Severe Familial Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, Elevated Cholesterol, High Cholesterol, Homozygous Familial Hypercholesterolemia, PCSK9 mutations, Severe Familial Hypercholesterolemia
Brief summary
A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.
Detailed description
This phase 2/3 open-label extension study was designed to characterize the safety and tolerability of long-term administration of evolocumab to adults and adolescents with severe FH (HoFH or non-HoFH severe FH). Participants not on lipid apheresis at enrollment or within the prior 8 weeks initiated treatment with evolocumab 420 mg once monthly (QM). Participants on lipid apheresis at enrollment initiated treatment with evolocumab 420 mg once every 2 weeks (Q2W). Dose frequency changes (420 mg QM vs 420 mg Q2W) were permitted at week 12, 24, or other visits with Sponsor approval. Participants with \< 5% LDL-C reduction from baseline and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) \< 100 ng/mL could discontinue evolocumab. If serum unbound PCSK9 was ≥ 100 ng/mL with QM dosing, the participant could switch to evolocumab 420 mg Q2W treatment. Participants on apheresis with ≥ 5% LDL-C reduction from baseline and serum unbound PCSK9 \< 100 ng/mL with Q2W treatment could switch to QM dosing. Participants were to continue to receive open-label evolocumab for up to 5 years or until evolocumab became commercially available in the relevant patient population, whichever occurred first.
Interventions
BIOLOGICALEvolocumab
Evolocumab was administered by subcutaneous injection either once a month (QM) or once every two weeks (Q2W).
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- Participated in Study 20110233 (NCT01588496) or another qualifying evolocumab parent protocol and have a diagnosis of familial hypercholesterolemia. OR * Have a diagnosis of familial hypercholesterolemia AND * Males and females ≥ 12 to ≤ 80 years of age * Stable low-fat diet and lipid-lowering therapies for at least 4 weeks * Low-density lipoprotein cholesterol (LDL-C) \>= 130 mg/dl (3.4 mmol/L) for subjects without diagnosed coronary heart disease (CHD)/CHD risk equivalent OR LDL-C \>= 100 mg/dl (2.6 mmol/L) for subjects with diagnosed CHD or CHD risk equivalent OR apheresis patients have no LDL-C entry requirement * Fasting triglycerides ≤ 400 mg/dL(4.5 mmol/L) * Body weight of \> 40 kg or greater at screening for subjects less than 18 years of age
Exclusion criteria
* New York Heart Failure Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30% * Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of screening * Planned cardiac surgery or revascularization * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. | The severity of each adverse event (AE) was graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) grading scale, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening AE and grade 5 = death due to AE. |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Percent Change From Baseline in Lipoprotein (a) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Percent Change From Baseline in Apolipoprotein B | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Percentage of Participants With a 15% or Greater Reduction in LDL-C | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
| Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
Countries
Australia, Belgium, Brazil, Canada, Czechia, France, Greece, Hong Kong, Israel, Italy, Japan, Lebanon, Netherlands, New Zealand, South Africa, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 43 centers in Canada, South Africa, Czech Republic, Netherlands, USA, France, Spain, Italy, Belgium, Australia, New Zealand, United Kingdom, Japan, Israel, Greece, Lebanon, Brazil, and Hong Kong between 01 June 2012 and 19 March 2015.
Pre-assignment details
A total of 246 participants enrolled directly in Study 20110271 and 54 participants rolled over from Study 20110233 (NCT01588496). Results are reported separately for participants with homozygous familial hypercholesterolemia (HoFH) and non-HoFH severe familial hypercholesterolemia (FH) (ie, all those not meeting the protocol criteria for HoFH).
Participants by arm
| Arm | Count |
|---|---|
| HoFH Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels. | 106 |
| Severe FH Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels. | 194 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 6 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Study Closure | 12 | 6 |
| Overall Study | Withdrawal by Subject | 14 | 4 |
Baseline characteristics
| Characteristic | HoFH | Severe FH | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 0 Participants | 14 Participants |
| Age, Categorical >=65 years | 4 Participants | 42 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants | 152 Participants | 240 Participants |
| Age, Continuous | 34.3 years STANDARD_DEVIATION 14.4 | 54.7 years STANDARD_DEVIATION 11.9 | 47.5 years STANDARD_DEVIATION 16.1 |
| Apolipoprotein B/Apoliprotein A1 Ratio | 1.984 ratio STANDARD_DEVIATION 0.95 | 1.023 ratio STANDARD_DEVIATION 0.355 | 1.362 ratio STANDARD_DEVIATION 0.781 |
| Apolipoprotein B Concentration | 200.7 mg/dL STANDARD_DEVIATION 69.9 | 139.2 mg/dL STANDARD_DEVIATION 35.6 | 160.9 mg/dL STANDARD_DEVIATION 58.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 22 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 172 Participants | 273 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Lipoprotein (a) Concentration | 104.7 nmol/L STANDARD_DEVIATION 100.6 | 127.1 nmol/L STANDARD_DEVIATION 142.8 | 119.2 nmol/L STANDARD_DEVIATION 129.7 |
| Low-density Lipoprotein Cholesterol (LDL-C) Concentration | 329.0 mg/dL STANDARD_DEVIATION 136.7 | 192.7 mg/dL STANDARD_DEVIATION 64.6 | 240.9 mg/dL STANDARD_DEVIATION 116.3 |
| Non-high-density Lipoprotein Cholesterol (non-HDL-C) Concentration | 350.5 mg/dL STANDARD_DEVIATION 138.4 | 222.1 mg/dL STANDARD_DEVIATION 68.3 | 267.5 mg/dL STANDARD_DEVIATION 116.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 3 Participants | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Mixed Race | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 85 Participants | 179 Participants | 264 Participants |
| Sex: Female, Male Female | 54 Participants | 78 Participants | 132 Participants |
| Sex: Female, Male Male | 52 Participants | 116 Participants | 168 Participants |
| Total Cholesterol/HDL-C Ratio | 11.473 ratio STANDARD_DEVIATION 6.312 | 6.055 ratio STANDARD_DEVIATION 2.397 | 7.970 ratio STANDARD_DEVIATION 4.943 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 106 | 6 / 194 | 9 / 300 |
| other Total, other adverse events | 80 / 106 | 134 / 194 | 214 / 300 |
| serious Total, serious adverse events | 29 / 106 | 57 / 194 | 86 / 300 |
Outcome results
Primary
Number of Participants With Adverse Events
The severity of each adverse event (AE) was graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) grading scale, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening AE and grade 5 = death due to AE.
Time frame: From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.
Population: All participants who received at least one dose of evolocumab in Study 20110271
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HoFH | Number of Participants With Adverse Events | Serious adverse events (SAEs) | 29 Participants |
| HoFH | Number of Participants With Adverse Events | Adverse events ≥ grade 4 | 4 Participants |
| HoFH | Number of Participants With Adverse Events | AEs Leading to discontinuation of evolocumab | 3 Participants |
| HoFH | Number of Participants With Adverse Events | Adverse events ≥ grade 2 | 76 Participants |
| HoFH | Number of Participants With Adverse Events | Fatal adverse events | 2 Participants |
| HoFH | Number of Participants With Adverse Events | All adverse events (AEs) | 94 Participants |
| HoFH | Number of Participants With Adverse Events | Device-related adverse events | 6 Participants |
| HoFH | Number of Participants With Adverse Events | Adverse events ≥ grade 3 | 38 Participants |
| Severe FH | Number of Participants With Adverse Events | Device-related adverse events | 18 Participants |
| Severe FH | Number of Participants With Adverse Events | Serious adverse events (SAEs) | 57 Participants |
| Severe FH | Number of Participants With Adverse Events | All adverse events (AEs) | 174 Participants |
| Severe FH | Number of Participants With Adverse Events | Adverse events ≥ grade 2 | 143 Participants |
| Severe FH | Number of Participants With Adverse Events | Adverse events ≥ grade 3 | 68 Participants |
| Severe FH | Number of Participants With Adverse Events | AEs Leading to discontinuation of evolocumab | 8 Participants |
| Severe FH | Number of Participants With Adverse Events | Fatal adverse events | 5 Participants |
| Severe FH | Number of Participants With Adverse Events | Adverse events ≥ grade 4 | 14 Participants |
Secondary
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Time frame: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 204 | 65.3 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 4 | 62.1 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 120 | 64.6 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 6 | 51.8 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 216 | 70.6 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 8 | 57.4 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 132 | 61.7 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 12 | 56.7 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 96 | 65.9 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 16 | 63.7 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 144 | 72.2 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 20 | 64.4 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 180 | 63.5 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 24 | 66.7 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 156 | 68.8 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 36 | 62.8 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 108 | 61.0 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 48 | 60.2 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 168 | 59.2 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 60 | 60.2 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 192 | 66.2 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 72 | 69.4 percentage of participants |
| HoFH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 84 | 65.9 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 72 | 94.0 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 180 | 93.4 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 204 | 93.8 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 216 | 88.5 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 84 | 93.9 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 96 | 94.4 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 108 | 96.1 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 120 | 91.8 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 132 | 92.7 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 144 | 93.3 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 156 | 93.4 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 192 | 91.8 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 4 | 98.9 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 6 | 98.2 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 8 | 97.9 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 12 | 99.0 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 16 | 97.3 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 20 | 98.9 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 24 | 96.3 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 36 | 97.3 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 48 | 97.9 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 60 | 94.1 percentage of participants |
| Severe FH | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Week 168 | 93.6 percentage of participants |
Secondary
Percent Change From Baseline in Apolipoprotein B
Time frame: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 4 | -16.91 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 6 | -16.25 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 8 | -17.57 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 12 | -13.11 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 16 | -18.65 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 20 | -22.60 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 24 | -20.09 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 36 | -16.48 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 48 | -15.90 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 60 | -15.99 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 72 | -20.70 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 84 | -19.52 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 96 | -15.07 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 108 | -19.45 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 120 | -21.58 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 132 | -22.44 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 144 | -21.24 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 156 | -18.30 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 168 | -20.38 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 180 | -19.51 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 192 | -19.38 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 204 | -21.64 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B | Week 216 | -22.68 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 84 | -43.87 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 4 | -43.84 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 156 | -44.04 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 6 | -56.70 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 96 | -42.31 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 8 | -43.95 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 192 | -37.02 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 12 | -45.78 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 108 | -46.30 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 16 | -45.72 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 168 | -40.20 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 20 | -45.16 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 120 | -44.33 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 24 | -44.87 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 216 | -35.95 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 36 | -43.33 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 132 | -43.48 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 48 | -45.38 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 180 | -41.58 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 60 | -44.81 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 144 | -41.64 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 72 | -44.07 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B | Week 204 | -43.19 percent change |
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Time frame: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 4 | -23.06 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 6 | -21.38 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 8 | -21.53 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 12 | -16.67 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 16 | -22.52 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 20 | -25.41 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 24 | -22.97 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 36 | -26.86 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 48 | -25.96 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 60 | -24.31 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 72 | -23.63 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 84 | -24.09 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 96 | -24.75 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 108 | -26.03 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 120 | -26.45 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 132 | -24.26 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 144 | -28.09 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 156 | -27.21 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 168 | -32.16 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 180 | -28.70 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 192 | -27.50 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 204 | -28.04 percent change |
| HoFH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 216 | -28.37 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 84 | -49.47 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 4 | -46.79 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 156 | -49.10 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 6 | -59.77 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 96 | -48.45 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 8 | -47.82 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 192 | -43.40 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 12 | -48.63 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 108 | -50.18 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 16 | -48.98 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 168 | -44.46 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 20 | -49.12 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 120 | -49.75 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 24 | -49.92 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 216 | -44.00 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 36 | -49.02 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 132 | -48.54 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 48 | -49.35 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 180 | -45.13 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 60 | -48.57 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 144 | -47.44 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 72 | -48.94 percent change |
| Severe FH | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Week 204 | -49.71 percent change |
Secondary
Percent Change From Baseline in Lipoprotein (a)
Time frame: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 4 | -11.11 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 6 | -8.97 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 8 | -9.95 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 12 | -7.69 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 16 | -8.93 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 20 | -13.52 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 24 | -10.46 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 36 | -15.14 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 48 | -13.17 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 60 | -13.04 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 72 | -17.43 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 84 | -14.12 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 96 | -17.24 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 108 | -21.43 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 120 | -20.16 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 132 | -19.15 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 144 | -23.64 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 156 | -18.40 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 168 | -22.94 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 180 | -17.29 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 192 | -22.78 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 204 | -16.33 percent change |
| HoFH | Percent Change From Baseline in Lipoprotein (a) | Week 216 | -14.06 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 84 | -24.12 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 4 | -20.49 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 156 | -28.10 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 6 | -24.42 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 96 | -31.28 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 8 | -21.51 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 192 | -20.00 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 12 | -24.40 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 108 | -32.44 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 16 | -23.08 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 168 | -23.96 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 20 | -22.21 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 120 | -31.22 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 24 | -25.99 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 216 | -0.67 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 36 | -24.26 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 132 | -29.32 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 48 | -26.32 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 180 | -26.23 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 60 | -24.05 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 144 | -30.36 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 72 | -24.23 percent change |
| Severe FH | Percent Change From Baseline in Lipoprotein (a) | Week 204 | -14.29 percent change |
Secondary
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -20.42 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -18.32 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -20.28 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 12 | -18.26 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 16 | -23.15 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 20 | -25.37 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 24 | -21.84 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 36 | -26.79 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 48 | -25.50 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 60 | -27.26 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 72 | -27.11 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 84 | -27.96 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 96 | -22.47 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 108 | -26.15 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 120 | -26.66 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 132 | -28.25 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 144 | -28.33 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 156 | -23.65 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 168 | -29.52 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 180 | -25.66 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 192 | -30.12 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 204 | -29.62 percent change |
| HoFH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 216 | -32.22 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 84 | -56.02 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -54.95 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 156 | -55.38 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -67.57 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 96 | -57.10 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -55.03 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 192 | -52.19 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 12 | -57.11 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 108 | -60.57 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 16 | -57.53 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 168 | -54.77 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 20 | -57.26 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 120 | -56.76 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 24 | -57.10 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 216 | -50.62 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 36 | -56.08 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 132 | -55.25 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 48 | -59.67 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 180 | -54.08 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 60 | -57.13 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 144 | -56.48 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 72 | -55.73 percent change |
| Severe FH | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Week 204 | -59.59 percent change |
Secondary
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 4 | -19.62 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 6 | -18.17 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 8 | -20.29 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 12 | -17.05 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 16 | -21.73 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 20 | -24.09 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 24 | -21.88 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 36 | -22.43 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 48 | -24.08 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 60 | -24.81 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 72 | -25.88 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 84 | -21.00 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 96 | -21.10 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 108 | -24.17 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 120 | -23.21 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 132 | -26.39 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 144 | -25.38 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 156 | -22.35 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 168 | -27.97 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 180 | -26.32 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 192 | -27.61 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 204 | -27.22 percent change |
| HoFH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 216 | -31.40 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 84 | -49.50 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 4 | -50.00 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 156 | -50.15 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 6 | -59.76 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 96 | -49.53 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 8 | -50.61 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 192 | -44.50 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 12 | -50.25 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 108 | -52.86 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 16 | -51.31 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 168 | -47.93 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 20 | -50.76 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 120 | -49.45 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 24 | -51.12 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 216 | -45.30 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 36 | -49.65 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 132 | -49.49 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 48 | -51.12 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 180 | -48.43 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 60 | -49.73 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 144 | -49.81 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 72 | -48.94 percent change |
| Severe FH | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 204 | -50.84 percent change |
Secondary
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Time frame: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 4 | -21.32 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 6 | -23.25 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 8 | -23.93 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 12 | -21.20 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 16 | -24.01 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 20 | -24.69 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 24 | -23.53 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 36 | -27.16 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 48 | -26.54 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 60 | -22.80 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 72 | -24.79 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 84 | -22.62 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 96 | -23.00 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 108 | -25.03 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 120 | -25.40 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 132 | -25.66 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 144 | -27.79 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 156 | -25.52 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 168 | -26.30 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 180 | -29.53 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 192 | -27.79 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 204 | -27.32 percent change |
| HoFH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 216 | -30.92 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 84 | -43.16 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 4 | -43.49 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 156 | -43.85 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 6 | -52.38 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 96 | -42.46 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 8 | -43.44 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 192 | -38.24 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 12 | -44.75 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 108 | -43.68 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 16 | -45.31 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 168 | -41.59 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 20 | -43.07 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 120 | -42.42 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 24 | -43.79 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 216 | -40.78 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 36 | -42.69 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 132 | -42.14 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 48 | -44.68 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 180 | -40.13 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 60 | -43.82 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 144 | -43.40 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 72 | -42.64 percent change |
| Severe FH | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Week 204 | -43.13 percent change |