Hypercholesterolemia
Conditions
Keywords
High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol
Brief summary
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
Interventions
BIOLOGICALEvolocumab
Administered by subcutaneous injection
OTHERStandard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)
Exclusion criteria
* Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study * Have an unstable medical condition, in the judgment of the investigator * Known sensitivity to any of the products to be administered during dosing * Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months. | Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, 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 |
|---|---|
| Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 |
| Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 |
| Apolipoprotein B Level at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 |
| Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 |
| Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Baseline of parent study and extension study weeks 24 and 52 |
Countries
Australia, Belgium, Canada, Czechia, Denmark, Finland, Germany, Hong Kong, Hungary, Japan, Netherlands, Norway, Singapore, South Africa, Spain, Sweden, United Kingdom, United States
Participant flow
Recruitment details
This extension study was conducted at 188 centers in 18 countries. Participants were enrolled from one of five eligible phase 2 parent studies: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703). Participants were enrolled from October 2011 to June 2013.
Pre-assignment details
Participants were randomized in a 2:1 ratio, irrespective of their treatment assignments during the phase 2 parent study, to either evolocumab plus standard of care (SOC) or SOC alone. Randomization was stratified by the treatment to which the participant was randomized to in the parent study, ie evolocumab or control.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period). | 442 |
| Evolocumab + SOC Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period). | 882 |
| Total | 1,324 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| All-IP Period (Years 2 to 5) | Death | 3 | 13 |
| All-IP Period (Years 2 to 5) | Lost to Follow-up | 21 | 30 |
| All-IP Period (Years 2 to 5) | Other | 14 | 31 |
| All-IP Period (Years 2 to 5) | Reason Missing | 1 | 0 |
| All-IP Period (Years 2 to 5) | Sponsor Decision | 1 | 0 |
| All-IP Period (Years 2 to 5) | Withdrawal by Subject | 30 | 66 |
| SOC-controlled Period (Year 1) | Death | 2 | 1 |
| SOC-controlled Period (Year 1) | Lost to Follow-up | 10 | 5 |
| SOC-controlled Period (Year 1) | Other | 8 | 13 |
| SOC-controlled Period (Year 1) | Reason Missing | 0 | 2 |
| SOC-controlled Period (Year 1) | Sponsor Decision | 0 | 1 |
| SOC-controlled Period (Year 1) | Withdrawal by Subject | 24 | 38 |
Baseline characteristics
| Characteristic | Standard of Care | Evolocumab + SOC | Total |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 11.5 | 56.9 years STANDARD_DEVIATION 11.6 | 57.1 years STANDARD_DEVIATION 11.6 |
| Age, Customized < 65 years | 307 Participants | 632 Participants | 939 Participants |
| Age, Customized ≥ 65 years | 135 Participants | 250 Participants | 385 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 39 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 429 Participants | 843 Participants | 1272 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parent Study Baseline Low-density Lipoprotein Cholesterol (LDL-C) Concentration | 144.6 mg/dL STANDARD_DEVIATION 37.4 | 139.7 mg/dL STANDARD_DEVIATION 36.7 | 141.3 mg/dL STANDARD_DEVIATION 37 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 87 Participants | 168 Participants | 255 Participants |
| Race/Ethnicity, Customized Black or African American | 24 Participants | 54 Participants | 78 Participants |
| Race/Ethnicity, Customized Mixed Race | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 325 Participants | 648 Participants | 973 Participants |
| Region Asia Pacific | 95 Participants | 180 Participants | 275 Participants |
| Region Europe | 133 Participants | 261 Participants | 394 Participants |
| Region North America | 214 Participants | 441 Participants | 655 Participants |
| Sex: Female, Male Female | 241 Participants | 459 Participants | 700 Participants |
| Sex: Female, Male Male | 201 Participants | 423 Participants | 624 Participants |
| Stratification Factor: Parent Study Treatment Assignment Evolocumab every 2 weeks (Q2M) | 129 Participants | 256 Participants | 385 Participants |
| Stratification Factor: Parent Study Treatment Assignment Evolocumab once monthly (QM) | 193 Participants | 387 Participants | 580 Participants |
| Stratification Factor: Parent Study Treatment Assignment No evolocumab | 120 Participants | 239 Participants | 359 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 442 | 1 / 882 | 3 / 398 | 13 / 822 | 16 / 1,220 |
| other Total, other adverse events | 217 / 442 | 513 / 882 | 311 / 398 | 626 / 822 | 937 / 1,220 |
| serious Total, serious adverse events | 30 / 442 | 72 / 882 | 78 / 398 | 181 / 822 | 259 / 1,220 |
Outcome results
Primary
Number of Participants With Adverse Events
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, 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: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.
Population: All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-5).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOC-controlled Period: Standard of Care | Number of Participants With Adverse Events | All adverse events | 327 Participants |
| SOC-controlled Period: Standard of Care | Number of Participants With Adverse Events | Adverse events ≥ grade 3 | 46 Participants |
| SOC-controlled Period: Standard of Care | Number of Participants With Adverse Events | Adverse events ≥ grade 4 | 2 Participants |
| SOC-controlled Period: Standard of Care | Number of Participants With Adverse Events | Serious adverse events | 30 Participants |
| SOC-controlled Period: Standard of Care | Number of Participants With Adverse Events | AEs leading to discontinuation of evolocumab | 0 Participants |
| SOC-controlled Period: Standard of Care | Number of Participants With Adverse Events | Fatal adverse events | 0 Participants |
| SOC-controlled Period: Evolocumab + SOC | Number of Participants With Adverse Events | Fatal adverse events | 0 Participants |
| SOC-controlled Period: Evolocumab + SOC | Number of Participants With Adverse Events | Serious adverse events | 72 Participants |
| SOC-controlled Period: Evolocumab + SOC | Number of Participants With Adverse Events | All adverse events | 728 Participants |
| SOC-controlled Period: Evolocumab + SOC | Number of Participants With Adverse Events | Adverse events ≥ grade 4 | 11 Participants |
| SOC-controlled Period: Evolocumab + SOC | Number of Participants With Adverse Events | Adverse events ≥ grade 3 | 99 Participants |
| SOC-controlled Period: Evolocumab + SOC | Number of Participants With Adverse Events | AEs leading to discontinuation of evolocumab | 28 Participants |
| All-IP Period: SOC / Evolocumab + SOC | Number of Participants With Adverse Events | Adverse events ≥ grade 3 | 111 Participants |
| All-IP Period: SOC / Evolocumab + SOC | Number of Participants With Adverse Events | Adverse events ≥ grade 4 | 8 Participants |
| All-IP Period: SOC / Evolocumab + SOC | Number of Participants With Adverse Events | Serious adverse events | 76 Participants |
| All-IP Period: SOC / Evolocumab + SOC | Number of Participants With Adverse Events | Fatal adverse events | 1 Participants |
| All-IP Period: SOC / Evolocumab + SOC | Number of Participants With Adverse Events | AEs leading to discontinuation of evolocumab | 16 Participants |
| All-IP Period: SOC / Evolocumab + SOC | Number of Participants With Adverse Events | All adverse events | 342 Participants |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Number of Participants With Adverse Events | AEs leading to discontinuation of evolocumab | 27 Participants |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Number of Participants With Adverse Events | Fatal adverse events | 3 Participants |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Number of Participants With Adverse Events | Adverse events ≥ grade 3 | 229 Participants |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Number of Participants With Adverse Events | Serious adverse events | 172 Participants |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Number of Participants With Adverse Events | All adverse events | 718 Participants |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Number of Participants With Adverse Events | Adverse events ≥ grade 4 | 28 Participants |
Secondary
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52
Time frame: Baseline of parent study and extension study weeks 24 and 52
Population: Participants randomized in the extension study 20110110 and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC-controlled Period: Standard of Care | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Parent Study Baseline | 0.759 ratio | Standard Deviation 0.237 |
| SOC-controlled Period: Standard of Care | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 52 | 0.726 ratio | Standard Deviation 0.256 |
| SOC-controlled Period: Standard of Care | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 24 | 0.717 ratio | Standard Deviation 0.242 |
| SOC-controlled Period: Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 52 | 0.394 ratio | Standard Deviation 0.185 |
| SOC-controlled Period: Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Parent Study Baseline | 0.739 ratio | Standard Deviation 0.217 |
| SOC-controlled Period: Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 24 | 0.386 ratio | Standard Deviation 0.178 |
| All-IP Period: SOC / Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 24 | 0.715 ratio | Standard Deviation 0.222 |
| All-IP Period: SOC / Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Parent Study Baseline | 0.764 ratio | Standard Deviation 0.201 |
| All-IP Period: SOC / Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 52 | 0.719 ratio | Standard Deviation 0.216 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Parent Study Baseline | 0.735 ratio | Standard Deviation 0.212 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 24 | 0.385 ratio | Standard Deviation 0.183 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 52 | 0.393 ratio | Standard Deviation 0.186 |
| Evolocumab in Parent Study: SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 52 | 0.729 ratio | Standard Deviation 0.271 |
| Evolocumab in Parent Study: SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Parent Study Baseline | 0.757 ratio | Standard Deviation 0.249 |
| Evolocumab in Parent Study: SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 24 | 0.718 ratio | Standard Deviation 0.25 |
| Evolocumab in Parent Study: Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 24 | 0.387 ratio | Standard Deviation 0.176 |
| Evolocumab in Parent Study: Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Parent Study Baseline | 0.741 ratio | Standard Deviation 0.218 |
| Evolocumab in Parent Study: Evolocumab + SOC | Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 | Week 52 | 0.394 ratio | Standard Deviation 0.185 |
Secondary
Apolipoprotein B Level at Week 24 and Week 52
Time frame: Baseline of parent study and extension study weeks 24 and 52
Population: Participants randomized in the extension study 20110110 and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC-controlled Period: Standard of Care | Apolipoprotein B Level at Week 24 and Week 52 | Week 24 | 107.9 mg/dL | Standard Deviation 26.3 |
| SOC-controlled Period: Standard of Care | Apolipoprotein B Level at Week 24 and Week 52 | Week 52 | 109.5 mg/dL | Standard Deviation 26.8 |
| SOC-controlled Period: Standard of Care | Apolipoprotein B Level at Week 24 and Week 52 | Parent Study Baseline | 113.2 mg/dL | Standard Deviation 25.3 |
| SOC-controlled Period: Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 52 | 61.6 mg/dL | Standard Deviation 23.5 |
| SOC-controlled Period: Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 24 | 60.8 mg/dL | Standard Deviation 23.3 |
| SOC-controlled Period: Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Parent Study Baseline | 110.4 mg/dL | Standard Deviation 23.8 |
| All-IP Period: SOC / Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 52 | 110.7 mg/dL | Standard Deviation 26.3 |
| All-IP Period: SOC / Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Parent Study Baseline | 115.4 mg/dL | Standard Deviation 23.1 |
| All-IP Period: SOC / Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 24 | 110.5 mg/dL | Standard Deviation 27 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 52 | 61.7 mg/dL | Standard Deviation 23 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Parent Study Baseline | 110.3 mg/dL | Standard Deviation 22.4 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 24 | 60.7 mg/dL | Standard Deviation 23.9 |
| Evolocumab in Parent Study: SOC | Apolipoprotein B Level at Week 24 and Week 52 | Parent Study Baseline | 112.4 mg/dL | Standard Deviation 26 |
| Evolocumab in Parent Study: SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 24 | 106.9 mg/dL | Standard Deviation 26 |
| Evolocumab in Parent Study: SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 52 | 109.1 mg/dL | Standard Deviation 27 |
| Evolocumab in Parent Study: Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 24 | 60.9 mg/dL | Standard Deviation 23.1 |
| Evolocumab in Parent Study: Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Week 52 | 61.6 mg/dL | Standard Deviation 23.7 |
| Evolocumab in Parent Study: Evolocumab + SOC | Apolipoprotein B Level at Week 24 and Week 52 | Parent Study Baseline | 110.4 mg/dL | Standard Deviation 24.3 |
Secondary
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52
Time frame: Baseline of parent study and extension study weeks 24 and 52
Population: Participants randomized in study 20110110 and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC-controlled Period: Standard of Care | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 24 | 136.9 mg/dL | Standard Deviation 41.5 |
| SOC-controlled Period: Standard of Care | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 144.6 mg/dL | Standard Deviation 37.4 |
| SOC-controlled Period: Standard of Care | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 52 | 140.5 mg/dL | Standard Deviation 40 |
| SOC-controlled Period: Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 24 | 64.1 mg/dL | Standard Deviation 33.3 |
| SOC-controlled Period: Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 139.7 mg/dL | Standard Deviation 36.7 |
| SOC-controlled Period: Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 52 | 65.0 mg/dL | Standard Deviation 34.4 |
| All-IP Period: SOC / Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 24 | 142.5 mg/dL | Standard Deviation 44.7 |
| All-IP Period: SOC / Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 147.7 mg/dL | Standard Deviation 34.3 |
| All-IP Period: SOC / Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 52 | 143.1 mg/dL | Standard Deviation 39.8 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 24 | 63.9 mg/dL | Standard Deviation 34.6 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 139.5 mg/dL | Standard Deviation 33.6 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 52 | 64.1 mg/dL | Standard Deviation 33.2 |
| Evolocumab in Parent Study: SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 24 | 134.8 mg/dL | Standard Deviation 40.2 |
| Evolocumab in Parent Study: SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 143.4 mg/dL | Standard Deviation 38.5 |
| Evolocumab in Parent Study: SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 52 | 139.4 mg/dL | Standard Deviation 40.1 |
| Evolocumab in Parent Study: Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 139.8 mg/dL | Standard Deviation 37.8 |
| Evolocumab in Parent Study: Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 52 | 65.3 mg/dL | Standard Deviation 34.9 |
| Evolocumab in Parent Study: Evolocumab + SOC | Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 | Week 24 | 64.2 mg/dL | Standard Deviation 32.9 |
Secondary
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52
Time frame: Baseline of parent study and extension study weeks 24 and 52
Population: Participants randomized in the extension study 20110110 and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC-controlled Period: Standard of Care | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 24 | 161.4 mg/dL | Standard Deviation 45.5 |
| SOC-controlled Period: Standard of Care | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 170.7 mg/dL | Standard Deviation 43 |
| SOC-controlled Period: Standard of Care | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 52 | 164.9 mg/dL | Standard Deviation 44.5 |
| SOC-controlled Period: Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 24 | 84.3 mg/dL | Standard Deviation 37.7 |
| SOC-controlled Period: Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 165.1 mg/dL | Standard Deviation 40.9 |
| SOC-controlled Period: Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 52 | 85.3 mg/dL | Standard Deviation 39 |
| All-IP Period: SOC / Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 24 | 166.9 mg/dL | Standard Deviation 47.5 |
| All-IP Period: SOC / Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 173.8 mg/dL | Standard Deviation 39.6 |
| All-IP Period: SOC / Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 52 | 168.8 mg/dL | Standard Deviation 45.3 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 24 | 84.3 mg/dL | Standard Deviation 39 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 165.5 mg/dL | Standard Deviation 38.9 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 52 | 85.0 mg/dL | Standard Deviation 38.4 |
| Evolocumab in Parent Study: SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 24 | 159.4 mg/dL | Standard Deviation 44.6 |
| Evolocumab in Parent Study: SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 169.6 mg/dL | Standard Deviation 44.2 |
| Evolocumab in Parent Study: SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 52 | 163.4 mg/dL | Standard Deviation 44.1 |
| Evolocumab in Parent Study: Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Parent Study Baseline | 165.0 mg/dL | Standard Deviation 41.7 |
| Evolocumab in Parent Study: Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 52 | 85.4 mg/dL | Standard Deviation 39.2 |
| Evolocumab in Parent Study: Evolocumab + SOC | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 | Week 24 | 84.3 mg/dL | Standard Deviation 37.3 |
Secondary
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52
Time frame: Baseline of parent study and extension study weeks 24 and 52
Population: Participants randomized in the extension study 20110110 and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC-controlled Period: Standard of Care | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 24 | 4.198 ratio | Standard Deviation 1.536 |
| SOC-controlled Period: Standard of Care | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Parent Study Baseline | 4.516 ratio | Standard Deviation 1.617 |
| SOC-controlled Period: Standard of Care | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 52 | 4.277 ratio | Standard Deviation 1.652 |
| SOC-controlled Period: Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 24 | 2.603 ratio | Standard Deviation 0.978 |
| SOC-controlled Period: Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Parent Study Baseline | 4.386 ratio | Standard Deviation 1.393 |
| SOC-controlled Period: Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 52 | 2.626 ratio | Standard Deviation 1.025 |
| All-IP Period: SOC / Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 24 | 4.192 ratio | Standard Deviation 1.408 |
| All-IP Period: SOC / Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Parent Study Baseline | 4.458 ratio | Standard Deviation 1.345 |
| All-IP Period: SOC / Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 52 | 4.252 ratio | Standard Deviation 1.434 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 24 | 2.594 ratio | Standard Deviation 0.97 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Parent Study Baseline | 4.388 ratio | Standard Deviation 1.34 |
| All-IP Period: Evolocumab + SOC / Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 52 | 2.622 ratio | Standard Deviation 1.033 |
| Evolocumab in Parent Study: SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 24 | 4.201 ratio | Standard Deviation 1.584 |
| Evolocumab in Parent Study: SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Parent Study Baseline | 4.538 ratio | Standard Deviation 1.708 |
| Evolocumab in Parent Study: SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 52 | 4.286 ratio | Standard Deviation 1.733 |
| Evolocumab in Parent Study: Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Parent Study Baseline | 4.386 ratio | Standard Deviation 1.413 |
| Evolocumab in Parent Study: Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 52 | 2.628 ratio | Standard Deviation 1.023 |
| Evolocumab in Parent Study: Evolocumab + SOC | Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 | Week 24 | 2.607 ratio | Standard Deviation 0.982 |