percent change | Standard Deviation 23.05 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo A-1 : Week 52 | 3.90 percent change | Standard Deviation 10.8 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo A-1 : Week 208 | 9.53 percent change | Standard Deviation 7.45 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo A-1 : Week 52 | 4.49 percent change | Standard Deviation 10.76 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | HDL-C: Week 208 | 2.34 percent change | Standard Deviation 12.49 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Total -C : Week 52 | -36.11 percent change | Standard Deviation 23.57 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Non- HDL-C: Week 208 | -49.10 percent change | Standard Deviation 20.5 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | TG : Week 52 | -4.33 percent change | Standard Deviation 40.07 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Non- HDL-C: Week 52 | -48.27 percent change | Standard Deviation 30.54 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo B : Week 52 | -44.73 percent change | Standard Deviation 27.71 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | TG : Week 208 | -1.40 percent change | Standard Deviation 24.71 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo B : Week 208 | -47.53 percent change | Standard Deviation 17.93 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Lp-(a): Week 208 | -29.99 percent change | Standard Deviation 30.8 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Lp-(a): Week 52 | -23.30 percent change | Standard Deviation 29.11 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Apo A-1 : Week 208 | 7.59 percent change | Standard Deviation 8.14 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | HDL-C: Week 52 | 7.22 percent change | Standard Deviation 14.89 |
| All Participants | Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment | Total -C : Week 208 | -36.72 percent change | Standard Deviation 15.55 |
Secondary
Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12
Percent change for serum High Density Lipoprotein Cholesterol (HDL-C) in the current study at weeks 24 and week 12, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 24 and 12
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 | Week 24 | 2.61 percent change | Standard Deviation 15.75 |
| Placebo Participants in Parent Study | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 | Week 12 | 1.46 percent change | Standard Deviation 14.08 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 | Week 24 | 7.14 percent change | Standard Deviation 16.04 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 | Week 12 | 10.43 percent change | Standard Deviation 15.98 |
| All Participants | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 | Week 24 | 6.17 percent change | Standard Deviation 15.94 |
| All Participants | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 | Week 12 | 8.51 percent change | Standard Deviation 15.91 |
Secondary
Percent Change in Lipoprotein a at Week 12
Percent change for serum Lipoprotein a at Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 12
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Lipoprotein a at Week 12 | -20.30 percent change | Standard Deviation 24.1 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Lipoprotein a at Week 12 | -26.98 percent change | Standard Deviation 22.71 |
| All Participants | Percent Change in Lipoprotein a at Week 12 | -25.64 percent change | Standard Deviation 22.92 |
Secondary
Percent Change in Lipoprotein a (Lp[a]) at Week 24
Percent change in serum lipoprotein a at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 24
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Lipoprotein a (Lp[a]) at Week 24 | -27.91 percent change | Standard Deviation 23.62 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Lipoprotein a (Lp[a]) at Week 24 | -29.41 percent change | Standard Deviation 25.01 |
| All Participants | Percent Change in Lipoprotein a (Lp[a]) at Week 24 | -29.11 percent change | Standard Deviation 24.53 |
Secondary
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12
Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) up to Week 12
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12 | -55.93 percent change | Standard Deviation 29.53 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12 | -63.94 percent change | Standard Deviation 23.35 |
| All Participants | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12 | -62.22 percent change | Standard Deviation 24.73 |
Secondary
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52
Percent change for serum LDL-C from baseline to Week 52 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) up to Week 52
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52 | -54.57 percent change | Standard Deviation 26.2 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52 | -55.67 percent change | Standard Deviation 34.41 |
| All Participants | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52 | -55.43 percent change | Standard Deviation 32.53 |
Secondary
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment
Percent change for serum LDL-C from baseline to Week 208 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) to the End of Treatment (Week 208)
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment | -52.20 percent change | Standard Deviation 16.86 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment | -58.46 percent change | Standard Deviation 23.51 |
| All Participants | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment | -57.36 percent change | Standard Deviation 22.15 |
Secondary
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24
Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) to Week 24
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24 | -73.15 percent change | Standard Deviation 15.01 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24 | -63.40 percent change | Standard Deviation 22.04 |
| All Participants | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24 | -65.35 percent change | Standard Deviation 21.07 |
Secondary
Percent Change in Triglycerides (TG) at Week 24 and Week 12
Percent change for serum TG at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 24 and 12
Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, Number analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Participants in Parent Study | Percent Change in Triglycerides (TG) at Week 24 and Week 12 | Week 24 | 0.19 percent change | Standard Deviation 54.71 |
| Placebo Participants in Parent Study | Percent Change in Triglycerides (TG) at Week 24 and Week 12 | Week 12 | -6.40 percent change | Standard Deviation 46.11 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Triglycerides (TG) at Week 24 and Week 12 | Week 24 | -2.01 percent change | Standard Deviation 41.22 |
| Participants Previously Exposed to Alirocumab in Parent Study | Percent Change in Triglycerides (TG) at Week 24 and Week 12 | Week 12 | 0.52 percent change | Standard Deviation 34.17 |
| All Participants | Percent Change in Triglycerides (TG) at Week 24 and Week 12 | Week 12 | -0.96 percent change | Standard Deviation 36.69 |
| All Participants | Percent Change in Triglycerides (TG) at Week 24 and Week 12 | Week 24 | -1.54 percent change | Standard Deviation 43.91 |